Podcasts about cabg

In Episode 472, Stacey Richter speaks with Dr. Eric Bricker about the impactful strategies hospital systems use to maximize revenue from high-cost patients. They explore the financial complexities and contracting tactics that enable hospitals to profit significantly from a small percentage of high-cost claimants. Key points include the negotiation of provider stop-loss contract provisions, strategic adjustment of charge masters, and the intentional steerage of patients to high-revenue service lines. This episode highlights the intricacies of hospital finance and the hidden mechanisms that drive healthcare costs for self-insured employers and other plan sponsors. We could have 0.5% to 1% of total plan members costing upwards of 40% of total plan dollars. And I bring this up just to highlight the magnitude of the money here. In that show from last week, we take the issue of high-cost claimants from the standpoint of the plan sponsor. Today, however, we're gonna be looking at this from the standpoint of the hospital system. If we were to come up with a motto for the show today with Dr. Eric Bricker, it's that all costs are somebody else's revenue. And when it's revenue and profit of the magnitude that we're talking about with many high-cost claimants, it starts to be less of an accidental “Oh, wow! How did that CABG patient wind up in our clinic? What are the odds?” and more of a “Whoever is not steering patients is letting someone else with a big profit incentive lock down that steerage in deeply embedded ways.”  === LINKS ===

N Engl J Med 2017;377:2419-2432Background: A small fraction of patients with acute myocardial infarction (5-10%) have cardiogenic shock. These patients have a high baseline mortality. Early revascularization had been established as better than initial stabilization with medical therapy. Many patients with cardiogenic shock due to acute myocardial infarction (AMI) have multivessel disease. The question arises about whether to do culprit-only percutaneous coronary intervention (PCI) or more complete PCI at the time of the initial intervention.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support our work, consider becoming a free or paid subscriber.The Culprit Lesion Only PCI versus Multivessel PCI in Cardiogenic Shock (CULPRIT-SHOCK) trial was designed to test the hypothesis that PCI of the culprit lesion only, with the option of staged revascularization of nonculprit lesions, would result in better clinical outcomes than immediate multivessel PCI among patients who have multivessel coronary artery disease and acute myocardial infarction with cardiogenic shock.Patients: The trial enrolled 706 patients with acute myocardial infarction (ST-segment elevation or non-ST-segment elevation) complicated by cardiogenic shock who had multivessel coronary artery disease. Cardiogenic shock was defined as SBP < 90 mmHg for more than 30 minutes or requiring pressors, clinical signs of pulmonary congestion, and signs of organ hypoperfusion (altered mental status, cold/clammy skin, oliguria, or lactate > 2 mmol/L).Exclusion criteria were extensive and designed to exclude patients with extremely poor prognosis: prolonged resuscitation, no intrinsic heart action, fixed dilated pupils, an indication for urgent CABG, a mechanical cause of shock, age > 90 years, massive pulmonary embolism, or severe renal insufficiency at baseline.Baseline Characteristics: The median age was 70 years, and approximately 75% were male. About 63% of patients had three-vessel disease. More than half the patients had ST-segment elevation myocardial infarction (about 62%), and anterior ST-segment elevation MI accounted for approximately 54% of these cases. About 53% of patients required resuscitation before randomization. The median left ventricular ejection fraction was between 30-33%.Procedures: In the culprit-lesion-only PCI group, only the culprit lesion was treated during the initial procedure, with staged revascularization encouraged based on residual ischemic lesions. In the multivessel PCI group, PCI of all major coronary arteries with >70% stenosis was performed, including attempts to recanalize chronic total occlusions. Crossover from the culprit-lesion-only PCI group to the multivessel PCI group occurred in 12.5% of patients, while crossover in the opposite direction happened in 9.4% of patients. The overall dose of contrast material was significantly higher and the duration of fluoroscopy significantly longer in the multivessel PCI group. Other interventional therapeutic measures were allowed, independent of the assigned treatment strategy.Endpoints: The primary endpoint was a composite of death from any cause or severe renal failure leading to renal-replacement therapy within 30 days after randomization. Secondary endpoints included the individual components of the primary endpoint, recurrent myocardial infarction, rehospitalization for heart failure, repeat revascularization, time to hemodynamic stabilization, catecholamine therapy duration, ICU stay duration, and measurements of renal and myocardial injury. Safety end points included bleeding, which was defined as type 2, 3, or 5 on the Bleeding Academic Research Consortium (BARC) scale.Trialists estimated an event rate of the composite primary endpoint of 38% in the culprit-only group vs 50% in the complete group. Using a global type I error level of 0.05, the authors calculated that a sample of 684 patients would give the trial 80% power to rule out the null hypothesis of no difference between the two treatment groups in the event rate for the primary end point.Results: At 30 days, the composite primary endpoint occurred in 45.9% of patients in the culprit-lesion-only PCI group versus 55.4% in the multivessel PCI group (relative risk, 0.83; 95% CI, 0.71 to 0.96; P=0.01). Death occurred in 43.3% of the culprit-lesion-only PCI group versus 51.6% of the multivessel PCI group (relative risk, 0.84; 95% CI, 0.72 to 0.98; P=0.03). The rate of renal-replacement therapy was 11.6% in the culprit-lesion-only PCI group and 16.4% in the multivessel PCI group (relative risk, 0.71; 95% CI, 0.49 to 1.03; P=0.07).Rates of recurrent myocardial infarction, rehospitalization for heart failure, bleeding, and stroke did not differ significantly between groups. Subgroup analyses showed consistent results across all prespecified subgroups. The time to hemodynamic stabilization, the use of catecholamine therapy and the duration of such therapy, the duration of the ICU stay, and the use of mechanical ventilation and the duration of such therapy also did not differ significantly between the two groups.Conclusion: In patients with myocardial infarction and cardiogenic shock, culprit-only PCI was superior to multivessel PCI. Both components of the primary endpoint, death and severe renal failure were lower in the culprit-only arm. The authors and editorialists speculate why these findings contrast with trials in hemodynamically stable myocardial infarction patients, where early multivessel PCI showed benefit over culprit-only PCI.If you accept the thesis that multi-vessel PCI was superior to culprit-only PCI in stable AMI patients, the likely reason for the disparate results are that patients with cardiogenic shock differ substantially from stable patients. The sicker patients with cardiogenic shock benefit from a less-is-more approach where culprit-only PCI reduces treatment harm relative to multivessel PCI.We at CardiologyTrials, however, find the evidence for complete revascularization in stable AMI patients less than clear. The COMPLETE trial found benefit from multivessel PCI over culprit-only, but both composite endpoints were driven largely by non-fatal MI. CV death was not substantially different. The difference in MI could have been related to excluding procedure-related MI.What's more, the FULL-REVASC trial, which also compared culprit-only and multivessel PCI, failed to replicate the COMPLETE trial results. In FULL-REVASC the rates of the composite primary outcome of death, MI or unplanned revascularization were not significantly different. Sadly, FULL-REVASC was stopped early when COMPLETE results were published, which led to a possible loss of power.It's possible, likely even, that the null results of CULPRIT-SHOCK are not really that disparate from prior trials in patients with more stable AMI.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support our work, consider becoming a free or paid subscriber. Get full access to Cardiology Trial's Substack at cardiologytrials.substack.com/subscribe

N Engl J Med 2005;353:1095-1104Background: Prior trials on revascularization in patients with acute coronary syndromes without ST-segment elevation have yielded mixed results. While FRISC II and TACTICS-TIMI 18 demonstrated a significant reduction in myocardial infarction, this benefit was not observed in RITA 3. None of these trials showed a significant reduction in mortality. Further research is needed to guide treatment strategies in this population, particularly after the introduction of early use of clopidogrel and intensive lipid-lowering therapy.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support our work, consider becoming a free or paid subscriber.The Invasive versus Conservative Treatment in Unstable Coronary Syndromes (ICTUS) trial sough to test the hypothesis that an early invasive strategy is superior to selective invasive strategy for patients with non-ST elevation myocardial infarction (NSTEMI).Patients: Eligible patients had to have all of the following: Worsening symptoms of ischemia or symptoms at rest with the last episode being 24 hours before randomization, elevated cardiac troponin T level (≥0.03 μg per liter); and either ischemic EKG changes (defined as ST-segment depression or transient ST-segment elevation exceeding 0.05 mV, or T-wave inversion of ≥0.2 mV in two contiguous leads) or a documented history of coronary artery disease.Patients were excluded if they were older than 80 years, had an indication for primary percutaneous coronary intervention or fibrinolytic therapy, hemodynamic instability or overt congestive heart failure, oral anticoagulant drugs use in the past 7 days, fibrinolytic treatment within the past 96 hours, percutaneous coronary intervention within the past 14 days, elevated bleeding risk, plus others.Baseline characteristics: The trial randomized 1,200 patients from 42 Dutch hospitals – 604 randomized to early invasive strategy and 596 randomized to selective invasive strategy.The average age of patients was 62 years and 74% were men. Approximately 39% had hypertension, 14% had diabetes, 35% had hyperlipidemia, 23% had prior myocardial infarction and 41% were current smokers.Approximately 48% of the patients had ST deviation equal to or greater than 0.1 mV.Procedures: Patients were randomly assigned in a 1:1 ratio to undergo early invasive vs selective invasive strategy.Patients received 300 mg of aspirin at the time of randomization, followed by at least 75 mg daily indefinitely, and enoxaparin (1 mg/kg for a maximum of 80 mg) subcutaneously twice daily for at least 48 hours. The early use of clopidogrel (300 mg immediately, followed by 75 mg daily) in addition to aspirin was recommended to the investigators after the drug was approved for acute coronary syndrome in 2002. Intensive lipid-lowering therapy, preferably atorvastatin 80 mg daily or the equivalent was recommended as soon as possible after randomization. All interventional procedures during the index admission were performed with the use of abciximab.Patients assigned to the early invasive strategy were scheduled to undergo angiography within 24 - 48 hours after randomization. Patients assigned to the selective invasive strategy underwent coronary angiography if they had refractory angina despite optimal medical therapy, hemodynamic or rhythm instability, or significant ischemia on pre-discharge exercise test.In both groups, percutaneous coronary intervention (PCI) was performed when appropriate, without providing more details in the manuscript.The level of creatine kinase MB was measured at 6-hour intervals during the first day, after each new clinical episode of ischemia, and after each percutaneous revascularization procedure.Endpoints: The primary endpoint was a composite of all-cause death, myocardial infarction, or rehospitalization for angina at 1-year.The estimated sample size to provide 80% power to detect 25% relative risk difference between the two treatment groups at 5% alpha was 1,200 patients. This assumed that 21% of the patients in the early invasive arm would experience the primary outcome.Results: During the index admission, 98% of the patients in the early invasive strategy arm underwent coronary angiogram compared to 53% in the selective invasive arm. At 1-year, 79% of the patients in the early invasive strategy arm underwent revascularization compared to 54% in the selective invasive arm.The primary outcome was not significantly different between both treatment groups (22.7% with early invasive vs 21.2% with selective invasive, RR: 1.07; 95% CI: 0.87 - 1.33; p= 0.33). All-cause death was the same in both groups (2.5%). Myocardial infarction was significantly higher with the early invasive strategy (15.0% vs. 10.0%, RR: 1.50, 95% CI: 1.10 – 2.04; p= 0.005), while rehospitalization for angina was lower with early invasive (7.4% vs. 10.9%, RR: 0.68, 95% CI: 0.47 – 0.98; p= 0.04). Most myocardial infarctions were revascularization related and these were significantly more frequent with early invasive (11.3% vs 5.4%). Spontaneous myocardial infarctions were 3.7% with early invasive and 4.6% with selective invasive and this was not statistically significant.Major bleeding, not related CABG, during the index admission was more frequent with the early invasive strategy (3.1% vs 1.7%).There were no significant subgroup interactions for the primary outcome, including based on ST deviation and troponin levels.Conclusion: In patients with NSTEMI, an early invasive strategy was not superior to selective invasive strategy in reducing the composite endpoint of all-cause death, myocardial infarction, or rehospitalization for angina at 1-year. An early invasive strategy was associated with more myocardial infarctions with a number needed to harm of 20 patients, which was secondary to revascularization related myocardial infarction. An early invasive strategy reduced rehospitalization for angina with a number needed to treat of approximately 29 patients.The ICTUS trial showed that revascularization can cause harm and highlighted how counting procedural myocardial infarctions can influence outcome estimates. While there is ongoing debate about the significance of periprocedural myocardial infarctions, evidence indicates an association with increased mortality. Whether periprocedural myocardial infarctions are 'less severe' than spontaneous myocardial infarctions remains controversial, as their impact varies based on infarct size and patient characteristics. This underscores the importance of including all-cause mortality or advanced systolic heart failure as endpoints in trials of revascularization.Patients in ICTUS received better background medical therapy compared to prior trials in this area. While this could be responsible for the divergent results compared to other prior trials. It also highlights the heterogeneity of NSTEMI patients and that an invasive strategy is not appropriate for all.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support our work, consider becoming a free or paid subscriber. Get full access to Cardiology Trial's Substack at cardiologytrials.substack.com/subscribe

The Lancet 2002;360:743-751Background: The TACTICS-TIMI 18 trial showed that an early invasive strategy in beneficial in selected patients with unstable angina or non-ST-elevation myocardial infarction (NSTEMI). These positive findings contrasted the findings from some earlier studies.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support our work, consider becoming a free or paid subscriber.The British Heart Foundation RITA 3 randomized trial sought to compare invasive vs conservative strategy in patients with unstable angina or NSTEMI, similar to the trial question of TACTICS-TIMI 18.Patients: Eligible patients had suspected cardiac chest pain at rest with at least one of the following: Evidence of ischemia on electrocardiogram (ST depression, transient ST elevation, old left bundle branch block, or T wave inversion), pathologic Q waves suggesting previous myocardial infarction, or documented coronary artery disease on prior coronary angiogram.Patients were excluded if they had evolving myocardial infarction in which reperfusion therapy was indicated. Patients were also excluded if creatine kinase or creatine kinase MB concentrations were twice the upper limit of normal before randomization, if they had myocardial infarction within a month, had percutaneous coronary intervention (PCI) in the previous 12 months, or coronary artery bypass grafting (CABG) at any time.Baseline characteristics: The trial randomized 1,810 patients – 895 randomized to the invasive strategy and 915 randomized to conservative strategy. Patients were recruited from 45 hospitals in England and Scotland.The average age of patients was 63 years and 62% were men. Approximately 35% had hypertension on drugs, 13% had diabetes and 28% had prior myocardial infarction.The majority (92%) of the patients were enrolled because they met the criteria for evidence of ischemia on electrocardiogram.Procedures: Patients were randomly assigned in a 1:1 ratio to undergo invasive vs conservative strategy.In the conservative arm, patients received aspirin and enoxaparin 1mg/kg subcutaneously twice a day for 2-8 days. Beta-blockers, other antiplatelets and glycoprotein IIb/IIIa inhibitors could also be used. Coronary angiography could be performed if patients had anginal symptoms at rest or with minimal exertion despite appropriate therapy or if they had ischemia on stress testing.Patients in the invasive strategy arm received similar medical therapy to the conservative arm. Coronary angiogram was to be performed as soon as possible after randomization and ideally within 72 hours. Revascularization was recommended for lesions of at least 70% stenosis or 50% or more if left main.Endpoints: The trial had two co-primary outcomes. The first was a composite of death from any cause, nonfatal myocardial infarction, or refractory angina at 4 months. The second was a composite of death from any cause or nonfatal myocardial infarction at 1 year.Analysis was performed based on the intention-to-treat principle. The estimated sample size to provide 80% power at 5% alpha, was 1,770 patients. This assumed that 12% of the patients in the conservative arm would experience the outcome of death or non-fatal myocardial infarction at 1-year, and that the invasive strategy would result in 33% relative risk reduction in this outcome.Results: In the invasive strategy, 97% of the patients underwent coronary angiogram at a median of 2 days after randomization, and 55.3% underwent PCI or CABG. In the conservative arm, 10.3% had revascularization during the index admission, and 17.3% had revascularization at 1-year. The median follow time was 2 years and 97% of the patients had at least 1-year of follow up.The first primary composite outcome of death from any cause, nonfatal myocardial infarction, or refractory angina at 4 months was lower with the invasive strategy (9.6% vs 14.5%, HR: 0.66, 95% CI: 0.51 – 0.85; p= 0.001). The second primary composite outcome of death from any cause or nonfatal myocardial infarction at 1 year was not significantly different between both groups (7.6% with invasive vs 8.3% with conservative, HR: 0.91, 95% CI: 0.67 – 1.25; p= 0.58). At 1-year, 4.6% patients died in the invasive arm compared to 3.9% in the conservative arm, and this was not statistically significant. Myocardial infarction at 1-year occurred in 3.8% of the patients in the invasive arm compared to 4.8% in the conservative arm, and this was not statistically significant as well.All bleeding occurred in 8.2% in the invasive arm and 3.5% in the conservative arm.Subgroup analysis showed that men benefited from an invasive strategy while women did not (p for interaction= 0.011). The endpoint of death or myocardial infarction at 1-year, in women, was 5.1% in the conservative arm and 8.6% in the invasive arm, while in men, the incidence of this endpoint was 10.1% in the conservative arm and 7.0% in the invasive arm.Conclusion: In patients with unstable angina or NSTEMI, an invasive strategy compared to conservative strategy, reduced refractory angina but not myocardial infarction or death at 1-year.The reduction in angina is a subjective endpoint, prone to bias and faith healing, as we have previously discussed in other trials of PCI. The reduction in this endpoint alone should not justify widespread adoption of invasive strategy for unstable angina or NSTEMI.A key distinction between this trial and TACTICS-TIMI 18—which demonstrated a reduction in myocardial infarction with an invasive approach—is that this study included patients with smaller myocardial infarctions. Only 41% of participants had ST depression or transient ST elevation, and patients were excluded if creatine kinase or creatine kinase MB levels were more than twice the upper limit of normal before randomization. This highlights the heterogeneity among patients with unstable angina and NSTEMI, where baseline risk and the extent of myocardial necrosis influence treatment effects. We encourage you to read again the subgroup interactions of TACTICS-TIMI 18.Additionally, in the current era, high-sensitivity troponin assays enable the detection of smaller myocardial infarctions, potentially limiting the applicability of older trial results to all present NSTEMI patients.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support our work, consider becoming a free or paid subscriber. Get full access to Cardiology Trial's Substack at cardiologytrials.substack.com/subscribe

