Background Patients with obstructive left main coronary artery disease are usually
treated with coronary-artery bypass grafting (CABG). Randomized trials have suggested
that drug-eluting stents may be an acceptable alternative to CABG in selected patients
with left main coronary disease. Methods We randomly assigned 1905 eligible patients
with left main coronary artery disease of low or intermediate anatomical complexity
to undergo either percutaneous coronary intervention (PCI) with fluoropolymer-based
cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG
group, 957 patients). Anatomic complexity was assessed at the sites and defined by
a Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery
(SYNTAX) score of 32 or lower (the SYNTAX score reflects a comprehensive angiographic
assessment of the coronary vasculature, with 0 as the lowest score and higher scores
[no upper limit] indicating more complex coronary anatomy). The primary end point
was the rate of a composite of death from any cause, stroke, or myocardial infarction
at 3 years, and the trial was powered for noninferiority testing of the primary end
point (noninferiority margin, 4.2 percentage points). Major secondary end points included
the rate of a composite of death from any cause, stroke, or myocardial infarction
at 30 days and the rate of a composite of death, stroke, myocardial infarction, or
ischemia-driven revascularization at 3 years. Event rates were based on Kaplan-Meier
estimates in time-to-first-event analyses. Results At 3 years, a primary end-point
event had occurred in 15.4% of the patients in the PCI group and in 14.7% of the patients
in the CABG group (difference, 0.7 percentage points; upper 97.5% confidence limit,
4.0 percentage points; P=0.02 for noninferiority; hazard ratio, 1.00; 95% confidence
interval, 0.79 to 1.26; P=0.98 for superiority). The secondary end-point event of
death, stroke, or myocardial infarction at 30 days occurred in 4.9% of the patients
in the PCI group and in 7.9% in the CABG group (P<0.001 for noninferiority, P=0.008
for superiority). The secondary end-point event of death, stroke, myocardial infarction,
or ischemia-driven revascularization at 3 years occurred in 23.1% of the patients
in the PCI group and in 19.1% in the CABG group (P=0.01 for noninferiority, P=0.10
for superiority). Conclusions In patients with left main coronary artery disease and
low or intermediate SYNTAX scores by site assessment, PCI with everolimus-eluting
stents was noninferior to CABG with respect to the rate of the composite end point
of death, stroke, or myocardial infarction at 3 years. (Funded by Abbott Vascular;
EXCEL ClinicalTrials.gov number, NCT01205776 .).
