Background: Several trials reported differential outcomes after percutaneous coronary intervention with drug‐eluting stents (DES) and coronary‐artery bypass grafting (CABG) for multivessel coronary disease according to the presence of diabetes mellitus (DM). However, it is not well recognized how DM status affects very‐long‐term (10‐year) outcomes after DES and CABG for left main coronary artery disease. Methods and Results: In the PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty using Sirolimus‐Eluting Stent in Patients with Left Main Coronary Artery Disease) trial, patients with LMCA were randomly assigned to undergo PCI with sirolimus‐eluting stents (n=300) or CABG (n=300). The primary outcome was the incidence of major adverse cardiac or cerebrovascular events (MACCE; a composite of death from any cause, myocardial infarction, stroke, or ischemia‐driven target‐vessel revascularization). Outcomes were examined in patients with (n=192) and without (n=408) medically treated diabetes. The follow‐up was extended to at least 10 years for all patients (median, 11.3 years). The 10‐year rates of MACCE were not significantly different between DES and CABG in patients with DM (36.3% versus 26.7%, respectively; hazard ratio [HR], 1.35; 95% CI, 0.83–2.19; P =0.23) and without DM (25.3% versus 22.9%, respectively; HR, 1.15; 95% CI, 0.79–1.67; P =0.48) ( P ‐for‐interaction=0.48). There were no significant between‐group differences in composite of death, MI, or stroke, and all‐cause mortality, regardless of DM status. TVR rates were consistently higher after DES than CABG. Conclusions: In this 10‐year extended follow‐up of PRECOMBAT, we found no significant difference between DES and CABG with respect to the incidences of MACCE, serious composite outcome, and all‐cause mortality in patients with and without DM with LMCA disease. However, owing to the limited number of patients and no adjustment for multiple testing, overall findings should be considered hypothesis‐generating, highlighting the need for further research. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03871127 and NCT00422968.

Background: The long‐term prognostic effect of the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score (SS) after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) for left main coronary artery disease is controversial. Methods and Results: In the PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus‐Eluting Stent in Patients With Left Main Coronary Artery Disease) trial, 600 patients with left main coronary artery disease were randomized to undergo PCI with drug‐eluting stents (n=300) or CABG (n=300). We compared 10‐year outcomes after PCI and CABG according to SS categories and evaluated the predictive value of SS in each revascularization arm. The primary outcome was a major adverse cardiac or cerebrovascular event (composite of death, myocardial infarction, stroke, or ischemia‐driven target‐vessel revascularization) at 10 years. Among 566 patients with valid SS measurement at baseline, 240 (42.4%) had low SS, 200 (35.3%) had intermediate SS, and 126 (22.3%) had high SS. The 10‐year rates of major adverse cardiac or cerebrovascular events were not significantly different between PCI and CABG in low (21.6% versus 22.2%, P =0.97), intermediate (31.8% versus 22.2%; P =0.13), and high SS (46.2% versus 35.7%; P =0.31) ( P ‐for‐interaction=0.46). There were no significant interactions between SS categories and revascularization modalities for death ( P =0.92); composite of death, myocardial infarction, or stroke ( P =0.87); and target‐vessel revascularization ( P =0.06). Higher SS categories were associated with higher risks for major adverse cardiac or cerebrovascular events in the PCI arm but not in the CABG arm. Conclusions: Ten‐year clinical outcomes between PCI and CABG were not significantly different according to the SS. The SS was predictive of major adverse cardiac or cerebrovascular events after PCI but not after CABG. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03871127.

Korean Circulation Journal 대한심장학회지 순환기 Yoon YH, et al. Korean Circ J. 2021 Nov;52:e5. https://doi.org/10.4070/kcj.2021.0240