N Engl J Med 2001;344:1879-1887Background: Acute coronary syndrome is broadly categorized into unstable angina, non-ST-elevation myocardial infarction (NSTEMI) and ST-elevation myocardial infarction (STEMI). In unstable angina, there is no rise in cardiac biomarkers, although some challenge this clinical entity in the current era of high sensitivity troponins. In NSTEMI, there is elevation of cardiac biomarkers but no ST segment elevation on the electrocardiogram. In STEMI, there is an ST segment elevation on the electrocardiogram as well as a rise in cardiac biomarkers.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support our work, consider becoming a free or paid subscriber.In patients with STEMI, percutaneous coronary intervention (PCI) significantly improves outcomes. However, its role in acute coronary syndrome without ST-segment elevation is less clear for several reasons. Patients with NSTEMI tend to be older and have more comorbidities, increasing procedural risks. This also means that they have competing risks for mortality, potentially reducing the benefit of PCI. Another key challenge is that NSTEMI patients frequently have multivessel disease, making it more difficult to identify the culprit lesion; since there is usually only partial occlusion of the culprit coronary artery. In contrast, there is usually complete occlusion of a coronary artery in STEMI and ST-segment elevation on the electrocardiogram helps localize the infarcted area, making it relatively easy to identify the culprit artery.The findings from previous randomized trials of revascularization in unstable angina and NSTEMI, have been inconsistent. The TACTICS–Thrombolysis in Myocardial Infarction 18 trial sought to compare early invasive vs conservative strategy in patients with unstable angina or NSTEMI.Patients: Eligible patients had angina within 24 hours that was: >20 minutes in duration, accelerating angina, or recurrent episodes at rest or with minimal effort. Patients also had to have one of the following: ST-segment depression of at least 0.05 mV, transient ( 2.5 mg/dL.Baseline characteristics: The trial randomized 2,220 patients – 1,114 randomized to early invasive strategy and 1,106 randomized to conservative strategy.The average age of patients was 62 years and 66% were men. Approximately 28% had diabetes and 39% had prior myocardial infarction.Troponin T levels were elevated (>0.01 ng/ml) in 54% of the patients.Procedures: Patients were randomly assigned in a 1:1 ratio to undergo early invasive vs conservative strategy.Patients received aspirin 325 mg daily, intravenous unfractionated heparin (5000U bolus, followed by an infusion at 1000U/ hour for 48 hours), and intravenous tirofiban (0.4 μg/kg/minute for 30 minutes followed by an infusion of 0.1 μg/kg/minute for 48 hours or until revascularization with tirofiban administered for at least 12 hours after PCI).Patients in the early invasive arm underwent coronary angiogram between 4 and 48 hours after randomization and underwent PCI as appropriate. Patients in the conservative arm were treated medically. If stable, they underwent an exercise-tolerance test before discharged (83% of these tests were with nuclear perfusion or echocardiography imaging). Patients in the conservative arm underwent coronary angiography with PCI if they had angina at rest associated with ischemic EKG changes or elevation in cardiac biomarkers, had clinical instability or had ischemia on their stress test.Endpoints: The primary outcome was a composite of death from any cause, nonfatal myocardial infarction, and rehospitalization for an acute coronary syndrome, at six months.The estimated sample size to provide 80% power was 1,720 patients. This assumed that 22% of the patients in the conservative arm would experience the primary outcome and that the early invasive strategy would result in 25% relative risk reduction in the primary outcome. The sample size was later increased to 2,220 patients.Results: In the early invasive strategy, 97% of the patients underwent coronary angiogram after a medium of 22 hours after randomization, and 60% underwent PCI or CABG. In the conservative arm, 51% underwent coronary angiogram and 36% underwent revascularization during the index hospitalization.The primary composite endpoint was lower with the early invasive strategy (15.9% vs 19.4%, odds ratio: 0.78, 95% CI: 0.62 - 0.97; p= 0.025). The Kaplan-Meier curves started to separate at approximately one week. This benefit was driven by lower myocardial infarction and lower rehospitalization for an acute coronary syndrome with the early invasive strategy; (4.8% vs 6.9%) and (11.0% vs 13.7%), respectively. There was no difference in all-cause death (3.3% vs 3.5%).There were 3 important subgroup interactions. First is based on ST changes where patients with ST changes at presentation had all the benefit with an early invasive strategy (16.4% vs 26.3% [for patients with ST changes] and 15.6% vs 15.3% [for patients without ST changes]). Second is based on Troponin T levels where patients with troponin T> 0.1 ng/mL had significantly more benefit with an early invasive strategy (16.4% vs 24.5% and 15.1% vs 16.6%). The third is based on TIMI score where patients with higher TIMI score had more benefit with an early invasive approach. For a high TIMI score of 5-7, the event rate was 19.5% with early invasive vs 30.6% with conservative approach. Patients with TIMI score of 0-2 had no benefit with an early invasive strategy (12.8% with early invasive vs 11.8% with conservative strategy).Note to readers: TIMI score is a risk stratification tool used to predict 14-day adverse outcomes in patients with unstable angina or NSTEMI. The score ranges from 0 to 7 with higher scores indicating worse prognosis.Conclusion: In patients with unstable angina or NSTEMI, an early invasive strategy reduced the composite endpoint of death from any cause, nonfatal myocardial infarction, and rehospitalization for an acute coronary syndrome at six months with a number needed to treat of approximately 29 patients.The subgroup analysis of this trial is particularly important and biologically plausible, as the presence of ST changes and level of cardiac biomarkers elevation indicate more significant myocardial ischemia or necrosis. Patients without ST changes comprised 62% of the study participants, while those with negative cardiac biomarkers made up 59%, and the study results should not be generalized to these subgroups.Another key consideration is the lack of detailed criteria for what was deemed ‘appropriate' revascularization. Only 60% of patients in the early invasive strategy group underwent revascularization, underscoring that not all patients with unstable angina or NSTEMI benefit from coronary angiography and that further risk stratification is necessary.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support our work, consider becoming a free or paid subscriber. Get full access to Cardiology Trial's Substack at cardiologytrials.substack.com/subscribe

N Engl J Med 2024;390:1481-1492Background: In patients with ST-elevation myocardial infarction (STEMI), opening the culprit artery improves outcomes. Nearly half of STEMI patients have disease in other coronary arteries. Whether revascularizing these non-culprit arteries improves outcomes remained uncertain. The PRAMI trial showed improvement in outcomes with complete revascularization but was relatively small, included 465 patients, and did not require the use of fractional flow reserve (FFR).Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support our work, consider becoming a free or paid subscriber.The FFR-Guidance for Complete Nonculprit Revascularization (FULL REVASC) trial sought to assess if FFR-guided completed revascularization improves outcomes compared to culprit-only percutaneous coronary intervention (PCI).The COMPLETE trial was not published by the time the FULL REVASC trial started enrolling patients.Patients: Eligible patients had STEMI and were undergoing PCI or had high risk NSETMI undergoing urgent PCI. High risk NSTEMI included patients with dynamic ST–T-wave changes, ongoing chest pain, acute heart failure, hemodynamic instability independent of electrocardiographic changes, or life-threatening ventricular arrhythmias.Eligible patients had to have multivessel coronary artery disease, defined as one or more lesions in a nonculprit artery with a diameter of ≥ 2.5 mm and a visually graded stenosis of 50 - 99%.Patients were excluded if they had previous CABG, left main disease or cardiogenic shock.Baseline characteristics: The trial randomized 1,542 patients – 778 randomized to culprit-only PCI and 764 randomized to complete revascularization. Patients were recruited from 32 centers in 7 countries.Approximately 91% of the patients had STEMI and 9% had high risk NSTEMI.The average age of patients was 65 years and 76% were men. Approximately 51% had hypertension, 16% had diabetes, 23% were on treatment for hyperlipidemia, 8% had prior myocardial infarction, and 35% were current smokers.The number of residual coronary arteries with stenosis of 50-99% was 1 in 72% of the patients and 2 or more in the rest.Procedures: Patients were randomly assigned in a 1:1 ratio to undergo culprit-only PCI or FFR-guide complete revascularization. The study was open label.Patients in the culprit-PCI only group did not receive further revascularization during the index hospitalization. Patients in the FFR-guided complete revascularization could receive further revascularization during the index procedure or during the index hospitalization. PCI of non-culprit lesion was recommended if FFR was 0.80 or less.Endpoints: The primary outcome was a composite of death from any cause, myocardial infarction, or unplanned revascularization. The main secondary outcomes were a composite of death from any cause or myocardial infarction and unplanned revascularizationAnalysis was performed based on the intention-to-treat principle. The estimated sample size to achieve 80% with a two-sided alpha of 0.05 was 4,052 patients. This sample size would detect 0.75 risk ratio for the composite outcome of death or myocardial infarction at 1-year assuming 9.9% event rate in the culprit-only PCI. After the publication of the COMPLETE trial, the trial was stopped early due to ethical and feasibility concerns. Consequently, the original key secondary outcome (death from any cause, myocardial infarction, or unplanned revascularization) became the new primary outcome, and events after 1 year of follow-up were included in the primary analysis.Results: The trial was stopped after randomizing 38.1% of the original sample size. Among the patients assigned to the FFR-guided complete-revascularization arm, the procedure was followed in 95.9% of the patients, and among these patients, 17.9% underwent FFR-guided complete revascularization of non-culprit lesions during the primary PCI and the rest during the index hospitalization. Among the patients assigned to culprit-only arm, the assigned strategy was followed in 99.6% of the patients. The median follow-up time was 4.8 years.FFR was 0.8 or less in 392 (47.3%) of non-culprit vessels assessed, and PCI was performed in 369 (94.1%) of these vessels. In total, PCI was performed in 18.8% of the total non-culprit vessels. The average number of stents during the index hospitalization was 1 in the culprit-only PCI group and 2 in the complete revascularization group.The primary composite outcome was not significantly different between both treatment groups (19.0% with complete-revascularization vs 20.4% with culprit-only PCI, HR: 0.93, 95% CI: 0.74 - 1.17; p= 0.53). There were also no significant differences in composite endpoint of death from any cause or myocardial infarction (16.5% with complete revascularization vs 15.3% with culprit-only PCI) or unplanned revascularization (9.2% with complete revascularization vs 11.7% with culprit-only PCI).Stent thrombosis and stent restenosis were significantly more frequent in the complete revascularization arm (2.5% vs 0.9%, HR: 2.80, 95% CI: 1.18 – 6.67) and (4.2% vs 2.3%, HR: 1.84, 95% CI: 1.03 – 3.28), respectively.Baseline risk or coronary anatomy did not significantly affect subgroup interactions for the primary outcome.Conclusion: In patients with STEMI or high risk NSTEMI, FFR-guided complete revascularization compared to culprit-only PCI, did not improve the outcomes of death from any cause, myocardial infarction, or unplanned revascularization, over a median follow up time of 4.8 years. Complete revascularization resulted in more stent thrombosis and stent restenosis.The study lost some statistical power by stopping early, resulting in a final power of 74%. We disagree with the authors' decision to halt the trial prematurely based on the findings of the COMPLETE trial. COMPLETE was the first large trial to demonstrate a benefit in hard outcomes when revascularizing stable plaques, and its results warrant further confirmation. Furthermore, COMPLETE used different strategy as FFR was not required.Note to readers: Power measures the study's ability to avoid a Type II error (false negative) and it equals 1 - β with β being the probability of a Type II error. In other words, power represents the probability of correctly rejecting the null hypothesis (H₀) when the alternative hypothesis (H₁) is true. Most clinical trials aim for 80% or 90% power. For example, a study with 80% power has a 20% risk of failing to detect a real effect.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support our work, consider becoming a free or paid subscriber. Get full access to Cardiology Trial's Substack at cardiologytrials.substack.com/subscribe

N Engl J Med 2013;369:1115-23Background: The COURAGE trial was published in 2007. It compared up-front PCI to medical therapy alone in patients with stable CAD. Preventive PCI did not reduce the chance of dying or having a heart attack over a median follow up time of 5 years. The results rocked the cardiology world because for years prior to the publication of COURAGE, the standard of care called for revascularization of obstructive coronary stenosis. Despite what we would consider minor criticisms of COURAGE, the results have held over time as a preventive PCI strategy has failed repeatedly to reduce death or MI compared to medicine alone in subsequent large trials (BARI 2D, FAME 2, ISCHEMIA and ISCHEMIA-CKD) involving patients with stable CAD. But what about patients with acute coronary syndromes who have, a clearly defined “culprit” lesion and stable coronary stenosis of a non-infarct vessel? On the surface, the answer might seem simple - treat the “culprit” lesion with PCI and leave the stable disease alone. Continue optimal medical treatment of stable CAD indefinitely with consideration of revascularization only if new symptoms arise. But what if a stable coronary stenosis behaves differently in a patient with an acute coronary syndrome than in patients without it? Are these patients predisposed or particularly susceptible to acute plaque rupture and thrombogenesis to such an extent that they would benefit from a preventive revascularization strategy? The Primary Angioplasty in Myocardial Infarction (PRAMI) trial sought to test the hypothesis that immediate preventive PCI of non-culprit vessels plus the culprit vessel compared to culprit vessel only PCI would improve outcomes in patients with a STEMI and coronary stenosis of a non-infarct related artery.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support our work, consider becoming a free or paid subscriber.Patients: From 2008 through 2013, patients were enrolled from 5 coronary care centers in the United Kingdom. Patients could be any age with acute STEMI and multivessel CAD detected at the time of emergency PCI. The trial was limited to patients with STEMI because ST-segment elevation, unlike ST-segment depression, localizes the area of ischemia in the myocardium and an “infarct-artery” is usually easy to distinguish. Clinically stable patients were considered for eligibility after undergoing PCI of the infarct artery while they were in the catheterization lab. They were eligible if successful PCI of infarct artery was performed and there was stenosis of 50% or more in one or more non-infarct arteries. Exclusion criteria included cardiogenic shock, previous CABG, had left main or significant disease in the ostia of both the LAD and circumflex vessels, or if the only non-infarct stenosis was a chronic total occlusion.Baseline characteristics: The trial screened 2,428 patients and randomized 465 patients (19%) with 234 to preventive PCI and 231 to no preventive-PCI. The majority of patients were excluded for single vessel disease (1122/1922 [58%]). The average age of patients was 62 years and more than 75% were men. Close to 50% were current smokers. The infarct artery was anterior in 35%, inferior in 60% and lateral in 5%. Approximately 65% of patients had 2 vessel disease and 35% had 3 vessel disease.Procedures: After completion of PCI in the infarct artery, eligible patients were randomized and those assigned to the preventive-PCI group underwent the procedure immediately in all non-infarct arteries with a coronary stenosis >50%. PCI was discouraged at a later date (sometimes this strategy is referred to as “staged PCI”) in the no preventive-PCI group unless it was symptom driven. Any patient in the trial with subsequent symptoms of angina that were not controlled with medicine was required to undergo objective assessment of ischemia to secure a diagnosis of refractory angina. Follow-up information was collected at 6 weeks and then yearly thereafter.Endpoints: The primary endpoint was a composite of death from cardiac causes, nonfatal MI, or refractory angina. Secondary outcomes included the individual components of the composite endpoint along with noncardiac death and repeat revascularization. Myocardial infarction was defined as symptoms of cardiac ischemia and a troponin level >99% URL. However, within 14 days after randomization, MI diagnosis also required ECG evidence of new STE or left bundle branch block and angiographic evidence of coronary artery occlusion (essentially this makes it so only in-stent thrombosis or spontaneous STEMI count and other causes of peri-procedural MI do not - this would bias the trial in favor of the preventive-PCI group).Refractory angina was defined as angina despite medical therapy and objective evidence of myocardial ischemia (i.e., ischemia on ECG during spontaneous episode of pain or abnormal results on functional testing).It was determined that 600 patients would be needed to achieve 80% power to detect a 30% relative reduction in the preventive-PCI group, at a 5% level of significance, assuming an annual rate of the primary outcome of 20% in the control group. Stopping criteria were prespecified if the results from the trial showed a primary outcome difference at the 0.001 level of significance. Results: The trial was stopped early based on a significant difference (P50%, preventive PCI significantly reduced a primary composite outcome of cardiac death, nonfatal MI and refractory angina in the PRAMI trial with an estimated NNT of 7 patients over 2 years. Individual components of the primary endpoint that were significantly reduced included nonfatal MI and refractory angina by similarly large margins. These results may seem impressive at first glance but we urge extreme caution in their interpretation. First, this is a relatively small trial with a historically large effect size, especially when considering hard endpoints like cardiac death and nonfatal MI were included. Such results are often later found to be falsely positive when larger, confirmatory studies are conducted. Second, the trial was stopped early and early stopping is prone to yield false positive and/or exaggerated results. Third, inclusion of refractory angina in the primary endpoint, an endpoint susceptible to bias in an unblinded study (see earlier discussion of “faith healing” and “subtraction anxiety” in FAME 2; consideration also must be given to nocebo effects in patients who know they have “untreated blockages”), clouds the main findings by inflating the effect size and making the trial susceptible to large differences in underpowered endpoints before sufficient data can be accumulated on hard outcomes. For example, if the trial had sought to detect a conservative difference of 30% in a primary composite endpoint that only included cardiac death or nonfatal MI, based on an event rate of 12% in the control group (the actual event rate in the trial), over 2,200 patients would be needed for 80% power at a 5% level of significance. The estimated number of actual events would be around 230. However, only 47 events occurred in PRAMI making the results highly susceptible to noise.While results of PRAMI suggest a beneficial role for preventive-PCI in patients with STEMI, more evidence is needed to confirm the results.Thanks for reading Cardiology Trial's Substack! This post is public so feel free to share it. Get full access to Cardiology Trial's Substack at cardiologytrials.substack.com/subscribe

