Prognostic Value of Sex After Revascularization for Left Main Coronary Disease: Extended PRECOMBAT Study

BACKGROUND: Female subjects have poorer outcomes in left main coronary artery (LMCA) disease compared with male subjects. However, limited information is available on the long-term prognostic impact of sex and sex–treatment interactions in patients with LMCA disease undergoing coronary revascularization. OBJECTIVES: The goal of this study was to investigate the long-term effects of sex and related differential outcomes after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in LMCA disease. METHODS: The extended PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease) trial evaluated the >10-year clinical outcomes in patients with LMCA disease randomized to undergo PCI with drug-eluting stents (n = 300) or CABG (n = 300). The primary outcome was major adverse cardiac or cerebrovascular events (MACCE) (composite of death, myocardial infarction, stroke, or ischemia-driven target vessel revascularization) at 10 years. RESULTS: Of the 600 patients, 459 (76.5%) were male. The 10-year rates of MACCE were similar between male and female subjects in the overall cohort (27.3% vs 27.0%; adjusted hazard ratio [aHR]: 1.06; 95% confidence interval [CI]: 0.70-1.59), the PCI arm (30.6% vs 27.1%; aHR: 1.19; 95% CI: 0.69-2.05), and the CABG arm (24.0% vs 26.9%; aHR: 0.93; 95% CI: 0.53-1.62). The 10-year risks for MACCE did not significantly differ between PCI and CABG in both male (aHR: 1.37; 95% CI: 0.95-1.97) and female (aHR: 1.07; 95% CI: 0.56-2.07) subjects. There was no significant sex–treatment interaction regarding the adjusted risk of MACCE at 10 years (P for interaction = 0.52). CONCLUSIONS: In this 10-year follow-up of the PRECOMBAT trial, there was no sex-related impact on the long-term risk of MACCE after PCI and CABG for LMCA disease. (Ten-Year Outcomes of PRECOMBAT Trial; NCT03871127)