2016-12-08
Everolimus-eluting Stents or bypass surgery for left main coronary artery disease
Publication
Publication
New England Journal of Medicine , Volume 375 - Issue 23 p. 2223- 2235
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.)
Additional Metadata | |
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doi.org/10.1056/NEJMoa1610227, hdl.handle.net/1765/94877 | |
New England Journal of Medicine | |
Organisation | Erasmus MC: University Medical Center Rotterdam |
Stone, G., Sabik, J., Serruys, P., Simonton, C., Généreux, P., Puskas, J., … Kappetein, A. P. (2016). Everolimus-eluting Stents or bypass surgery for left main coronary artery disease. New England Journal of Medicine, 375(23), 2223–2235. doi:10.1056/NEJMoa1610227 |