This episode of JACC-Baran features a brief discussion on Kendrick Lamar and the history of racial discrimination in the United States. Then Hiroki Ueyama, MD, from Emory University discusses his study on P2Y12 inhibitor pre-treatment in NST-ACS using data from the Chest Pain-MI Registry. The study examines how guideline changes have influenced clinical practice, revealing a decline in pre-treatment rates, significant practice variations, and no major differences in outcomes except for longer hospital stays in CABG patients. Watch the video or listen as a podcast here, then check out the JACC article: https://www.jacc.org/doi/10.1016/j.jacc.2024.09.1227

This week on The Beat, CTSNet Editor-in-Chief Joel Dunning speaks with Dr. Husam Balkhy, Professor of Surgery and the Director of Robotic and Minimally Invasive Cardiac Surgery at University of Chicago Medicine and President of The International Society for Minimally Invasive Cardiothoracic Surgery (ISMICS), about robotic totally endoscopic cardiac surgery procedures. They discuss potential ways to get the world to perform more robot-assisted surgeries, the building blocks to learning robotics, the future of learning robotics, and what to expect this year at the ISMICS 2025 Annual Meeting. They also explore Dr. Balkhy's new President's Series on CTSNet and provide insights into the first video of this series. Joel also highlights some of the videos in the CTSNet Resident Video Competition and the robotics vs VATS debate in Britain.   Joel also reviews recent JANS articles on the impact of restricted chests on long-term lung function parameters following lung transplantation in patients with interstitial lung disease, determinants of inadequate cardioprotection in adult patients with left ventricular dysfunction, engineered heart muscle allografts for heart repair in primates and humans, and risk factor analysis for 30-day mortality after surgery for infective endocarditis.  In addition, Joel explores open repair of descending thoracic and thoracoabdominal aortic aneurysms, totally 3D endoscopic third tricuspid valve replacement, and how to use the Impella for on-pump CABG in patients with low EF. Before closing, he highlights upcoming events in CT surgery.   JANS Items Mentioned  1.) The Impact of Restricted Chests on Long-Term Lung Function Parameters Following Lung Transplantation in Patients With Interstitial Lung Disease    2.) Determinants of Inadequate Cardioprotection in Adult Patients With Left Ventricular Dysfunction  3.) Engineered Heart Muscle Allografts for Heart Repair in Primates and Humans  4.) Risk Factor Analysis for 30-Day Mortality After Surgery for Infective Endocarditis   CTSNET Content Mentioned  1.) Open Repair of Descending Thoracic and Thoracoabdominal Aortic Aneurysms  2.) Totally 3D Endoscopic Third Tricuspid Valve Replacement  3.) ICC 2024 | How I Use the Impella for On-Pump CABG in Patients With Low EF: Insertion, Intraoperative Management, and Weaning/Removal  Other Items Mentioned  1.) President's Series With Husam Balkhy | ISMICS President   2.) ISMICS 2025 Annual Meeting   3.) Career Center   4.) CTSNet Events Calendar  Disclaimer The information and views presented on CTSNet.org represent the views of the authors and contributors of the material and not of CTSNet. Please review our full disclaimer page here.

The TCW Trial compared TAVI + FFR-guided PCI versus SAVR + CABG in patients with severe aortic stenosis and complex coronary artery disease. This multicenter, randomized controlled trial included 172 patients aged ≥70 years. At 1 year, the primary composite endpoint (death, MI, stroke, revascularization, valve reintervention, or major bleeding) was significantly lower in the TAVI + PCI group (4%) compared to SAVR + CABG (23%), meeting both noninferiority and superiority criteria. The study suggests TAVI + PCI as a safer, less invasive alternative with reduced mortality and bleeding risks in selected patients.

This week on The Beat, CTSNet Editor-in-Chief Joel Dunning spoke with Dr. Vinay Badhwar, the current vice president of the Society of Thoracic Surgeons (STS), about his groundbreaking achievement in combining robotic aortic valve replacement (AVR) and coronary artery bypass grafting (CABG) through a single small incision. They discuss the background and premise of this technique, the process of taking this technique from an idea to performing it on a patient, differences between this approach and other cardiac approaches, and the future of cardiac surgery. They also explore the first operation performed using this technique in immense detail with visuals of the procedure.   Joel also highlights recent JANS articles on multisociety endorsement of the 2024 European guideline recommendations on coronary revascularization and bioprosthetic vs mechanical aortic valve replacement in patients 40-75 years. He also reviews short- and long-term outcomes of lung transplantation from brain death vs circulatory death donors and intracavitary cisplatin-fibrin followed by irradiation improved tumor control compared to the single treatments in a mesothelioma rat model.  In addition, Joel explores a Dacron graft double inversion for ascending aorta surgery, a redo mitral valve surgery with previous aortic valve replacement, and a right sinus of Valsalva aneurysm causing right ventricular tract obstruction. Before closing, he highlights upcoming events in CT surgery.   JANS Items Mentioned  1.) Multisociety Endorsement of the 2024 European Guideline Recommendations on Coronary Revascularization  2.) Bioprosthetic vs Mechanical Aortic Valve Replacement in Patients 40-75 Years  3.) Short- and Long-Term Outcomes of Lung Transplantation From Brain Death vs. Circulatory Death Donors: A Meta-Analysis of Comparative Studies  4.) Intracavitary Cisplatin-Fibrin Followed by Irradiation Improved Tumor Control Compared to the Single Treatments in a Mesothelioma Rat Model  CTSNET Content Mentioned  1.) Dacron Graft Double Inversion for Ascending Aorta Surgery  2.) Redo Mitral Valve Surgery With Previous Aortic Valve Replacement  3.) Right Sinus of Valsalva Aneurysm Causing Right Ventricular Tract Obstruction  Other Items Mentioned  1.) CTSNet Career Center 2.) CTSNet Events Calendar  Disclaimer The information and views presented on CTSNet.org represent the views of the authors and contributors of the material and not of CTSNet. Please review our full disclaimer page here.

In this episode, Dr. Mahmoud Diab dives into the technical aspects of minimally invasive coronary artery bypass grafting (CABG). From patient selection to surgical techniques and innovative tools, discover how these advancements are improving outcomes and reshaping cardiac surgery practices.  Dr. Mahmoud Diab is a renowned cardiac surgeon recognized for his expertise in complex heart surgeries and innovative surgical techniques. With a career spanning several decades, he has significantly contributed to advancements in cardiac surgery, particularly in minimally invasive procedures. Dr. Diab's commitment to patient care and surgical excellence has earned him a distinguished reputation in the medical community. He is also a dedicated mentor, training the next generation of cardiac surgeons and continually pushing the boundaries of cardiovascular medicine.    LinkedIn profile: Mahmoud Diab | LinkedIn;   About Behind the OR Behind the OR is the official podcast channel by Peters Surgical. Here, we invite you to step into the world of surgery, where we uncover what happens behind the closed doors of the operating room and beyond. Each episode features in-depth conversations with expert surgeons, providing insights into the latest surgical techniques, innovations, and the daily lives of those who dedicate themselves to saving lives. Founded in 1926, Peters Surgical is a French company with a global presence in over 90 countries. As a reference group for surgical practices worldwide, we are dedicated to improving surgical outcomes through innovative medical devices, including surgical sutures, hemostatic clips, and surgical glue. Our expertise lies in designing, manufacturing, and distributing these devices.  Visit our website here : https://peters-surgical.com/

THE LANCET 2011;377:1409-1420Background: When patients undergo coronary angiography, a hollow tube called a sheath is inserted into an artery. The primary function for the sheath is to provide a stable entry point into the artery, allowing for the safe navigation of instruments to the coronary arteries. Traditionally these sheaths were inserted into the femoral artery. One of the common complications associated with this approach is bleeding which is associated with worse outcomes. An alternative approach is inserting the sheath into the radial artery which is more superficial and more readily compressible compared to the femoral artery.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support our work, consider becoming a free or paid subscriber.Small randomized trials suggested that a radial artery access is associated with less bleeding with possible reduction in death and myocardial infarctions but also a signal of increased percutaneous coronary intervention (PCI) failure.The RIVAL trial sought to assess if radial artery access is superior to femoral artery access in patients with acute coronary syndrome (ACS) undergoing coronary angiography.Patients: Patients had acute coronary syndrome and an invasive strategy was planned. Dual circulation of the hand, as assessed by an Allen's test, had to be intact.Patients were excluded if they had cardiogenic shock, severe peripheral vascular disease precluding a femoral approach, active bleeding or high bleeding risk, or prior coronary artery bypass grafting (CABG) with the use of more than one internal mammary artery graft.Baseline characteristics: The trial randomized 7,021 patients in 32 countries – 3,507 randomized to radial access and 3,514 to femoral access.The average age of patients was 62 years and 73% were men. Approximately 60% had hypertension, 21% had diabetes, 18% had prior myocardial infarction, 2% had prior CABG, 2% had peripheral vascular disease, and 31% were current smokers.The diagnosis at admission was unstable angina in 45% of the patients, NSTEMI in 27% and STEMI in 28%.The use of antiplatelet and anti-thrombotic drugs was not significantly different between both groups.Procedures: The RIVAL trial initially enrolled patients within the CURRENT-OASIS 7 trial which was a trial of antiplatelets therapy in ACS. After the conclusion of the CURRENT-OASIS 7 trial, RIVAL enrolled additional patients.Patients were assigned in a 1:1 ratio to undergo femoral or radial artery access. The use of anti-thrombotic regimen at the time of PCI as well as femoral artery closure devices was at the discretion of the treating physician.Endpoints: The primary outcome was a composite of all-cause death, myocardial infarction, stroke, or non-CABG related major bleeding, within 30 days. Secondary outcomes included the components of the primary outcome as well as major vascular access site complications and PCI procedural success.The components of the primary outcome were adjudicated by a central committee blinded to the treatment assignment. Major vascular access site complications and PCI procedural success were reported by the investigators.Analysis was performed based on the intention-to-treat principle. Due to low event rate, the sample size was increased from 4,000 to 7,000. This new sample size would provide 80% power to detect 25% relative risk reduction in the primary endpoint assuming 6% event rate in the femoral access arm.The study had six prespecified subgroup analysis: Age (< 75 vs older), sex, body mass index, STEMI vs no STEMI, operator's annual radial PCI volume and center's median operator's radial PCI volume.Results: Among the 7,021 randomized patients, 99.8% underwent coronary angiography. The rate of crossover was 7.6% in the radial group and 2.0% in the femoral group. Most of the crossover in the radial group was due to failure of the coronary angiogram using the radial approach. There was no significant difference in the number of PCI catheters used between both groups. Fluoroscopy time was higher in the radial group (7.8 minutes vs 6.5 minutes; p< 0.001).The primary composite outcome at 30-days was not significantly different between both groups (3.7% with radial vs 4.0% with femoral, HR: 0.92, 95% CI: 0.72 – 1.71; p= 0.50). All of the components of the primary outcome were not significantly different between both groups: 1.3% vs 1.5% for death, 1.7% vs 1.9% for myocardial infarction, 0.6% vs 0.4% for stroke, and 0.7% vs 0.9% for non-CABG related major bleeding.PCI procedural success was 95% in both groups. Major vascular complications were lower using the radial approach (1.4% vs 3.7%; p< 0.001). Major vascular complications were defined as pseudoaneurysms needing closure, large hematoma, arteriovenous fistula, or an ischemic limb needing surgery.There were no significant subgroup interactions based on age, sex, body mass index or operator's radial PCI volume. There was significant interaction based on STEMI vs no STEMI (p for interaction= 0.025) and center's radial PCI volume (p for interaction 0.021), such as patients with STEMI and patients in centers with the highest tertile for PCI volume had reduction in the primary outcome with radial access.Significantly more patients in the radial group said to prefer radial approach if they need a future coronary angiography (90.2% vs 50.7%; p< 0.001).Conclusion: In patients with acute coronary syndrome undergoing coronary angiography, a radial approach compared to femoral approach, did not improve the primary composite outcome of all-cause death, myocardial infarction, stroke, or non-CABG related major bleeding, at 30 days. A radial approach reduced major vascular complications with a number needed to treat of approximately 43 patients. A radial artery approach was more commonly preferred by patients for future coronary angiography.One of the limitations of this trial is that the outcome of major vascular complications is subject to bias as it was reported by the investigators rather than centrally adjudicated.Given that this trial compares two approaches with similar costs, the observed reduction in vascular complications justifies an increased adoption of the radial approach. The safety of the radial approach has likely improved over the years as centers and operators have gained more experience. Moreover, patients have shown a clear preference for the radial approach, which is an important win as well.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support our work, consider becoming a free or paid subscriber. Get full access to Cardiology Trial's Substack at cardiologytrials.substack.com/subscribe

N Engl J Med 2009;360:213-24Lancet 2015;386:1853-60Background: Fractional flow reserve (FFR) is a measure of the physiologic significance of a coronary stenosis that is defined as the ratio of maximal blood flow in a stenotic artery to normal maximal flow. It is measured during coronary angiography by calculating the ratio of distal coronary pressure measured with a coronary pressure guidewire to aortic pressure measured simultaneously with the guiding catheter. FFR in a normal coronary artery equals 1.0 whereas a value 90% and is similar to information obtained with stress imaging studies.For patients with multivessel coronary disease, it can be a challenge in the cath lab to differentiate between blockages causing ischemia and those that are not and this may be especially challenging when patients have not undergone stress imaging prior (e.g., patients presenting with acute coronary syndromes without ST segment elevation). The FAME trial sought to test the hypothesis that revascularization guided by FFR would be superior to revascularization guided by angiography alone in a broad cohort of patients with multivessel disease in whom revascularization with PCI was indicated.Patients: Patients with multivessel CAD of at least 50% of the vessel diameter in at least 2 of the 3 major epicardial coronary arteries in whom PCI was indicated. Patients with a STEMI could be included if the infarction occurred at least 5 days before PCI. Patients with a NSTEMI could be included earlier than 5 days. Patients who had undergone previous PCI could be included.Patients were excluded if they had left main coronary disease, previous CABG, cardiogenic shock, extremely tortuous or calcified coronary arteries, a life expectancy less than 2 years, a contraindication to the placement of drug-eluting stents, or if patients were pregnant.Baseline characteristics: Information is not provided on patients screened to enrolled. The average age of patients was 64.5 years and approximately three quarters were men. It is not clear from the main manuscript how many patients presented with acute MI's. It appears that approximately one third of patients presented with unstable angina and about half of these patients had dynamic ECG changes. More than half of patients in the trial had class 2 angina or below. Approximately 25% of patients had diabetes and over 60% had hypertension. The average EF was 57%.The mean number of lesions per patient was 2.8. About 40% of blockages were estimated to be in the 50-70% range, another 40% were in the 71-90% range, 15% were 91-99% narrowed and 3% were chronic total occlusions. The minimal luminal diameter was 1.0 mm, mean reference vessel diameter was 2.5 mm, mean lesion length was 12.5 mm and the SYNTAX score was 14.5.Procedures: Patients were randomized after they were found to have multivessel disease, meeting the study criteria, and were thought to require PCI. Patients assigned to angiography-guided PCI underwent stenting of all indicated lesions with drug-eluting stents. Those assigned to FFR-guided PCI underwent FFR in each diseased coronary artery and drug-eluting stents were placed in lesions with FFR that was /=50% in 2 of 3 major epicardial coronary arteries) and an indication for PCI, that FFR-guidance may reduce stent use and improve outcomes over short-term follow-up. However, more data is needed to confirm this result and to distinguish patient populations most likely to benefit based on clinical indication for PCI and complexity of coronary anatomy.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support our work, consider becoming a free or paid subscriber. Get full access to Cardiology Trial's Substack at cardiologytrials.substack.com/subscribe

In this episode, Dr. Gianluca Torregrossa, a cardiothoracic surgeon at Lankenau Heart Institute in Philadelphia, discusses the advancements and potential of robotic coronary artery bypass grafting (CABG). From minimally invasive techniques to the future of total endoscopic CABG (TCAB), he shares insights into how these innovations improve outcomes, reduce recovery time, and offer new hope for patients with complex coronary artery disease.  Discover how robotic platforms are transforming cardiac surgery and the need to inspire the next generation of specialized surgeons.  Dr TORREGROSSA was graduated from the University of Padua Itlay in 2006. In 2011, he was a part of the team who implanted the first total artificial Heart in Italy. Few years later he was appointed Associate director of Robotic Heart Surgery at Mount Sinai St Luke (NYC), then joined the Cardiac Robotic and Minimally Invasive Division of Surgery at University of Chicago and since 2021 he is the Director of the Robotic Coronary Program in Main Health Hospital Philadelphia. Dr Torregrossa is the author of more than 80 publications in peer-reviewed journals, including 1 book. He serves as reviewer for several journals, and his current h index is 12. Finally, he speaks 4 languages and crossed the Sahara twice on his motorbike.  Visit his LinkedIn profile: Gianluca Torregrossa | LinkedIn   About Behind the OR Behind the OR is the official podcast channel by Peters Surgical. Here, we invite you to step into the world of surgery, where we uncover what happens behind the closed doors of the operating room and beyond. Each episode features in-depth conversations with expert surgeons, providing insights into the latest surgical techniques, innovations, and the daily lives of those who dedicate themselves to saving lives. Founded in 1926, Peters Surgical is a French company with a global presence in over 90 countries. As a reference group for surgical practices worldwide, we are dedicated to improving surgical outcomes through innovative medical devices, including surgical sutures, hemostatic clips, and surgical glue. Our expertise lies in designing, manufacturing, and distributing these devices.  Visit our website here : https://peters-surgical.com/