Background: Various ECG criteria for left ventricular hypertrophy (LVH) have been proposed, but their association with clinical outcomes in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement is unknown. We investigated the prevalence of ECG LVH according to different criteria and its prognostic impact on clinical outcomes after transcatheter aortic valve replacement. Methods and Results: In this prospective observational cohort, we evaluated 700 patients who underwent transcatheter aortic valve replacement between March 2010 and December 2019. Baseline preprocedural LVH was defined by 3 ECG criteria—Sokolow‐Lyon, Romhilt‐Estes, and Cornell voltage criteria. The primary outcome was major adverse cardiac or cerebrovascular event (MACCE; composite of death, myocardial infarction, stroke, or rehospitalization from cardiovascular cause); the key secondary outcome was all‐cause and cardiovascular mortality. Among 596 eligible patients, the prevalence of LVH was determined as 56.3% by Sokolow‐Lyon, 31.1% by Romhilt‐Estes, and 48.1% by Cornell criteria. Regardless of the criteria, patients with ECG LVH had more severe aortic stenosis hemodynamics and higher left ventricular mass index. After multivariate adjustment, the presence of LVH by the Cornell criteria was significantly associated with lower risks of MACCE (adjusted hazard ratio [HR], 0.68; 95% CI, 0.51–0.91; P =0.009), all‐cause mortality (adjusted HR, 0.55; 95% CI, 0.34–0.90 [ P =0.017]), and cardiovascular mortality (adjusted HR, 0.40; 95% CI, 0.20–0.79 [ P =0.008]). However, this association was absent with the Sokolow‐Lyon and Romhilt‐Estes criteria. Conclusions: ECG LVH by Cornell criteria only was significantly associated with lower risks of MACCE and all‐cause or cardiovascular mortality. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03298178.

Background: The long‐term impact of newly discovered, asymptomatic abnormal ankle–brachial index (ABI) in patients with significant coronary artery disease is limited. Methods and Results: Between January 2006 and December 2009, ABI was evaluated in 2424 consecutive patients with no history of claudication or peripheral artery disease who had significant coronary artery disease. We previously reported a 3‐year result; therefore, the follow‐up period was extended. The primary end point was a composite of all‐cause death, myocardial infarction (MI), and stroke over 7 years. Of the 2424 patients with significant coronary artery disease, 385 had an abnormal ABI (ABI ≤0.9 or ≥1.4). During the follow‐up period, the rate of the primary outcome was significantly higher in the abnormal ABI group than in the normal ABI group ( P <0.001). The abnormal ABI group had a significantly higher risk of composite of all‐cause death/MI/stroke than the normal ABI group, after adjustment with multivariable Cox proportional hazards regression analysis (hazard ratio [HR], 2.07; 95% CI, 1.67–2.57; P <0.001) and propensity score–matched analysis (HR, 1.97; 95% CI, 1.49–2.60; P <0.001). In addition, an abnormal ABI was associated with a higher risk of all‐cause death, MI, and stroke, but not repeat revascularization. Conclusions: Among patients with significant coronary artery disease, asymptomatic abnormal ABI was associated with sustained and increased incidence of composite of all‐cause death/MI/stroke, all‐cause death, MI, and stroke during extended follow‐up over 7 years.

Background: There are still limited data about the differential effect of sex on long‐term outcomes after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for left main coronary artery disease. This extended follow‐up study of the MAIN‐COMPARE (Ten‐Year Outcomes of Stents Versus Coronary‐Artery Bypass Grafting for Left Main Coronary Artery Disease) registry evaluated clinical outcomes beyond 10 years. Methods and Results: Of 2240 patients with unprotected left main coronary artery disease (PCI=1102 and CABG=1138), all‐cause mortality, the composite of death, Q‐wave myocardial infarction, or stroke, and target vessel revascularization were separately evaluated in both sexes. Of 2240 patients, 631 (28.2%) were women and 1609 (71.8%) were men. Women had lower 10‐year incidences of death and serious composite outcomes than men. The adjusted 10‐year risks of adverse outcomes were similar in men. However, the adjusted 10‐year risks were different according to a prespecified period in women. In the short‐term (0–1 year) period, PCI had a significantly lower risk for serious composite outcomes (adjusted hazard ratio [HR], 0.41; 95% CI, 0.19–0.91; P =0.03) compared with CABG. The adjusted risks for death and serious composite outcomes were significantly higher after PCI than after CABG, during the midterm (1–5 years) period (death; adjusted HR, 3.99; 95% CI, 2.01–7.92; P <0.001 and composite outcome; adjusted HR, 2.93; 95% CI, 1.59–5.39; P =0.001). Beyond 5 years, adjusted risks were similar after PCI and CABG in women. Conclusions: In this 10‐year extended follow‐up study of patients undergoing left main coronary artery revascularization, we observed a time‐dependent impact of sex on the long‐term outcomes after PCI and CABG, especially in women, with significant interactions. However, these results warrant confirmation on larger series of studies. Registration: URl: https://www.clinicaltrials.gov ; Unique identifier: NCT02791412.