Background: Long-term comparative outcomes after percutaneous coronary intervention (PCI) with everolimus-eluting stent and coronary-artery bypass grafting (CABG) are limited in patients with multivessel coronary artery disease.
Methods: This prospective, multicenter, randomized, controlled trial was conducted in 27 international heart centers and was designed to randomly assign 1776 patients with angiographic multivessel coronary artery disease to receive PCI with everolimus-eluting stent or CABG. After inclusion of 880 patients (438 in the PCI group and 442 in the CABG group) between July 2008 and September 2013, the study was terminated early due to slow enrollment. The primary end point was the composite of death from any cause, myocardial infarction, or target-vessel revascularization.
Results: During a median follow-up of 11.8 years (interquartile range, 10.6 to 12.5 years, maximum 13.7 years), the primary end point occurred in 151 patients (34.5%) in the PCI group and 134 patients (30.3%) in the CABG group (hazard ratio [HR] 1.18; 95% confidence interval [CI], 0.88 to 1.56; P=0.26). No significant differences were seen in the occurrence of a safety composite of death, myocardial infarction, or stroke between groups (28.8% and 27.1%, HR 1.07; 95% CI 0.75 to 1.53; P=0.70) as well as the occurrence of death from any cause (20.5% and 19.9%, HR 1.04; 95% CI 0.65 to 1.67; P=0.86). However, spontaneous myocardial infarction (7.1% and 3.8%, HR 1.86; 95% CI 1.06 to 3.27; P=0.031) and any repeat revascularization (22.6% and 12.7%, HR 1.92; 95% CI 1.58 to 2.32; P<0.001) were more frequent after PCI than after CABG.
Conclusions: In patients with multivessel coronary artery disease, there were no significant differences between PCI and CABG in the incidence of major adverse cardiac events, safety composite end point, and all-cause mortality during extended-follow-up.