N Engl J Med 2016;375:1242-1252Background: The first drug-eluting stent (DES) was approved by the FDA in 2003 following the publication of the RAVEL trial. Since then, newer generations of DES were developed and were tested in clinical trials. The majority of trials comparing DES to bare-metal stents (BMS) showed reduction in repeat revascularization with DES but no significant reduction in death or myocardial infarction. Following these publications, the use of DES grew rapidly and was used in more than two thirds of percutaneous coronary interventions (PCI) by 2010.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support our work, consider becoming a free or paid subscriber.These trials, however, were very selective, had short follow up time (TAXUS-IV followed patients for 9 months and SPRIT IV followed patients for 12 months), and had limited power to assess hard outcomes.The NORSTENT trial investigators sought to compare DES to BMS in a more pragmatic design and follow patients for longer time.Patients: All patients who were undergoing PCI in Norway were assessed for enrollment. Patients had stable angina or acute coronary syndrome. Lesions were in native coronary arteries or bypass grafts.Patients were excluded if they had prior coronary stents, bifurcating lesions requiring a two-stent technique or life expectancy less than 5 years due to a medical condition other than coronary artery disease. Patients were also excluded if they had contraindications to dual antiplatelets or were taking warfarin.Baseline characteristics: The trial randomized 9,013 patients – 4,504 randomized to receive a DES and 4,509 to receive a BMS.The average age of patients was 63 years and 75% were men. Approximately 42% had hypertension, 54% had hyperlipidemia, 10% had prior myocardial infarction, 7% had prior CABG, 12% had diabetes, and 35% were current smokers.The indication for PCI was stable angina in 29% of the patients, unstable angina in 12% and STEMI or NSTEMI in 58%.Procedures: The study was open-label but outcomes assessment was blinded. Patients were randomly assigned in a 1:1 ratio to receive DES or BMS. Patients could receive several stents as clinically indicated but can only receive the assigned stent type during the index procedure.In all patients, aspirin 75 mg daily was given indefinitely while clopidogrel 75 mg daily was given for 9 months.Follow up visits were done as clinically appropriate without specification from the study protocol. Similarly, no routine follow up coronary angiography was performed.Endpoints: The primary outcome was a composite of all-cause death or spontaneous myocardial infarction. Secondary outcomes included repeat revascularization, stent thrombosis, major bleeding and health status based on the Seattle Angina Questionnaire.Clinical outcomes were collected by linking each patient unique national identification number to the Norwegian national patient registry.Analysis was performed based on the intention-to-treat principle. The study planned to enroll 8,000 patients to be followed for a median of 5 years. Assuming the 5-year event rate of the primary outcome to be 17%, the study would provide 93% power to detect 3% absolute risk difference between the study groups (rate ratio: 1.18). Due to lower than expected mortality, the sample size was increased to 9,000 patientsResults: Among the 20,663 patients who were assessed for eligibility, 12,425 met inclusion criteria. Among patients who met inclusion criteria, 9,013 were randomized. Figure 1 in the manuscript provides details for excluding patients and for not randomizing patients who met eligibility criteria. The most common reason for exclusion was prior PCI.The number of stents implanted per patient was 1.7 and more than 98% received the assigned stent type. The median follow up time was 5 years.The primary composite outcome of all-cause death or nonfatal spontaneous myocardial infarction was not significantly different between both treatment arms (16.6% with DES vs 17.1% with BMS, HR: 0.98; 95% CI: 0.88 - 1.09; p= 0.66).For the secondary outcomes – Hospitalization for unstable angina was similar between treatment groups (5.2% vs. 5.7%; p= 0.21). Stent thrombosis was lower with DES (0.8% vs 1.2%; p= 0.05). Target-lesion revascularization was also lower with DES (5.3% vs 10.3%; p< 0.001). Bleeding Academic Research Consortium (BARC) 3, 4 or 5 was similar between groups (5.5% vs 5.6%; p= 0.88).There was no significant difference in health status based on the Seattle Angina Questionnaire.There were no significant subgroup interactions.Conclusion: In patients undergoing PCI, the use of DES did not reduce the composite endpoint of death or spontaneous myocardial infarction compared to BMS. Target-lesion revascularization was reduced with DES with a number needed to treat of 20 patients.The findings of this study align with the results of other trials comparing DES to BMS. We have reviewed several key trials and included links to additional studies in this field below. Overall, DES significantly reduce target-lesion revascularization without significant effect on all-cause mortality or myocardial infarction.An important consideration in this and other related trials is that both stent types were studied using similar durations of dual antiplatelet therapy (DAPT) following PCI. For patients with stable angina, BMS typically require only one month of DAPT, while DES often necessitate three to twelve months. Since shorter durations of DAPT are generally safer for patients, a trial comparing DES with three to twelve months of DAPT compared to BMS with one month of DAPT would be insightful.A final teaching point is that less than 50% of screened patients were ultimately enrolled in this pragmatic trial, which had minimal exclusion criteria. It's not uncommon for trials to enroll less than 5% of screened patients which limits their external validity.* Other trials of DES vs BMShttps://pubmed.ncbi.nlm.nih.gov/21080780/https://pubmed.ncbi.nlm.nih.gov/22951305/Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support our work, consider becoming a free or paid subscriber. Get full access to Cardiology Trial's Substack at cardiologytrials.substack.com/subscribe

This week on The Beat, CTSNet Editor-in-Chief Joel Dunning pays tribute to the late-cardiac surgeon Albert Starr. He discusses Dr. Starr's personal and professional life, his accomplishments, and the Starr-Edwards valve. He also discusses the background of CTSNet, provides a quick statistics review of CTSNet, and the CTSNet career center.   Joel also reviews recent JANS articles on heart surgeons performing the world's first combined robotic AVR and CABG, the prevalence of invasive lung cancer in pure ground glass nodules less than 30 mm, external validation of EuroSCORE I and II in patients with infective endocarditis, and totally endoscopic coronary artery bypass graft.   In addition, Joel explores robotic-assisted tracheobronchoplasty, spontaneously closed VSD presenting as an Iatrogenic Gerbodie defect, and single leaflet neocuspidization for aortic regurgitation due to infective endocarditis in adult congenital heart disease. Before closing, he highlights upcoming events in CT surgery.   JANS Items Mentioned  1.) Heart Surgeons Perform World's First Combined Robotic AVR and CABG  2.) Prevalence of Invasive Lung Cancer in Pure Ground Glass Nodules Less Than 30 mm: A Systematic Review  3.) External Validation of EuroSCORE I and II in Patients With Infective Endocarditis: Results From a Nationwide Prospective Registry  4.) Totally Endoscopic Coronary Artery Bypass Graft: Systematic Review and Meta-Analysis of Reconstructed Patient-Level Data  CTSNET Content Mentioned  1.) Robotic-Assisted Tracheobronchoplasty: A Quick Way to Fix the Airway  2.) Spontaneously Closed VSD Presenting as an Iatrogenic Gerbodie Defect  3.) Single Leaflet Neocuspidization for Aortic Regurgitation Due to Infective Endocarditis in Adult Congenital Heart Disease  Other Items Mentioned  CTSNet Events Calendar  Disclaimer The information and views presented on CTSNet.org represent the views of the authors and contributors of the material and not of CTSNet. Please review our full disclaimer page here.

Incorporate this specific data on the efficacy and safety of SGLT2Is into the larger body of literature on SGLT2Is. Full text of the manuscript is available at: https://accpjournals.onlinelibrary.wiley.com/doi/10.1002/phar.4620.

Send us a textGrab your trainers, your dog lead, your jingle bells, or a cuppa and join us for some free CPD as we have another relaxed round up of recent Red Whale primary care Pearls of wisdom. In the first of two episodes this month, Fiona and Nik discuss: Chronic urticaria. How confident are you in spotting and managing it?Preparing for the worst…we consider the important issue of bleeding and haemorrhage in advanced cancer.  Listen as soon as you can to ensure you have full access to all the free resources. The rest of the Pearls from November will be covered next week along with a new best intentions story to put a smile on your face.LinksScottish Palliative Care Guidelines - bleedingFestive i-CPDWhat we can learn from watching the film 'Last Christmas' ? - Boggled Docs episodeWhat we can learn from watching 'The Muppet Christmas Carol' ?- Boggled Docs episodeSend us your feedback podcast@redwhale.co.uk or send a voice message Sign up to receive Pearls here. Pearls are available for 3 months from publish date. After this, you can get access them plus 100s more articles when you buy a one-day online course from Red Whale OR sign up to Red Whale Unlimited. Find out more here. Follow us: X, Facebook, Instagram, LinkedInDisclaimer: We make every effort to ensure the information in this podcast is accurate and correct at the date of publication, but it is of necessity of a brief and general nature, and this should not replace your own good clinical judgement, or be regarded as a substitute for taking professional advice in appropriate circumstances. In particular, check drug doses, side-effects and interactions with the British National Formulary. Save insofar as any such liability cannot be excluded at law, we do not accept any liability for loss of any type caused by reliance on the information in this podcast....

N Engl J Med 2004;350:221-31Background: For the past year we have been posting reviews of seminal trials in cardiovascular medicine. It is our anticipation that these will ultimately be published in a textbook format that will be indexed by major subject headings and the reviews will be presented in chronological order. However, in curating postings for Substack we have had to jump around in order to maintain some consistency in the topics being presented. We started this year by reviewing medical therapies for patients with acute coronary syndrome. After that we moved to the management of patients with mostly stable coronary artery disease and have completed reviews on trials involving CABG and percutaneous coronary interventions compared to medical therapy and to each other, in the case of patients with left main and multivessel disease. In completing that stream of trials, we intentionally skipped trials that have been instrumental in developing those techniques, especially coronary stenting. While perhaps not that important to general readers, medical trainees, especially in the field of cardiovascular medicine need to be familiar with these trials. They are not intended to address questions involving stenting versus medical care but instead, to address the question of “If you're going to stent, is it better to use product A or B?”In that vein, we recently reviewed the RAVEL trial that compared sirolimus-eluting stents to bare metal stents. This is an issue of interest because a common problem following PCI is restenosis of the treated area due to the process of neointimal proliferation that involves the migration and proliferation of smooth muscle cells from the injured arterial wall. The idea behind drug coated stents was that the drug coatings would reduce this process locally (at the level of stented arterial wall) by blocking the process of neointimal proliferation and hyperplasia, which is not the same as atherosclerosis.RAVEL was a small trial showing that a sirolimus-eluting stent improved the surrogate endpoint of in-stent luminal loss at 6 months compared to a bare metal stent. The TAXUS-IV trial was undertaken for similar purposes but on a larger scale and sought to test a more clinically relevant endpoint. It sought to test the hypothesis that a paclitaxel-eluting stent would reduce ischemia-driven target-vessel revascularization compared to a bare metal stent.*Note to learners: A common parlance for describing stents in the clinical setting is to refer to them based on generation (e.g., first, second, or third generation). First generation stents are bare metal stents. Second and third generation stents are drug eluting stents with newer generations often featuring improved biocompatibility and drug delivery mechanisms. Sirolimus- and paclitaxel-eluting stents are considered second generation stents.Patients: Patients had to be 18 years of age or older, have stable or unstable angina or provokable ischemia, and were undergoing PCI for a single, previously untreated lesion in a native coronary artery. Angiographic inclusion required a single target lesion with a reference-vessel diameter on visual examination of 2.5 to 3.75 mm and a lesion length of 10 to 28 mm that could be covered by a single study stent. There were many exclusion criteria that can be summarized as follows: acute MI, complex coronary disease (including left main, ostial target lesion or bifurcating target lesion), complex patient and predisposition to bleeding.Baseline characteristics: The average age of patients was 62 years and 72% were men. Approximately 30% of patients had diabetes with nearly a quarter requiring insulin. Over 20% were smokers and 30% had a previous MI. The average LV EF was 55%. The target lesion was located in the LAD in 40%, the circumflex in close to 30% and the right coronary artery in 30%. The reference-vessel diameter was >/=3.0 mm in over 75% of patients. The average lesion length was 13 mm, average reference-vessel diameter was 2.75 mm, average minimal luminal diameter was 0.92 mm, and average % stenosis was 66%.Procedures: Patients were assigned in equal proportions in a double-blind fashion to treatment with either the paclitaxel-eluting stent or a visually indistinguishable bare-metal stent. Unfractionated heparin was administered according to standard practice, and the use of glycoprotein IIb/IIIa inhibitors was at the operator's discretion. After mandatory balloon dilation, patients received an appropriately-sized stent. A postprocedural electrocardiogram was obtained, and cardiac enzymes were measured every 8 hours for 24 hours. Patients took 325 mg of aspirin daily indefinitely and 75 mg of clopidogrel daily for 6 months. Clinical follow-up was scheduled at 1, 4 and 9 months and yearly thereafter for 5 years.Endpoints: The primary end point was the 9 month incidence of ischemia-driven target-vessel revascularization. It was considered to be “ischemia driven” if the stenosis of the target vessel was at least 50% of the luminal diameter on the basis of quantitative analysis with either: 1) ECG changes while the patient was at rest or 2) a functional study indicating ischemia in the distribution of the target vessel. It was also considered “ischemia driven” if there was a 70% stenosis in conjunction with recurrent symptoms alone.*It should be noted that in this case “ischemia driven” does not necessarily mean symptom driven.Major adverse cardiac events were defined as death from cardiac causes, MI, or ischemia-driven target-vessel revascularization. Target-vessel failure was defined as death, MI or ischemia-driven target vessel revascularization related to the target vessel. Analysis was based on the intention-to-treat principle. A total of 1172 patients were needed to detect a 40% relative reduction (6% absolute reduction) in the primary endpoint based on an anticipated event rate of 15% in the bare-metal stent group. This sample size would have 85% power with an alpha level of 0.05 to detect the difference described above while allowing for a drop out rate of 10%.Results: A total of 1,326 patients were enrolled over a 3 month period from 73 US centers and 1,314 were included in the final analysis with 662 in the paclitaxel-eluting stent group and 652 in the bare-metal stent group. The initial angiographic results were similar in the 2 groups.At 9 months, paclitaxel-eluting stents reduced the primary endpoint of ischemia-driven target vessel revascularization by 61% (4.7% vs 12.0%; RR 0.39; 95% CI 0.26-0.59). There were no differences in death from cardiac causes (1.4% vs 1.1%), MI (3.5% vs 3.7%), or stent thrombosis (0.6% vs 0.8%). In a prespecified subset of patients who underwent coronary angiography at 9 months, paclitaxel-eluting stents were associated with better angiographic features compared to bare-metal stents.Conclusions: In patients with stable and unstable angina (not acute MI), paclitaxel-eluting stents significantly reduced ischemia-driven target vessel revascularization at 9 months of follow-up with a number needed to treat of approximately 14 patients. There were no differences in any hard endpoints. While some would hail this as a remarkably positive trial we have reservations. Firstly, the primary endpoint is not symptom-driven and it should be regarded as a surrogate endpoint. At the time this trial was undertaken it was routine practice for patients to undergo surveillance testing with ECG's and functional tests following coronary revascularization and this is likely how the majority of patients came to undergo revascularization (not via a symptom-driven route). Had these elective revascularizations not occurred, it is unknown whether it would have resulted in any deleterious consequences.Second, patients enrolled in the trial were highly selected and no information is provided in the main manuscript on how many underwent screening. Commonly-occurring angiographic features of coronary lesions, for which patients undergo PCI, were excluded (i.e., ostial and bifurcating lesions, lesions in vessels with reference vessel diameters

For full review of the trials, please visit https://cardiologytrials.substack.com/ Get full access to Cardiology Trial's Substack at cardiologytrials.substack.com/subscribe

In the December 10, 2024 JACC issue, a study from the EXCEL trial examines the link between bleeding complications and mortality in patients with left main coronary artery disease undergoing PCI or CABG. The findings highlight that while PCI showed lower rates of bleeding, both procedures had bleeding-related mortality risks, underscoring the need for strategies to minimize bleeding during and after revascularization.

In the December 2024 issue of JACC, Dr. Valentin Fuster summarizes five pivotal clinical studies, including one on bleeding and mortality following revascularization for left main coronary artery disease, which highlights higher bleeding rates post-CABG compared to PCI. Other key articles explore the use of the MitraClip in treating moderate-to-severe functional mitral regurgitation, evaluating its impact on hospitalization and quality of life, as well as comparing aspirin monotherapy to no antiplatelet therapy in patients undergoing low-risk non-cardiac surgery, and testing a novel low-dose triple pill for hypertension.

