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

Abstract

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).

Keywords: CABG, coronary artery bypass grafting; CAD, coronary artery disease; CI, confidence interval; DES, drug-eluting stents; HR, hazard ratio; LMCA, left main coronary artery; MACCE, major adverse cardiac or cerebrovascular events; MI, myocardial infarction; PCI, percutaneous coronary intervention; RCT, randomized controlled trial; TVR, target vessel revascularization; coronary artery bypass surgery; left main coronary artery disease; mortality; percutaneous coronary intervention; sex.

Conflict of interest statement

This research was partly supported by the Cardiovascular Research Foundation. The sponsors had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or the decision to submit the manuscript for publication. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

© 2022 The Authors.

Figures

Graphical abstract

Figure 1

10-Year Event Curves for the Primary Endpoint Between Male and Female Subjects Event curves are shown in the overall cohort (A), the percutaneous coronary intervention (PCI) arm (B), and the coronary artery bypass grafting (CABG) arm (C). P values are derived from the log-rank test. Primary endpoint was major adverse cardiac or cerebrovascular events, which was defined as a composite of death from any cause, nonfatal myocardial infarction, nonfatal stroke, or ischemia-driven target vessel revascularization.

Central Illustration

Adjusted Hazard Ratios for the Primary Endpoint According to Sex and Treatment Adjusted hazard ratios (95% CI) were stratified according to sex group (A) and treatment group (B). Adjusted variables included age, medically treated diabetes, clinical presentation, ejection fraction, left main bifurcation involvement, SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score, and EuroSCORE (European System for Cardiac Operative Risk Evaluation). Primary end point was major adverse cardiac or cerebrovascular events, which was defined as a composite of death from any cause, nonfatal myocardial infarction, nonfatal stroke, or ischemia-driven target vessel revascularization. CABG = coronary artery bypass grafting; PCI = percutaneous coronary intervention.

Figure 2

10-Year Event Curves of the Primary Endpoint Between PCI and CABG Event curves are shown in the male cohort (A) and female cohort (B). P values are derived from the log-rank test. Primary endpoint was major adverse cardiac or cerebrovascular events, which was defined as a composite of death from any cause, nonfatal myocardial infarction, nonfatal stroke, or ischemia-driven target vessel revascularization. Abbreviations as in Figure 1.