Join our hosts Can Gollmann-Tepeköylü and Miia L Lehtinen for their late-breaking trials highlights presented at the 38th EACTS Annual Meeting in Lisbon, including: (0:39 - 4:31) Long-term mortality after PCI or CABG in patients with diabetes and multivessel coronary artery disease: A SWEDEHEART study by Dr Emma C Hansson (4:32 - 8:33) Long-term (>10 years) results of transcatheter Mitral valve-in-valve implantation for degenerated surgical mitral bioprosthesis: Italian MItral VIV registry (MIVIV registry) by Dr Edoardo Zancanaro  (8:34 - 11:55) Personalized multimodal teleprehabilitation in elective cardiac surgery: results from the Digital Cardiac Counselling multicentered randomized Controlled Trial (ClinicalTrials.gov number, NCT04393636.) by Dr Bart Scheenstra   (11:55 - 16:15) 5-Year Results on Aortic Remodeling in the Dissected Aorta Repair Through Stent (DARTS) Implantation Trial by Dr Ryaan EL-Andari (16:16 - 19:49) Clinical impact of continuous postoperative pericardial flushing on bleeding-related complications after cardiac surgery by Dr Robert Klautz

N Engl J Med 2009;360:2503-2515Background: Type 2 diabetes increases the risk of cardiovascular events and death. Previous trials comparing revascularization versus medical therapy included patients with diabetes, however, a large-scale trial specifically focusing on patients with type 2 diabetes was lacking.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial sought to assess the optimal treatment strategy for patients with type 2 diabetes and stable coronary artery disease.Patients: Eligible patients had type 2 diabetes and stable coronary artery disease. Coronary artery disease was defined as a stenosis in a major coronary artery of 50% or more and a positive stress test or 70% or more and classic angina. Patients had to be candidates for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) without further specification.Patients were excluded if they had left main disease, prior PCI or CABG within 12 months, class III or IV heart failure, hepatic dysfunction, creatinine> 2 mg/dL or glycated hemoglobin> 13%.Baseline characteristics: The trial randomized 2,368 patients – 1,176 randomized to the revascularization arm and 1,192 to the medical therapy arm. Among the 1,176 patients in the revascularization arm, 32% were planned to undergo CABG and 68% planned to undergo PCI.The average age of patients was 62 years and 70% were men. The mean glycated hemoglobin was 7.7% and the mean duration of diabetes was 10.4 years. Approximately 32% had prior myocardial infarction, 7% had congestive heart failure and 24% had peripheral artery disease. Approximately 18% had no angina or angina equivalent. Angina class within 6 weeks was 1-2 in 43% of the patients and 3-4 in 9%.The mean left ventricular ejection fraction was 57%. Approximately 31% had three-vessel disease and 13% had proximal left anterior descending artery disease.Baseline characteristics were well balanced between the revascularization arm and the medical therapy alone arm. However, patients who were in the CABG stratum had more three-vessel disease (52% vs 20%) and more proximal left anterior descending artery disease (19% vs 10%).Procedures: The trial was a 2 x 2 factorial design and patients were randomly assigned to two treatment strategies. The first was randomization to revascularization or medical therapy. The second was randomization to insulin-sensitization therapy or insulin-provision therapy. Randomization was stratified based on the method of revascularization (PCI vs CABG) which was determined by the treating physician.In this review, we will focus on the first strategy of revascularization vs medical therapy.For patients randomized to the revascularization arm, the procedure was to be performed within 4 weeks after randomization. Patients in the medical arm could receive revascularization on follow up for any of the following: Progression of angina, acute coronary syndrome or severe ischemia.Patients were seen monthly for the first 6 months and every 3 months thereafter.Endpoints: The primary endpoint was death from any cause. Secondary end point was a composite of death, myocardial infarction, or stroke.Analysis was performed based on the intention-to-treat principle. The original sample size of 2,800 patients was not met, and therefore, the average follow up time was increased by 1.5 years to become 5.3 years. Using the new follow up duration, the study had 88% power to detect a 33% relative risk reduction of death (from 14.0% to 9.8%), and a 95% power to detect a 25% relative risk reduction in the secondary composite endpoint (from 24.0% to 18.0%).Results: Among the patients randomized to the revascularization arm, 95.4% underwent revascularization at 6 months compared to 13.0% of the patients randomized to the medical arm. At 5-years, 42.1% of the patients randomized to the medical arm had undergone revascularization. Among patients who underwent PCI in the revascularization arm, procedures were attempted on average of 1.5 lesions and 56.0% received a bare metal stent. Among patients who underwent CABG in the revascularization arm, 94.2% received an internal mammary artery graft and the mean number of distal anastomoses was 3.0.The average follow up time was 5.3 years.There was no significant difference in the primary outcome of all-cause death. Survival was 88.3% in the revascularization arm and 87.8% in the medical arm (difference: 0.5%; 95% CI: −2.0 - 3.1; p=0.97). There was also no significant difference for the secondary composite endpoint. Freedom from events for the secondary endpoint was 77.2% in the revascularization arm and 75.9% in the medical arm (difference: 1.3%; 95% CI, −2.2 - 4.9; p=0.70).Survival was not significantly different between both treatment strategies in the CABG stratum (86.4% with revascularization vs 83.6% with medical therapy; p= 0.33). However, patients in the CABG stratum had more freedom from the secondary composite endpoint (77.6% vs 69.5%; p= 0.01).In the PCI stratum, revascularization did not improve survival (89.2% with revascularization vs. 89.8% with medical therapy; p= 0.48) or freedom from the secondary composite endpoint (77.0% with revascularization vs 78.9% with medical therapy; p= 0.15).Conclusion: In patients with type 2 diabetes and stable coronary artery disease, revascularization compared to medical therapy did not improve the primary outcome of all-cause death, or the composite secondary outcome of death, myocardial infarction or stroke over an average follow up time of 5.3 years.The observed benefit of revascularization within the CABG stratum should be viewed as hypothesis-generating rather than conclusive evidence that CABG is superior to PCI in this patient population.One potential limitation of this trial is that the authors included patients who were candidates for either PCI or CABG without providing enough details on what makes someone not a candidate. This lack of clarity limits physicians' ability to fully understand which patients would have been suitable for inclusion.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber. Get full access to Cardiology Trial's Substack at cardiologytrials.substack.com/subscribe

JACC Associate Editor Seng Chan You, MD, and author Hiroki Ueyama, MD discuss this study presented at AHA and published in JACC. NCDR study finds a steady decline in P2Y12 inhibitor pretreatment for NSTE-ACS in the US, but significant variability persists among operators, institutions, and regions. This practice was not associated with any benefits but was linked to a longer length of stay among those undergoing CABG, underscoring the importance of maintaining efforts to integrate evidence into clinical practice.

This week on The Beat, CTSNet Editor-in-Chief Joel Dunning had the opportunity to speak with Professor Enoch Akowuah about challenges facing cardiothoracic surgery. They discuss the importance of clinical trials, the best aortic valve replacement technique, and the vision for the future of cardiothoracic surgery. They also discuss how to improve the specialty, what changes are needed in training, and the great part about being a member of a national society.   Joel also reviews recent JANS articles on better survival with lobectomy versus sublobar resection in patients with hypermetabolic c-stage IA lung cancer on positron emission tomography/computed tomography, right anterior minithoracotomy approach for aortic valve replacement, clinical and financial outcomes of pulmonary resection for lung cancer in safety net hospitals, and the 10 commandments for proximal anastomosis during CABG.   In addition, Joel celebrates the winners of the 2024 CTSNet Innovation Video Competition: “How to Perform MIDCAB Using BIMA,” “Mitral Valve Replacement and Coronary Revascularization Via the Left Anterior Minithoracotomy,” and “The Mitral Patch Technique for Mitral Annular Calcification (MAC).” He also discusses a recent interview with professor and surgeon Dr. Shaf Keshavjee. Before closing, he shares upcoming events in CT surgery.   JANS Items Mentioned  1.) Better Survival With Lobectomy Versus Sublobar Resection in Patients With Hypermetabolic C-Stage IA Lung Cancer on Positron Emission Tomography/Computed Tomography    2.) Right Anterior Minithoracotomy Approach for Aortic Valve Replacement  3.) Clinical and Financial Outcomes of Pulmonary Resection for Lung Cancer in Safety-Net Hospitals  4.) The 10 Commandments for Proximal Anastomosis During CABG: Techniques and Technologies for Vein and Arterial Grafts  CTSNET Content Mentioned  1.) How to Perform MIDCAB Using BIMA  2.) Mitral Valve Replacement and Coronary Revascularization Via the Left Anterior Minithoracotomy  3.) The Mitral Patch Technique for Mitral Annular Calcification (MAC)  4.) Keynote Speech: An Interview With Shaf Keshavjee  Other Items Mentioned  CTSNet Events Calendar  Disclaimer The information and views presented on CTSNet.org represent the views of the authors and contributors of the material and not of CTSNet. Please review our full disclaimer page here.

In this episode, we're diving into the essentials of Coronary Artery Bypass Grafting (CABG). We'll start by breaking down the primary indications for CABG, helping you understand why patients need this life-saving surgery. From there, we'll explore the surgical procedure itself, including an overview of graft sites and the differences between on-pump and off-pump techniques. Finally, we'll wrap up with key insights on post-op management, covering what to watch for in the ICU, including fluid resuscitation, hemodynamic stability, and common complications. This is your go-to guide for mastering CABG in the ICU! Etsy (Get the CABG Crash Course HERE) Facebook Instagram TikTok: @nursedosepodcast www.nursedose.org This podcast is intended for informational and educational purposes only. It is not intended to provide medical advice or to substitute for the advice provided by your own physician or other medical professionals. The information contained herein is not intended to diagnose, treat, cure, or prevent any disease. If you have any concerns or questions about your health, you should always consult with a physician or other healthcare professional. The opinions expressed in this podcast are those of the host and guests and do not necessarily reflect the views of any medical institution, organization, or employer. By listening to this podcast, you agree to hold harmless the host, guests, and any associated parties from any and all liability or damages arising from your use of the information provided.

N Engl J Med 2022;386:128-137Background: Patients with three-vessel coronary artery disease have better outcomes when revascularization is performed using coronary artery bypass grafting (CABG) compared to percutaneous coronary intervention (PCI), as seen in the SYNTAX and FREEDOM trials. Fractional flow reserve (FFR) was not required and was not routinely performed in these trials.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.The Fractional Flow Reserve versus Angiography for Multivessel Evaluation (FAME) 3 trial sought to compare the outcomes of FFR-guided PCI vs CABG in patients with three-vessel coronary artery disease.Patients: Eligible patients had three-vessel coronary artery disease defined as 50% or more stenosis, by visual estimation, in any of the three major coronary arteries or major branches. Lesions had to be amenable to revascularization by PCI and CABG as determined by the heart team.Major exclusion criteria were left main disease, cardiogenic shock, STEMI within 5 days, active NSTEMI with cardiac troponin still rising, left ventricular ejection fraction

N Engl J Med 2016;375:2223-2235Background: Smaller randomized trials have shown that outcomes are not significantly different when patients with left main disease are treated with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). In the subgroup of patients with left main disease in the SYNTAX trial, outcomes were similar between PCI and CABG in patients with low or intermediate SYNTAX score but PCI was associated with worse outcomes in patients with high SYNTAX score.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.The Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial sought to assess if PCI was noninferior to CABG in patients with left main coronary artery disease.Patients: Eligible patients had left main stenosis of 70% or more. Patients with stenosis of 50% to 69% were enrolled if the stenosis was hemodynamically significant as determined by non-invasive or invasive testing. Patients were also required to have low or intermediate SYNTAX score defined as a score of 32 or less.Patients were excluded if they had prior PCI to the left main coronary artery, PCI to any other coronary artery within 1 year, prior CABG, a need for a concomitant cardiac surgery, elevated CK-MB, or life expectancy less than 3 years due to non-cardiac conditions.Baseline characteristics: The trial randomized 1,905 patients – 948 randomized to PCI and 957 to CABG.The average age of patients was 66 years and 77% were men. Approximately 74% had hypertension, 70% had hyperlipidemia, 29% had diabetes, 17% had prior myocardial infarction and 22% were current smokers. The average left ventricular ejection fraction was 57%.The clinical presentation was myocardial infarction within 7 days in 14% of the patients, unstable angina in 24%, stable angina in 53%, and silent ischemia or other in 8%.Distal left main bifurcation or trifurcation disease was present in 81% of the patients, and 2- or 3-vessel coronary artery disease was present in 51%. SYNTAX score based on a core laboratory evaluation was low (22 or less) in 36% of the patients, intermediate (23-32) in 40% and high (33 or more) in 24%. However, based on site assessment, SYNTAX score was low in 61% of the patients and intermediate in 39%.Procedures: Patients were randomly assigned in a 1:1 ratio to undergo CABG or PCI using fluoropolymer-based cobalt–chromium everolimus-eluting stents (XIENCE, Abbott Vascular). Randomization was stratified based on the presence of diabetes, SYNTAX score (low vs intermediate) and study center.Dual antiplatelets were given for at least 12 months following PCI.CABG was performed with or without cardiopulmonary bypass based on the operator discretion. The use of arterial grafts was recommended.Endpoints: The primary endpoint was a composite of death from any cause, myocardial infarction and stroke at 3 years. Secondary endpoints included the components of the primary endpoint as well as repeat revascularization.Analysis was performed based on the intention-to-treat principle. Sample size was calculated based on non-inferiority. The sample size to provided 80% power with one-sided alpha of 0.025 was 1,900 patients. This calculation was based on an assumed 11% event rate in each study group and 4.2% absolute difference non-inferiority margin.The original sample size was 2,600 patients which would have provided 90% power. However, both were adjusted due to slow enrollment.Results: Among the 948 patients assigned to the PCI arm, 99% underwent the procedure. The mean number of stents implanted per patient was 2.4. Among the 957 patients assigned to the CABG arm, 96% underwent the surgery. The mean number of grafts per patient was 2.6. An internal mammary artery graft was used in 99% of the patients. The median follow up time was 3 years.The primary composite endpoint was not significantly different between CABG and PCI (14.7% with CABG vs 15.4% with PCI, absolute difference: 0.7%, upper bound of the 97.5% CI: 4.0%; p= 0.02 for non-inferiority). There was no significant difference in death from any cause (5.9% with CABG vs 8.2% with PCI; p= 0.11), myocardial infarction (8.3% with CABG vs 8.0% with PCI, p= 0.64) or stroke (2.9% with CABG vs 2.3% with PCI; p= 0.37). Ischemia-driven revascularization was higher with PCI (12.6% vs 7.5%; p

Lancet 2016;388:2743-52Background: PCI was commonly used for the management of patients with left main coronary artery disease and favorable pathology (i.e., absence of complex lesions). This was recommended by the guidelines at the time and based mainly on the prespecified subgroup of 705 patients with left main disease in the SYNTAX trial. The NOBLE trial sought to more rigorously test the hypothesis that PCI with drug eluting stents was non-inferior to CABG in patients with unprotected left main coronary artery stenosis.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support our work, consider becoming a free or paid subscriber.Patients: Inclusion criteria for study enrollment were stable angina pectoris, unstable angina, or acute coronary syndrome with a left main lesion with visually assessed stenosis diameter >/= 50% or fractional flow reserve I. The number of target lesions was 2 in both groups. The average SYNTAX score was 22.5 (for reference, it was 28.7 in the SYNTAX trial). The percentage of patients with stable angina was 82% and acute coronary syndrome was 18%. Patients were enrolled from 36 different centers but 5 centers contributed 42% of them. A screening log from these 5 centers was presented in the main paper. For these centers, the enrolled/screened ratio was 52%. The most common reasons for exclusion were unsuitable coronary anatomy for PCI.Procedures: Patients were assigned 1:1 to undergo PCI with drug eluting stents or CABG. After treatment of 73 patients with PCI, the Biolimus-eluting stent became the recommended study stent. Randomization was stratified by sex, the presence of a distal left main bifurcation lesion, and diabetes.The intent was to achieve complete revascularization of all vessels with significant lesions. The techniques for CABG and PCI as well as post-treatment medicines were chosen based on local practice but included 75-150 mg of aspirin lifelong. In both groups, patients with acute coronary syndrome received 75 mg of clopidogrel daily for 12 months. All patients in the PCI group also received 75 mg clopidogrel daily for 12 months and prasugrel or ticagrelor could be substituted at the discretion of the PCI operator.Endpoints: The primary endpoint was a composite of death from any cause, non-procedural myocardial infarction, repeat revascularization, or stroke.Analysis was performed based on the intention-to-treat principle. The primary analysis was a non-inferiority analysis. The main hypothesis tested was non-inferiority of PCI to CABG, assessed as the upper limit of the 95% CI of the hazard ratio (HR) of PCI to CABG, not exceeding 1.35 at median 3 years of follow-up. It should be noted that the sample size calculation for NOBLE was based on 1 year event estimates from the SYNTAX trial that were extrapolated to 2 years. The sample size of 1,200 patients came from the original hypothesis test of non-inferiority corresponding to a total of 275 events at median 2 years of follow-up. However, due to slow accrual of events, assessment of the primary endpoint could not be reached within the limit of the study and so the primary endpoint assessment was pushed back to 3 years of follow-up. Despite this, the prespecified event total (275 events) was not reached.Results: 1,201 patients were enrolled, which included 598 in the PCI group and 603 in the CABG group; however, only 592 patients in each group were entered into the final intention-to-treat analysis. Compared to CABG, PCI increased the primary composite endpoint (28% vs 18%; HR 1.51; 95% CI 1.13-2.00). Since the upper bound of the 95% CI was >1.35, PCI did not pass the test for non-inferiority. The primary outcome was driven mainly by differences in non-procedural MI (6% vs 2%; HR 2.87; 1.40-5.89) and repeat revascularization (15% vs 10%; HR 1.50; 1.04-2.17), which favored the CABG group. There was no difference in all-cause mortality (11% vs 9%; HR 1.08; 0.67-1.74) or its sub-component of cardiovascular mortality (3% vs 3%; HR 0.92; 0.44-1.90). The outcome of stroke was numerically higher with PCI but the difference was not statistically significant (5% vs 2%; HR 2.20; 0.91-5.36). When examining the Kaplan-Meier curves for the primary outcome, the curves start to diverge at 1 year.PCI was associated with significantly lower 30 day morbidity compared to CABG exemplified by 3 outcomes: duration of index treatment admission (2 vs 9 days; p

N Engl J Med 2012;367:2375-2384Background: The first large trial to compare PCI vs CABG was SYNTAX. In the subgroup of patients with diabetes, which made up approximately 25% of the trial population, PCI was associated with a higher rate of adverse events compared to CABG, primarily driven by higher rates of repeat revascularization in the PCI group.The Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease (FREEDOM) trial sought to assess the optimal revascularization strategy for patients with diabetes and multivessel coronary artery disease.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support our work, consider becoming a free or paid subscriber.Patients: Eligible patients had diabetes and multivessel coronary artery disease defined as a stenosis of 70% or more in two or more major coronary arteries supplying at least two separate territories.Patients with left main stenosis of 50% or more were excluded as well as patients with severe congestive heart failure, prior CABG or valve surgery, stroke within 6 months, significant bleeding within 6 months, 2 or more chronic total occlusions in major coronary territories that are targets for revascularization, and patients with STEMI within 72 hours.Baseline characteristics: The trial randomized 1,900 patients – 953 randomized to PCI and 947 to CABG.The average age of patients was 63 years and 71% were men. The average HbA1c was 7.8 and 32% were using insulin. Approximately 26% had prior myocardial infarction and 16% were current smokers. The average left ventricular ejection fraction was 66%.Approximately 83% had three vessel disease and 6% of the lesions were classified as chronic total occlusions. The SYNTAX score was low (22 or less) in 35% of the patients, intermediate (23 - 32) in 45% and high (33 or more) in 20%.Procedures: Patients were randomized in a 1:1 ratio to undergo CABG or PCI using drug-eluting stents. The use of arterial conduits was encouraged for patients undergoing CABG.Dual antiplatelet therapy with aspirin and clopidogrel was recommended for at least 12 months following PCI.Endpoints: The primary endpoint was a composite of death from any cause, nonfatal myocardial infarction, and nonfatal stroke. Secondary analysis was performed based on the SYNTAX score and study center location; north America vs not.Analysis was performed based on the intention-to-treat principle. The estimated sample size was 1,900 patients to be followed up for at least 2 years. This sample size would provide 80% power to detect a 27% relative risk reduction in one treatment group based on an estimated event rate of 21.5% in the arm with higher event rate.It's important to note that the initial sample size was 2,400 patients but this was amended twice due to slow recruitment.Authors performed 3 interim analyses and therefore, the p value to indicate statistical significance for the primary outcome was adjusted to be 0.044.Results: Among 32,966 patients who were screened for inclusion, 3,309 (10%) were found eligible. Among eligible patients, 1,900 consented to the trial and were randomized. The breakdown for excluding patients was not provided. The median follow up time was 3.8 years (interquartile range: 2.5 - 4.9). In the PCI arm, the average number of lesions stented per patient was 3.5 and 34% underwent a staged procedure. In the CABG arm, the average number of vessels grafted was 2.9 and 94% had a left internal mammary artery graft.At 5-years, the primary outcome was lower in the CABG arm (18.7% vs 26.6%, absolute difference 7.9%, 95% CI: 3.3 – 12.5; p= 0.005). All-cause death was lower with CABG (10.9% vs 16.3%; p= 0.049) as well as myocardial infarction (6.0% vs 13.9%; p< 0.001). When examining the Kaplan-Meier curves for the primary endpoint as well as death (figure 1 of the manuscript), the curves start to diverge, in favor of surgery, at approximately 2-years of follow up.Stroke was higher with CABG (5.2% vs 2.4%; p= 0.03). Excess stroke in the CABG arm was largely within 30-days after the procedure (1.8% vs 0.3%).Major bleeding within 30-days after revascularization was not significantly different between both treatment groups (3.6% with CABG vs 2.4% with PCI; p= 0.13). Acute renal failure requiring dialysis within 30-days after revascularization was higher with CABG (0.8% vs 0.1%; p= 0.02).There were no significant subgroup interactions that included the SYNTAX score, sex, 2- or 3-vessel disease and study center location; north America vs not.Conclusion: In patients with diabetes and multi-vessel stable coronary artery disease, CABG was superior to PCI in reducing the primary endpoint that consisted of death from any cause, nonfatal myocardial infarction, and nonfatal stroke with a number need to treat (NNT) of approximately 13 patients over an average follow-up period of 3.8 years. All-cause death and myocardial infraction were significantly lower with CABG with a NNT of approximately 19 and 13, respectively. Stroke was higher with CABG with a number needed to harm (NNH) of 36 patients. CABG also increased the risk of acute renal failure requiring dialysis within 30-days after revascularization with a NNH of approximately 143.A key difference between this trial and the early CABG trials is the frequent use of internal mammary grafts in FREEDOM (94% vs 10%). Internal mammary grafts are resistant to atherosclerosis and have high patency rates. One possible explanation for the divergent results between this trial and SYNTAX, which also used arterial grafts frequently, is the follow up time. In SYNTAX, patients were followed for 1 year while FREEDOM followed patients up to 5 years and the curves for the primary outcome and death favoring CABG started to diverge at approximately 2 years.When deciding between CABG and PCI for patients meeting the trial's eligibility criteria, it's important to consider the early risks associated with surgery, with the benefits of CABG becoming more apparent after 2 years. Cardiology Trial's Substack is a reader-supported publication. 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On this month's EM Quick Hits podcast: Kevin Wasko on post-tonsillectomy hemorrhage management, Brit Long on assessment and management of post-CABG surgical incision infections, Anand Swaminathan on evidence, pitfalls and tips on using Bougies, Leah Flannigan on when to suspect vascular injury in patients with low energy mechanism pelvic fractures, Andrew Petrosoniak on debriefing after cases: why, when and how... Do you learn a lot from EM Cases? Please consider a donation to ensure EM Cases continues to provide you high quality Free Open Access Medical Education here: https://emergencymedicinecases.com/donation/

N Engl J Med 2009;360:961-972Background: After its introduction in 1968, the use of coronary artery bypass grafting (CABG) in patients with coronary artery disease grew rapidly. Although early trial results were mixed (see the Veterans Administration Cooperative study, the European Coronary Surgery Study and the CASS study), advancements in surgical techniques and the use of arterial conduits improved survival and reduced graft occlusion rates. In 1977, percutaneous coronary intervention (PCI) was introduced, and subsequent improvements in PCI techniques and stents have led to fewer complications and better stent patency. Large trials comparing CABG to PCI using drug-eluting stents were lacking.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.The Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial sought to assess the optimal revascularization strategy for patients with left main or three-vessel coronary artery disease.Patients: Eligible patients had three-vessel or left main coronary artery disease. Patients had to have 50% or more stenosis in the target vessels and either chest pain or evidence of myocardial ischemia. Exclusion criteria were previous PCI or CABG, acute myocardial infarction or the need for concomitant cardiac surgery.Baseline characteristics: The trial randomized 1,800 patients – 903 randomized to PCI and 897 to CABG.The average age of patients was 65 years and 78% were men. The average body mass index was 28 kg/m2. Approximately 67% had hypertension, 78% had hyperlipidemia, 25% had diabetes, 33% had prior myocardial infarction, 5% had congestive heart failure, and 20% were current smokers.The number of target lesions was approximately 4 in both groups. The SYNTAX score was 28.4 in the PCI group and 29.1 in the CABG group.Note to readers: The SYNTAX score is an anatomical score to grade the complexity of coronary artery disease with higher scores indicating more complex disease. A score of 22 or less is considered low whereas a score of 33 or more is considered high (this scoring was a prespecified secondary endpoint). Procedures: Patients were assigned in a 1:1 ratio to undergo CABG or PCI using Taxus Express paclitaxel-eluting stents (drug-eluting stent). Randomization was stratified by the presence or absence of left main disease and diabetes.The intent was to achieve complete revascularization in all coronary arteries of at least 1.5 mm diameter with 50% or more stenosis. The techniques for CABG and PCI and post procedural medications were chosen based on local practices.Endpoints: The primary endpoint was a composite of death from any cause, stroke, myocardial infarction, or repeat revascularization up to 12 months after randomization.Analysis was performed based on the intention-to-treat principle. The primary analysis was a non-inferiority analysis. The estimated sample size was 1800 patients assuming 13.2% event rate in the CABG group, 14.0% in the PCI group and 6.6% absolute risk difference non-inferiority margin. This sample size would provide 96% power at 5% one-sided alpha.Results: Revascularization was complete in 56.7% of the patients in the PCI group and 63.2% in the CABG group. In the CABG group, one or more arterial grafts were used in 97.3% of the patients. In the PCI group, the average number of stents implanted per patient was more than four.At 12 months, the primary outcome was lower in the CABG group (12.4% vs 17.8%, RR with PCI: 1.44, 95% CI: 1.15 – 1.81; p= 0.002). The absolute difference was 5.4% with an upper bounds of the 95% CI of 8.3%; thus not meeting non-inferiority. Stroke was lower with PCI (0.6% vs 2.2%; p= 0.003) while repeat revascularization was lower with CABG (5.9% vs 13.5%; p< 0.001). There was no significant difference in death from any cause (4.4% with PCI vs 3.5% with CABG; p= 0.37) or myocardial infarction (4.8% with PCI vs 3.3% with CABG; p= 0.11).There was a significant interaction based on the SYNTAX score where patients with high SYNTAX scores (>/=33) had significant benefit with CABG while patients with low or intermediate SYNTAX scores did not (14.7% with CABG vs 13.6% with PCI for low SYNTAX score, 12.0% with CABG vs 16.7% with PCI for intermediate SYNTAX score, and 10.9% with CABG vs 23.4% with PCI for high SYNTAX score; p for interaction= 0.01).In the subgroup of patients with left main disease, the rate of the primary outcome at 12 months was not significantly different between both treatment groups (13.7% with CABG vs 15.8% with PCI; p= 0.44). In patients with three-vessel but no left main disease, the primary outcome was significantly higher in the PCI group (19.2% vs 11.5%; p< 0.001).Stent thrombosis was 3.2% in the PCI group and graft occlusion was 3.1% in the CABG group.Conclusion: In patients with stable three-vessel or left main coronary artery disease, PCI did not meet non-inferiority compared to CABG in reducing the composite endpoint of death from any cause, stroke, myocardial infarction, or repeat revascularization over 12 months of follow up. The number of patients needed to treat with CABG to prevent one primary endpoint was approximately 19 patients, which was mainly accounted for by repeat revascularization. There was no significant difference in death or myocardial infarction and stroke was higher in the CABG group.The subgroup analysis based on SYNTAX score demonstrated a strong signal that CABG is more effective than PCI in patients with complex coronary artery disease. In patients with stable coronary artery disease, meeting the inclusion criteria of this trial, the risk of repeat revascularization with PCI should be carefully weighed against the increased stroke risk and invasiveness of CABG. Considerations regarding patient selection are crucial. It is reasonable to anticipate that less robust patients will have higher morbidity with CABG versus PCI.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber. Get full access to Cardiology Trial's Substack at cardiologytrials.substack.com/subscribe

N Engl J Med 2023;389:2319-2330Background: Percutaneous coronary intervention (PCI) does not reduce mortality or myocardial infarction as seen in COURAGE, FAME 2, ISCHEMIA and ISCHEMIA-CKD. However, unblinded studies have indicated that revascularization may improve symptoms, which is a key factor in driving PCI decisions for many patients. ORBITA was the first blinded, placebo-controlled trial of PCI for stable angina and found no significant improvement in exercise time with PCI. The trial had a high use of anti-anginal medications, with an average of 3 medications per patient  pre-randomization. However, this level of medication use is not always achievable in clinical practice due to side effects and challenges with adherence.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.The ORBITA-2 trial sought to test the hypothesis that PCI improves symptoms in patients with stable angina who are not receiving background antianginal medications.Patients: Eligible patients had angina or angina equivalent, severe coronary stenosis of 70% or more in at least one coronary artery and evidence of ischemia on non-invasive testing or by invasive pressure wire assessment.Main exclusion criteria were acute coronary syndrome within 6 months, previous CABG, left main disease, chronic total occlusion of target vessel, and left ventricular ejection fraction of 35% or less.Baseline characteristics: The trial randomized 301 patients – 151 randomized to PCI and 150 to placebo PCI.The average age of patients was 64 years and 79% were men. Approximately 63% had hypertension, 28% had diabetes, 72% had hyperlipidemia, and 62% were current or previous smokers. Left ventricular systolic function was normal in 96% of the patients.Angina class based on the Canadian Cardiovascular Society (CCS) angina grade was 2 in 58% of the patients and 3 in 39%. Approximately 80% had single vessel disease, 17% had 2-vessel disease and 2% had 3-vessel disease. Left anterior descending coronary artery was the target vessel in 55% of the patients.Procedures: Patients initially underwent coronary angiogram and invasive physiologic assessment was performed in each vessel with 50% or more stenosis. Patients underwent the coronary angiography while wearing headphones with music playing for auditory isolation throughout the procedure. Patients who had evidence of ischemia in at least one territory were then randomized in a 1:1 ratio to PCI or placebo PCI. Patients were sedated until they were unresponsive to verbal and tactile stimuli. In the PCI group, all target vessels were treated during the index procedure. Patients in the placebo group did not receive intervention and were kept sedated for at least 15 minutes after randomization.The recovery room staff and all subsequent medical providers were unaware of the treatment assignments. The operator and research staff who were present during the randomization procedure had no further contact with the patients.Anti-anginal medications were stopped at enrollment. Antihypertensive medications that has antianginal properties were replaced with different agents.Patients were followed up for 12 weeks during which they reported daily angina symptoms using a smart phone application. New anti-anginal medications or increase in the dose of anti-anginal medications were also tracked. At the end of the 12 weeks, patients completed symptom and quality-of-life questionnaires, had an assessment of CCS class, and underwent a treadmill exercise test and dobutamine stress echocardiography. After all of these were completed, patients and medical staff were unblinded.Endpoints: The primary endpoint was an angina symptom score calculated based on the number of angina episodes that a patient reported on a given day and the number of units of antianginal medication prescribed on that day. In this score, each episode of angina on a particular day counts as 1 point for a maximum of 6 points per day (0 points given to no angina), and each unit of anti-anginal medications counts as 7 points (0 points given for no antianginal medications prescribed that day). In supplement table 3, authors provided what counted as one unit of anti-anginal medications. For example, atenolol 25 mg counted as 1 unit and amlodipine 2.5 mg counted as one unit.Secondary endpoints included frequency of angina, use of ant-anginal medications, exercise time on treadmill test and symptoms questionnaires.Analysis was performed based on the intention-to-treat principle. The estimated sample size to achieve 80% power at 0.05 alpha was 284 patients. This is based on assumed standard deviation of 6 angina symptom score units and a difference of 2 units between PCI and placebo.Results: Data were available on 99.7% of the total patient-days.Compared to placebo, PCI reduced the mean angina symptom score (2.9 vs 5.6, OR: 2.2, 95% CI: 1.4 - 3.5; p

Reason for Visit: The patient is a 76-year-old Hispanic referred to the ambulatory care pharmacist for dyslipidemia management.  The patient has a remote history of an MI (15 years ago) but states he is unable to take statins. Guest Authors: Mayela Warner, PharmD and Maricar Conson, PharmD, BCPS Expert Panelists: Sara Wettergreen, PharmD, BCACP, BC-ADM and Tomasz Jurga, PharmD, BCPS, BCACP, BCCP, CDCES Music by Good Talk

Dr. Gianluca Torregrossa, a cardiothoracic surgeon at Lankenau Heart Institute in Philadelphia, discusses Off-pump CABG, a method developed to perform the surgery without stopping the heart, has not proven superior to traditional methods due to complications like stroke, which can occur when manipulating the aorta. Dr. Torregrossa highlights the Enclose® II device by Peters Surgical and shares his personal experience using the device in over 700 surgeries. Dr. Torregrossa stresses the importance of adopting new technologies like Enclose® II to improve surgical outcomes and ensure patients return to their normal lives post-surgery. Dr TORREGROSSA was graduated from the University of Padua Itlay in 2006. In 2011, he was a part of the team who implanted the first total artificial Heart in Italy. Few years later he was appointed Associate director of Robotic Heart Surgery at Mount Sinai St Luke (NYC), then joined the Cardiac Robotic and Minimally Invasive Division of Surgery at University of Chicago and since 2021 he is the Director of the Robotic Coronary Program in Main Health Hospital Philadelphia. Dr Torregrossa is the author of more than 80 publications in peer-reviewed journals, including 1 book. He serves as reviewer for several journals, and his current h index is 12. Finally, he speaks 4 languages and crossed the Sahara twice on his motorbike.  Visit his LinkedIn profile: Gianluca Torregrossa | LinkedIn   About Behind the OR Behind the OR is the official podcast channel by Peters Surgical. Here, we invite you to step into the world of surgery, where we uncover what happens behind the closed doors of the operating room and beyond. Each episode features in-depth conversations with expert surgeons, providing insights into the latest surgical techniques, innovations, and the daily lives of those who dedicate themselves to saving lives. Founded in 1926, Peters Surgical is a French company with a global presence in over 90 countries. As a reference group for surgical practices worldwide, we are dedicated to improving surgical outcomes through innovative medical devices, including surgical sutures, hemostatic clips, and surgical glue. Our expertise lies in designing, manufacturing, and distributing these devices.  Visit our website here : https://peters-surgical.com/

This week on The Beat, Editor in Chief Joel Dunning speaks with Ahmed Abbas about the recent 2024 Warith International Cardiology and Cardiothoracic Surgery Conference he organized at the University of Warith Al-Anbiyaa in Karbala, Iraq. They discuss the quality of heart surgery in Iraq, how many available facilities there are, how cardiothoracic surgery differs in Iraq from other countries, and the challenges of performing cardiothoracic surgery in Iraq. Additionally, Joel spoke with medical students to gain their perspectives on studying medicine in Iraq and their aspirations for the future.  He also discusses several JANS items including VATS thoracoscopic S1 segmentectomy, restoring discarded porcine lungs, emergent coronary revascularization with PCI and CABG, heart transplant for a patient with left superior vena cava, pathways to cardiothoracic surgery, defining resectability, and outcomes following heart valve surgery in patients with infective endocarditis.  In addition, Joel discusses a trans-subxiphoid robotic-assisted thymectomy, Apple Vision Pro spatial computing for endoscopic mitral valve, and the Aswan technique for extended septal myectomy. Before closing, Joel discusses upcoming events in CT surgery.  JANS Items Mentioned 1.) VATS Thoracoscopic S1 Segmentectomy, Right Upper Lobe: Alternative Posterior Approach 2.) Restoring Discarded Porcine Lungs by Ex Vivo Removal of Neutrophil Extracellular Traps  3.) Emergent Coronary Revascularization With PCI and CABG in Patients Receiving Extracorporeal Cardiopulmonary Resuscitation  4.) Heart Transplant for a Patient With Left Superior Vena Cava—Case Report and Surgical Technique 5.) Pathway to Cardiothoracic Surgery: A Primer for Aspiring Students  6.) Defining Resectability: When Do You Try to Take It Out? 7.) Outcomes Following Heart Valve Surgery in Patients With Infective Endocarditis and Preoperative Septic Cerebral Embolism  CTSNet Content Mentioned 1.) The Aswan Technique for Extended Septal Myectomy  2.) Apple Vision Pro Spatial Computing for Endoscopic Mitral Valve and VSD Surgery 3.) Trans-Subxiphoid Robotic-Assisted Thymectomy  Other Items Mentioned CTSNet Events Calendar Disclaimer The information and views presented on CTSNet.org represent the views of the authors and contributors of the material and not of CTSNet. Please review our full disclaimer page here.

N Engl J Med 1999;341:70-76Background: Percutaneous transluminal coronary angioplasty (PTCA) was widely used in the 1990s for its potential benefit in improving symptoms in patients with stable coronary artery disease, as discussed in the ACME and RITA-2 trials. However, the RITA-2 trial showed that PTCA worsened hard outcomes, and ACME was underpowered for such comparison. At the same time, trials demonstrating the ability of statin drugs to reduce cardiovascular events and improve survival had led to an increase in use of the lipid-lowering drugs. Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.The Atorvastatin versus Revascularization Treatment Investigators sought to test the unique hypothesis that atorvastatin is superior to angioplasty in reducing ischemic events in patients with stable coronary artery disease. *It is important to note that the historical trials of CABG versus medical therapy that led to the widespread adoption of coronary revascularization, in general, were completed prior to the adoption of statin therapy. Thus a weakness of the CABG literature, which we have addressed in detail in prior posts and podcasts, is that the efficacy of CABG is inconsistent at best and medical therapy, at the time, was very limited. This makes this study of atorvastatin versus angioplasty of particular interest.Patients: Eligible patients had stenosis of 50% or more in one or two coronary arteries and had been recommended for treatment with percutaneous revascularization. The patients were asymptomatic or had Canadian Cardiovascular Society (CCS) class I or II angina. LDL levels had to be least 115 mg/dL and triglyceride levels of 500 mg/dL or less.Patients were excluded if they had left main coronary artery disease, 3-vessel disease, unstable angina or myocardial infarction within the previous 2 weeks, or if the ejection fraction was

Abdullah Al-Abcha, MD, social media editor of JACC: Cardiovascular Interventions, and Luke Dawson, MBBS, MPH, discuss a recently published original research paper that aimed to assess the interactive effects of coronary complexity on PCI and CABG outcomes and identify the optimal threshold where PCI can be considered a reasonable option.

N Engl J Med 1992;326:10-16Background: Revascularization with coronary artery bypass surgery improves symptoms in patients with chronic stable angina as seen in the European Coronary Surgery Study. Percutaneous transluminal coronary angioplasty (PTCA) is less invasive compared to surgery and is associated with less mortality and morbidity. Consequently, its use increased significantly in the late 1980s and early 1990s, driven by its perceived benefits over medical therapy alone due to the ability of PTCA to reduce coronary artery luminal stenosis.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.The Angioplasty Compared to Medicine (ACME) study sought to test the hypothesis that PTCA improves symptoms in patients with single vessel sable coronary artery disease.Patients: Eligible patients were recruited from Veterans Affairs centers. Patients had to have 70 – 99% stenosis in the proximal two thirds of one major epicardial coronary artery plus one of the following: stable angina pectoris, very positive exercise-tolerance test (ST-segment depression ≥3 mm) or a myocardial infarction within the past 3 months.Baseline characteristics: The study screened 9,573 patients and among them only 212 (2.2%) were enrolled – 107 randomized to medical therapy and 105 to PTCA. The reasons for patients' exclusion were provided in table 1 of the manuscript. Some key exclusion criteria were previous CABG, unstable angina, prior PTCA, 3-vessel disease or lesions not suitable for PTCA.The average age of enrolled patients was 63 years. Approximately 30% had prior myocardial infarction, 53% had hypertension, 18% had diabetes, 1% had congestive heart failure, and 31% were current smokers. There were more employed participants in the PTCA arm 42% vs 29%. The average systolic blood pressure was 136 mm Hg. The average total cholesterol was 230 mg/dl.The average duration participants did on the treadmill was 8.8 minutes. Approximately 38% had LAD disease, 25% had LCx disease, and 37% had RCA disease.Procedures: All patients were admitted to the hospital. Anti-anginal medications were stopped for at least 24 hours and exercise stress test that included thallium Scintigraphy was performed. The test was considered positive if there was horizontal or down-sloping ST-segment depression ≥ 1.0 mm in one or more leads measured 80 msec after the J point that occurred during or after treadmill exercise testing. Patients who had angina during the test but did not meet the above criteria could be included if there was evidence on thallium scanning of a reversible defect in the area corresponding to the index lesion. If the test showed ischemia, patients were then assigned to PTCA or medical therapy.All patients received aspirin 325 mg/day. Patients in the medical arm received one or combination of the following: nitrates, beta-blockers or calcium channel blockers. Patients in the PTCA arm received calcium channel blockers before and for one month after the procedure, and nitroglycerin during and for 12 hours after the procedure.Patients were followed monthly. Patients were admitted to the hospital 6 months after randomization, for repeat exercise testing and coronary angiogram. For patients in the medical arm, this exercise testing was performed while they continued their anti-anginal medications. In contrast, patients in the PTCA arm stopped their anti-anginal medications for at least 24 hours before the test.Endpoints: The primary end points were changes in exercise tolerance, angina attacks and the use of nitroglycerin. Change in the degree of stenosis in the index lesion was measured as a secondary endpoint.Analysis was performed based on the intention-to-treat principle. The sample size to achieve 95% power at an alpha level of 0.05 was 192. This was based on the assumption that PTCA would increase exercise duration by 1-minute compared to medical therapy. To account for potential loss to follow-up, the recruitment goal was set at 200 patients.Results: Among the 105 patients assigned to PTCA, 95% underwent the procedure, and among them, the procedure was considered successful in 82%. Successful PTCA was defined >20% decrease in percent stenosis of all lesions in which dilation was attempted. Among the 107 patients assigned to medical therapy, 10% underwent PTCA.The mean duration from randomization to follow-up exercise testing was approximately 7 months. PTCA led to greater increase in exercise time compared to medical therapy alone (2.1 minutes vs 0.5 minutes; p< 0.0001) as well as time to onset of angina (2.6 minutes vs 0.8 minutes; p

N Engl J Med 2011;364:1607-1616Background: The three pivotal trials of coronary artery bypass graft surgery (CABG) we previously reviewed, largely included patients with normal left ventricular function. Observational studies suggested that CABG improved survival over medical therapy in patients with coronary artery disease and systolic heart failure.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.The Surgical Treatment for Ischemic Heart Failure (STICH) trial sought to test the hypothesis that CABG reduces mortality in patients with coronary artery disease and left ventricular systolic dysfunction.Of note, the STICH had two hypotheses: medical therapy vs CABG (hypothesis 1) or CABG vs CABG plus surgical ventricular reconstruction (hypothesis 2) “patients in all arms received medical therapy according to the guidelines at that time”. In this review we focus on hypothesis 1. We are also reporting the 5-year results of STICH since that was the primary intended follow up time.Patients: Eligible patients had coronary artery disease that was amenable to surgery and left ventricular ejection fraction of 35% or less. Patients were excluded if they had recent myocardial infarction, cardiogenic shock within 72 hours of randomization, life expectancy

Lancet 1994;344(8922):563-570Background: Several randomized trials have assessed the benefits of coronary artery bypass graft surgery (CABG) in patients with chronic stable angina. We reviewed three major trials in this area: The Veterans Administration Cooperative Study, the European Coronary Surgery Study, and the CASS study. These trials yielded divergent results, likely due to differences in patients included and surgical conduits used.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.The aim of this study was to conduct a patient-level meta-analysis of these three major trials, plus four additional smaller trials, to compare the long-term effects, at 10 years, of coronary artery bypass surgery versus medical therapy.Note to readers: We are including this meta-analysis among our reviews since it's frequently referenced when discussing the benefits of coronary artery bypass surgery.Patients: Patients were included from 7 trials of coronary artery bypass surgery in chronic stable angina. Patients entered the trials between 1972 and 1984. Left ventricular systolic function was considered abnormal if the ejection fraction was < 50%. Coronary artery was considered to be diseased if it had a stenosis > 50%. Angiographic data were available from all trials except one of the four smaller trials.Baseline characteristics: The study included a total of 2,649 patients; 1,324 patients were assigned to receive surgery and 1,325 were assigned to receive medical therapy. The three major trials contributed 2,233 (84.3%) patients while the four smaller trials combined contributed 416 (15.7%) patients. The average age of patients was 51 years with 97% being men. The mean ejection fraction was 59%. About 60% had prior myocardial infarction, 26% had hypertension, 4% had heart failure, 10% had diabetes, and 84% had smoking history.Approximately 10% had single vessel disease, 32% had two-vessel disease, and 51% had three-vessel disease. Left main disease was present in about 7% of the patients, and about 59% had proximal left anterior descending artery disease.Procedures: Individual patients' data were collected on a standardized form. Patients in the trials were randomly assigned to coronary artery bypass surgery or medical therapy.Endpoints: The primary end point was all-cause death. The statistical analysis was performed based on the intention-to-treat principle, irrespective of crossover. Authors also sought to assess the interaction of treatments based on the extent of coronary artery disease, left ventricular dysfunction and some comorbid conditions.Results: The authors reported mortality at 5, 7 and 10 years. In this review, we will focus on the 10 years results as this was the intention of the study and most patients had 10-year follow-up data available. Of those assigned to surgery, 93.7% underwent the procedure, while 37.4% of patients initially assigned to medical therapy ended up having surgery. Among the patients assigned to surgery, the 30-day operative mortality was 3.2%. The mean number of grafts used was 2.4 and 9.9% of the patients received an internal mammary artery graft.Antiplatelets were used by 18.8% of the patients in the medical arm and 25.5% in the surgical arm.CABG significantly reduced mortality compared to medical therapy alone (26.4% vs 30.5%, OR: 0.83, 95% CI: 0.70 – 0.98; p= 0.03). CABG reduced mortality in patients with left main disease (OR: 0.67; p= 0.24 “this is insignificant due to small sample size”) and in patients with three vessel disease (OR: 0.76; p=0.02). CABG also reduced mortality in patients with one or two vessel disease if they had left anterior descending artery disease (OR and p value for 10-years were not provided). Absolute values were not provided for any of these subgroups at 10-years.Authors reported no significant interactions based on history of hypertension, smoking or prior myocardial infarction (no event rate or results of interaction testing were provided for these groups). At 5-years, patients with left ventricular dysfunction derived similar benefit with surgery compared to patients with normal left ventricular function (p for interaction= 0.90).Conclusion: In patients with stable angina pectoris and > 50% stenosis in at least one of the major coronary arteries, coronary artery bypass surgery compared to medical therapy alone reduced death at 10-years with a number need to treat of approximately 24 patients. The benefit was seen in patients with left main disease, three vessel disease and patients with left anterior descending artery disease. No benefit was seen in patients with one or two vessel disease if they did not have left anterior descending artery disease.Of note, unlike most current meta-analyses that rely on trial-level data, this type of meta-analysis provides significantly higher level of evidence as it uses patient-level data. This method allows for the categorization of patients based on uniform definitions, the ability to reperform the analysis and helps address some limitations in previous trials. For example, the current study used an intention-to-treat analysis, while the Veterans Administration Cooperative study used a "modified intention-to-treat analysis."Despite these strengths, some limitations from the original trials carry over to this study such as the small number of patients with left main disease (about 7% of study population) and the infrequent use of internal mammary artery (about 10%). Furthermore, the advancement in both medical therapies as well as surgical techniques since the publication of this study, limit its external validity in the current era.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber. Get full access to Cardiology Trial's Substack at cardiologytrials.substack.com/subscribe

CardioNerds Dan Ambinder and Dr. Devesh Rai join cardiology fellows and National Lipid Association lipid scholars Dr. Oby Ibe from Temple University and Dr. Elizabeth Epstein from Scripps Clinic. They discuss a case involving a patient with elevated Lp(a). Dr. Jessica Pena provides expert commentary. Drs. Oby Ibe and Elizabeth Epstein drafted notes. CardioNerds Intern Christiana Dangas engineered episode audio. This episode is part of a case reports series developed in collaboration with the National Lipid Association and their Lipid Scholarship Program, with mentorship from Dr. Daniel Soffer and Dr. Eugenia Gianos. This is a 63-year-old man with hypertension, hyperlipidemia, and active tobacco smoking who presented with acute dyspnea. He was tachycardic but otherwise initially hemodynamically stable. The physical exam demonstrated warm extremities with no murmurs or peripheral edema. Chest X-ray revealed diffuse pulmonary edema, and the ECG showed sinus tachycardia with T-wave inversions in the inferior leads. A bedside echocardiogram revealed a flail anterior mitral valve leaflet. The patient was taken for cardiac catheterization that revealed nonobstructive mid-RCA atheroma with a distal RCA occlusion, which was felt to reflect embolic occlusion from recanalized plaque. PCI was not performed. Right heart catheterization then demonstrated a low cardiac index as well as elevated PCWP and PA pressures. An intra-aortic balloon pump was placed at that time. A TEE was performed soon after which showed the posteromedial papillary muscle was ruptured with flail segments of the anterior mitral leaflet as well as severe posteriorly directed mitral regurgitation. The patient ultimately underwent a successful tissue mitral valve replacement and CABG. US Cardiology Review is now the official journal of CardioNerds! Submit your manuscript here. CardioNerds Case Reports PageCardioNerds Episode PageCardioNerds AcademyCardionerds Healy Honor Roll CardioNerds Journal ClubSubscribe to The Heartbeat Newsletter!Check out CardioNerds SWAG!Become a CardioNerds Patron! Pearls - Little (a), Big Deal – National Lipid Association You are never too young to see a preventive cardiologist! The field of preventive cardiology is shifting focus towards the identification of early upstream risk and intervention before the development of clinical ASCVD (1,5). Patients who have a strong family history of cardiovascular disease, a personal history of CVD at an early age, multiple risk factors, or genetic disorders such as familial hypercholesterolemia especially benefit from early cardiovascular risk assessment and reduction. Female-specific risk factors to incorporate into a young woman's cardiovascular risk assessment include polycystic ovarian syndrome, hormone contraceptive use, early menarche (age 5 pregnancies), early menopause (age

Circulation 68, No. 5, 939-950, 1983Background  Coronary artery bypass surgery (CABG) had grown in popularity through the 1970s and 1980s. By 1981, approximately 159,000 bypass surgeries had been done.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support our work, consider becoming a free or paid subscriber.The goal of the CASS trial was to rigorously evaluate the effect of surgical vs medical therapy on total mortality in well-defined subsets of patients with coronary artery disease.Patients Eligible patients had to be 65 years of age or below and have angina that was Canadian Cardiovascular Society class I or II with or without a history of myocardial infarction, or had to have a well-documented MI more than 3 weeks before randomization. Clinical criteria for exclusion were prior CABG, unstable or progressive angina, angina more severe than class II (angina occurring after climbing one flight of stairs or walking two blocks is class III), congestive heart failure (New York Heart Association class III or IV), a coexisting illness that would increase the likelihood of death within 5 years, and a variety of practical exclusions that might limit active participation during follow-up.Angiographic requirements for participation in the trial included the presence of significant operable coronary artery disease, defined as either 70% or greater reduction in the diameter of the right, left anterior descending, or left circumflex coronary artery, or 50% or greater reduction in the diameter of the left main coronary artery. Patients with 70% or greater luminal diameter reduction of the left main were excluded. Also excluded were patients with LVEF (measured by left ventriculography) of less than 35% or those patients who required valve surgery or LV aneurysm repair.Baseline Characteristics There were 390 patients randomized in both the surgical and medical arm. The mean age was 51 years; 90% were males and 98% were White. Approximately 60% had previous MI, 30% had hypertension and only 3% had congestive heart failure. About 40% were smokers.Angiographic criteria were well matched—27% had one-vessel disease, 38% had two-vessel disease, and about a third had three-vessel disease. Nearly a third of patients in both groups had proximal LAD disease. The LVEF was more than 50% in 73-74% of patients in both groups. The LVEF was less than 50% in a fifth of patients in both arms.Procedures CASS authors were quite clear in the screening and randomization process. Slightly more than 16,600 patients were screened for participation in the trial at 11 centers. Figure 1 in the manuscript shows the reasons for exclusion, which included normal or minimal coronary disease (28%), Class 3 or 4 angina (36%), and left main disease more than 70%n (1.5%). Other exclusions totaled 16%.Ultimately there were 2099 patients eligible to be randomized, however, 1319 patients were not included in the trial due to physician preference.Randomization was stratified by clinical site, number of diseased vessels, and ejection fraction within three different clinical subgroups. Patients with angina and ejection fractions of at least 0.50 were randomized within group A (n =514), those with angina and EF less than 0.50 were randomized within group B (n=106) and those free of angina after well-documented MI were randomized within group C (n=160).A total of 954 distal anastomoses were constructed in 357 patients in the surgical group, an average of 2.7 per patient. A total of 334 distal anastomoses were evaluated in the 129 patients; 90% of the grafts were open, 97% of patients had at least one open graft, and in 81% of patients all grafts were patent. Medical therapy consisted mostly of nitrates, and beta-blockers. Statin drugs were not available during the trial. Endpoint The primary endpoint was all-cause mortality. It was assessed with the intention-to-treat method. Results There were no significant differences in mortality.At 5 years, the average annual mortality rate in patients assigned to surgical treatment was 1.1%. The annual mortality rate in those receiving medical therapy was 1.6%. Expressed differently, the rate of death at 5 years was 9.2% in the medical group versus 7.4% in the surgical group. Annual mortality rates in patients with single-, double-, and triple-vessel disease who were in the surgical group were 0.7%, 1.0%, and 1.5%; the corresponding rates in patients in the medical group were 1.4%, 1.2%, and 2.1%.There were also no significant differences in survival when patients were grouped according to degree of coronary artery disease (number of vessels) or EF or by a combination of diseased vessels and EF.Crossovers did occur. Approximately 23% of the 390 patients assigned to the medical group had surgery during the follow-up period (4.7% per year). Of the patients assigned to surgery, 31 of 390 patients (8%) did not have surgery.Conclusions The CASS authors write in the abstract of the manuscript that they observed excellent long-term survival in both groups and that for patients similar to those in the trial, surgery could be deferred until symptoms worsen.The CASS trial had caveats. First was that the 780 patients enrolled in the trial were highly selected from a total of more than 16,000 patients in the registry. The CASS registry revealed widely disparate annual mortality in patients managed medically, ranging from 1.3% for those with single-vessel disease and normal EF to 12.5% in those with three-vessel disease and impaired EF. Another caveat was the lower-than-expected annual mortality in the medical arm of only 1.6%. This was lower than previous surgery trials (3.3% noted in the European Collaborative Study and 4.3% reported in the Veterans Administration Study). CASS authors estimated a 2-4% annual mortality. This reduces the power to find differences in the two groups.It is interesting however, that for the 1319 patients in whom their physician declined randomization, the outcome in those treated medically was similar to that reported in the randomly assigned patients who received medical therapy.In conclusion, as early as the 1980s, the CASS study showed that stable coronary artery disease was quite stable, and that revascularization in selected patients did not improve survival over medical therapy. Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support our work, consider becoming a free or paid subscriber. Get full access to Cardiology Trial's Substack at cardiologytrials.substack.com/subscribe

Lancet 1982;320:1173-1180Background: The first coronary artery bypass graft surgery (CABG) was performed in 1964 and by the 1970's it was commonly used for relief of angina. However, whether it improved survival was unknown. The European Coronary Surgery Study (ECSS) sought to test the hypothesis that CABG compared to medical therapy improved survival at 5 years.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support our work, consider becoming a free or paid subscriber.Note to readers: Several preliminary reports of ECSS results were published at earlier time points (2 and 3-5 years). We are reporting the 5-year results since this was the prespecified hypothesis the investigators sought to test.Patients: Men under 65 years of age with angina pectoris of more than 3 months duration, a left ventricular ejection fraction >50%, and angiographic obstruction of >/=50% in at least 2 major coronary vessels with at least 1 vessel suitable for grafting. Patients with severe angina that could not be controlled with medical therapy were excluded.Baseline characteristics: No information is provided in the main paper on the number or characteristics of individuals screened to enrolled. There were 768 patients enrolled in the study. They were recruited from September, 1973 to March, 1976. The average age of patients was 50 years and the left ventricular ejection fraction was 65%. Approximately, 46% had a previous heart attack, 43% smoked, 35% had a high cholesterol, 15% had hypertension and 6% had diabetes. In terms of coronary anatomy, 53% had 3-vessel disease, 40% had 2-vessel disease, and 7% had left main disease.Procedures: Patients were randomly assigned to receive medical or surgical treatment. Medical measures varied based on location. The authors reported that strict standardization was not felt to be practical or necessary. Surgical treatment was either with saphenous-vein graft or internal mammary artery and was performed as soon as possible following randomization. The average time from randomization to surgery was approximately 4 months.Follow-up evaluations were performed 6 months after randomization and annually thereafter. Graft angiography was planned at 6 and 12 months after operation.Endpoints: The primary endpoint was all-cause death. The prespecified minimum follow-up time, set at the start of the trial, for all patients was 5 years. At the time of this report, some patients had been followed up to 8 years. A strict hypothesis was not tested (i.e., CABG would reduce death by X% compared to medical therapy). The primary analysis was a traditional intention to treat analysis and medical patients who crossed over to surgery and surgical patients who died prior to receiving surgery or refused surgery after randomization were retained within their original groups.Results: There were 767 patients included in the final analysis; 373 patients in the medical group and 394 in the surgical group (1 patient was lost from the surgical group immediately following randomization and was not counted in the group). At 5 years, 90 patients (24%) of the medical group had crossed over to surgery and 26 (7%) of the surgical patients were not operated on. An average of 1.9 grafts per patient were performed in the 2-vessel disease subgroup and 2.4 grafts per patient in the 3-vessel disease subgroup. The graft patency rate was 90% within 9 months and 77% between 9 and 18 months.Compared to medical therapy, surgery significantly reduced death at 5 years by 53% (7.6% vs 16.4%; p=0.00025). Operative (in-hospital) mortality was 3.6% for a total of 494 operations and 7.7% for 26 reoperations. Seven of 27 prespecified variables recorded at the time of randomization were found to be associated with significant treatment effect heterogeneity. They included: (i) extent of disease; (ii) location of lesion(s) in the proximal third of the left anterior descending artery (proximal LAD); (iii) resting ECG suggestive of previous possible or probable myocardial infarction and/or with other specified abnormalities (iv) ischemic ST-segment response predominantly in lead V5 during maximum level of a multistage symptom/sign-limited bicycle exercise test; (v) history of peripheral arterial disease; (vi) age; and (vii) mode of treatment.Subgroup analysis on the basis of coronary anatomy supported a significant advantage of surgery for patients with left main disease (14.3% vs 32.1%; p=0.11) and 3-vessel disease (6% vs 17.6%; p=0.003) but not in 2-vessel disease (8.8% vs 11.8%; p>0.20). The left main subgroup could have had 2- or 3-vessel disease and the p-value was insignificant due to the small sample size.Surgery significantly reduced death in patients with proximal LAD disease (7.3% vs 18%; p=0.0004) but not in those without it (6.7% vs 7.9%; p>0.20). In the subset of patients with 2-vessel disease and without proximal LAD disease, surgery caused a numerical increase in death at 5 years, attributed to operative mortality.Surgery significantly reduced death in patients with >/= 1.5mm exertional ST depression on bicycle testing (8.3% vs 21%; p=0.003) but not in those without it (5.1% vs 9.7%; p>0.20).Angina and exercise performance were significantly improved in the surgery group compared to medicine. Conclusions: Compared to medical therapy, bypass surgery using internal mammary arteries and saphenous vein grafts significantly reduced mortality at 5 years in men under 65 years of age with normal left ventricular function. Approximately 11 men would need to be treated with CABG to prevent 1 death. This represents a large benefit for bypass surgery in well-selected patients at the time the study was undertaken. Contemporary caveats to this interpretation include improvements in medical therapy since the publication of ECSS mainly involving aspirin and cholesterol lowering drugs for patients with CAD as well as an improvement in the general management of conditions like hypertension and diabetes. Also, smoking rates have significantly declined at the population level.Despite the impressive benefit of bypass surgery seen in this study, important treatment effect heterogeneity was identified for certain lower risk patient groups including those with 2-vessel disease, absence of proximal LAD disease, and minimal ST depression on symptom limited bicycle testing. Theoretically, such patients would be expected to benefit from bypass surgery even less today given the improvements in medical therapy mentioned above.Finally, it is worth pointing out the difference in treatment effects seen in this study compared to the Veterans Administration Cooperative Study that we reviewed earlier this week, which was a negative trial. In the Veterans Administration Cooperative Study, coronary bypass was performed primarily with saphenous vein grafting whereas ECSS used internal mammary arteries and saphenous vein grafts. Internal mammary arteries are superior conduits compared to vein grafts. They have improved long-term patency rates, which is attributed to their striking resistance to the development of atherosclerosis. Furthermore, they are used almost exclusively on the LAD, which is the most important vessel.In conclusion, ECSS demonstrated that CABG surgery dramatically reduced death at 5 years compared to medical treatment; however, we should be aware of the caveats mentioned above and appreciate that the trial was limited to highly selected male patients under the age of 65.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support our work, consider becoming a free or paid subscriber. Get full access to Cardiology Trial's Substack at cardiologytrials.substack.com/subscribe

In this interview, Kati chats with Jeannie Cisney, MSN RN. She is a 20+ year veteran of the CVICU (cardiovascular intensive care unit). We discuss: The types of patients you'll see in a CVICU Her favorite and least favorite types of patients A walkthrough of the patient pathway of a typical CABG patient New grad vs. experienced nurse orientation experience into CVICU Unexpected challenges of CVICU RNs The advice she'd give her younger self Jeannie is my co-author of Cardiac Confidence, a Crash Course for New Cardiac Nurses. To learn more and enroll, click here: https://courses.freshrn.com/p/cardiac-confidence  For a 14-page ECG cheatsheet: https://bit.ly/3Ws75NT For a free mini-course on how to handle afib with RVR: https://courses.freshrn.com/p/afib-with-rvr  For my cardiac assessment checklist: https://bit.ly/4aV6RTO For ALL of our cardiac content: https://www.freshrn.com/cardiac-nursing/  Learn more about the FreshRN All-Access Pass here - https://courses.freshrn.com/p/membership To see our latest course catalog (med-surg, ICU, precepting, charge nurse, ortho, cardiac, neuro courses, and more), click here: https://courses.freshrn.com/ Get weekly tips, encouragement, stories from the bedside, and more - just for nursing students and new nurses at: https://www.freshrn.com/email-sign-up/  Connect With Me Online! Facebook: https://www.facebook.com/FreshRN Twitter: https://twitter.com/Kati_Kleber Pinterest: https://www.pinterest.com/Fresh_RN/ Instagram: https://www.instagram.com/kati_kleber/ TikTok: https://www.tiktok.com/@freshrn Music credit: Keep My Cool by Benj Heard  

CardioNerds co-founder Dan Ambinder joins Dr. Lefan He, Dr. Sina Salehi Omran, and Dr. Neil Gupta from the University of Rochester Cardiovascular Disease Fellowship Program for a day sailing on Lake Ontario. Expert commentary is provided by Dr. Jeffrey Bruckel, and CV Fellowship Program Director Dr. Burr Hall shares insights on the University of Rochester fellowship. The episode audio was edited by CardioNerds intern Dr. Atefeh Ghorbanzadeh. They discuss the following case involving a patient with papillary muscle rupture. This is a 63-year-old man with hypertension, hyperlipidemia, and active tobacco smoking who presented with acute dyspnea. He was tachycardic but otherwise initially hemodynamically stable. The physical exam demonstrated warm extremities with no murmurs or peripheral edema. Chest X-ray revealed diffuse pulmonary edema, and the ECG showed sinus tachycardia with T-wave inversions in the inferior leads. A bedside echocardiogram revealed a flail anterior mitral valve leaflet. The patient was taken for cardiac catheterization that revealed nonobstructive mid-RCA atheroma with a distal RCA occlusion, which was felt to reflect embolic occlusion from recanalized plaque. PCI was not performed. Right heart catheterization then demonstrated a low cardiac index as well as elevated PCWP and PA pressures. An intra-aortic balloon pump was placed at that time. A TEE was performed soon after which showed the posteromedial papillary muscle was ruptured with flail segments of the anterior mitral leaflet as well as severe posteriorly directed mitral regurgitation. The patient ultimately underwent a successful tissue mitral valve replacement and CABG. US Cardiology Review is now the official journal of CardioNerds! Submit your manuscript here. CardioNerds Case Reports PageCardioNerds Episode PageCardioNerds AcademyCardionerds Healy Honor Roll CardioNerds Journal ClubSubscribe to The Heartbeat Newsletter!Check out CardioNerds SWAG!Become a CardioNerds Patron! case Media Pearls - A Case of Papillary Muscle Rupture Most cases of papillary muscle rupture demonstrate only small areas of ischemia with preserved ventricular function, thus causing high shear force on the ischemic papillary muscle. The posteromedial papillary muscle has a single blood supply from the posterior descending artery, while the anterolateral papillary muscle has a dual blood supply from the LAD and the circumflex. Therefore, the posteromedial papillary muscle is more vulnerable to ischemia and, hence, rupture. A murmur may be absent in cases of papillary muscle rupture due to the rapid equalization of left atrial and left ventricular pressures caused by the acuteness of the severe MR. Papillary muscle rupture should always be on the differential for acute dyspnea when ACS is suspected. While mostly associated with STEMIs, mechanical complications of acute myocardial infarctions can also occur after NSTEMIs. Always auscultate patients carefully after a myocardial infarction! When evaluating patients with chest pain presenting with acute or rapidly progressive heart failure and a hypercontractile LVEF should raise suspicion for mechanical complications of MI. Once a papillary muscle rupture is diagnosed, cardiac surgery should be immediately contacted. Temporizing measures prior to surgery include positive pressure ventilation, IV nitroglycerin/nitroprusside, and temporary mechanical circulatory support. Notes - A Case of Papillary Muscle Rupture What is the clinical presentation of acute mitral regurgitation from papillary muscle rupture? Patients typically present 3-5 days after a transmural infarct. Roughly half of these patients present with pulmonary edema that may quickly progress to cardiogenic shock. Most cases are associated with STEMIs, but papillary muscle rupture is also possible with an NSTEMI.

N Engl J Med 2015;372:2387-2397Background: Statins, inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A reductase, effectively lower low-density lipoprotein (LDL) and improve cardiovascular outcomes across different populations. High-intensity statins exhibit greater efficacy in lowering LDL and decreasing non-fatal cardiac events compared to moderate-intensity statins. Nonetheless, due to the residual risk of cardiac events, and concerns about the safety and tolerability of high intensity statins, there is a growing demand for newer therapeutic options.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.Ezetimibe acts on the Niemann–Pick C1–like 1 (NPC1L1) protein, inhibiting cholesterol absorption from the intestine. When combined with statins, ezetimibe further decreases LDL levels by an average of 23 to 24%.The IMPROVE-IT trial sought to test the hypothesis that adding ezetimibe to simvastatin is superior to simvastatin alone in reducing cardiovascular events in patients with recent acute coronary syndrome.Patients: Patients were enrolled if they had acute coronary syndrome (STEMI, NSTEMI or high-risk unstable angina) in the preceding 10 days, and were at least 50 years old. LDL levels within 24 hours of the acute coronary syndrome (ACS) had to be at least 50 mg/dL but less than or equal to 125 mg/dL in lipid-therapy naïve patients or less than or equal to 100 mg/dL in patients receiving lipid lowering therapy. Patients were excluded if they had hemodynamic or electrical instability following the ACS event, planned CABG, active liver disease, creatinine clearance< 30 ml/min, or they had chronic lipid lowering therapy of simvastatin> 40mg, atorvastatin 40mg or more, any dose of rosuvastatin, or any ezetimibe/simvastatin combination.Baseline characteristics: The average age of patients was 64 years with 76% being men. The average weight was 83 kg. About 27% had diabetes, 61% had hypertension, 21% had prior myocardial infarction, 4% had congestive heart failure and 33% were current smokers. The median creatinine clearance was 85 ml/ min. The index event was STEMI in 29% of the patients, NSTEMI in 47% and unstable angina in the rest. Coronary angiogram was performed in 88% of the patients and percutaneous coronary intervention was performed in 70%. The mean LDL was 94 mg/dL and was similar in both groups.Procedures: Patients were randomized 1:1 in a double blinded fashion to receive simvastatin 40mg daily plus ezetimibe 10mg daily or simvastatin 40mg daily plus placebo. Patients had follow-up visits at 30 days, 4 months, and every 4 months thereafter.In both study groups, if LDL level was higher than 79 mg/dL on two consecutive measurements, the simvastatin dose was increased to 80 mg per day. This practice continued until June 2011, approximately one year after the study's randomization concluded, when the Food and Drug Administration advised limiting new prescriptions of simvastatin 80 mg daily. If LDL levels were higher than 100 mg/dL on the new regimen, the study drug could be discontinued, and more potent therapy could be initiated. Patients were followed for at least 2.5 years and for up to 7 years.Endpoints: The primary efficacy end point was a composite endpoint of death from cardiovascular disease, a major coronary event (defined as nonfatal myocardial infarction, unstable angina requiring hospital admission, or coronary revascularization occurring at least 30 days after randomization), or nonfatal stroke. The trial also reported death from any cause as part of one of the secondary composite endpoints. Safety variables included liver enzymes and creatine kinase levels, myopathy or rhabdomyolysis, gallbladder-related adverse events or cancer.Statistical analysis was performed based on the intention-to-treat principle. To achieve 90% power for detecting 9.375% lower relative risk for the primary end point with simvastatin–ezetimibe combination compared to simvastatin alone, an estimated sample size of 18,000 patients and 5,250 primary events was required.Results: The trial randomized 18,144 patients in 39 countries; 9067 randomized to the simvastatin–ezetimibe combination and 9077 to the simvastatin monotherapy group.The simvastatin–ezetimibe combination led to greater reduction in LDL. At 1 year, the mean LDL was 53 mg/dL in the simvastatin–ezetimibe combination group and 70 mg/dL in the simvastatin monotherapy group. The simvastatin dose was increased to 80mg per day in 6% of the patients in the simvastatin–ezetimibe group and 27% in the simvastatin monotherapy group.The use of simvastatin–ezetimibe led to greater reduction in the primary endpoint compared simvastatin monotherapy (32.7% vs 34.7%, HR: 0.94; 95% CI: 0.89 - 0.99; p= 0.016). This reduction in the composite primary endpoint was primarily driven by reduction in non-fatal myocardial infarction (12.8% vs 14.4%) as well as ischemic stroke (3.4% vs 4.1%). There was no significant difference in death from any cause (15.4% vs 15.3%) or death from cardiovascular causes (6.9% vs 6.8%).The benefits of simvastatin–ezetimibe were more pronounced in patients who were 75 years or older (39.0% vs 47.6%, HR 0.80, 95% CI: 0.70 - 0.90; p for interaction= 0.005) and in patients with diabetes (40.0% vs 45.5%, HR: 0.86, 95% CI: 0.78 - 0.94; p for interaction= 0.023).No significant differences in safety endpoints were observed between both groups. Elevation of liver enzymes 3 times or more the upper limited of normal occurred in 2.5% of the patients in the simvastatin–ezetimibe combination group and 2.3% in the simvastatin monotherapy group.Conclusion: In patients with recent acute coronary syndrome, the combination of simvastatin–ezetimibe as compared to simvastatin monotherapy improved the primary composite outcome of death from cardiovascular disease, major coronary events, or nonfatal stroke. This reduction was modest, about 6% relative reduction, and was primarily driven by reduction in non-fatal myocardial infarctions and ischemic strokes. The trial results supports the hypothesis that lower LDL levels improves outcomes regardless of how it's achieved. The trial has good interval validity but the external validity is limited in the current era because simvastatin is infrequently used nowadays with atorvastatin and rosuvastatin being the preferred agents. Patients taking atorvastatin 40mg or more and patients taken any dose of rosuvastatin at baseline were excluded from the trial. Furthermore, it's unclear why the trial did not permit the inclusion of patients whose LDL exceeded certain limits as only patients with mild elevation in LDL at baseline were permitted to be enrolled.This trial does not answer the question most physicians may encounter in their practice: What's the benefit of adding ezetimibe to high-intensity statins or prescribing it to patients with moderate or high elevation in LDL levels?Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber. Get full access to Cardiology Trial's Substack at cardiologytrials.substack.com/subscribe