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N Engl J Med. 2016 Dec 8;375(23):2223-2235. Epub 2016 Oct 31.

Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease.

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  • 1From New York Presbyterian Hospital and Columbia University Medical Center (G.W.S.), the Cardiovascular Research Foundation (G.W.S., P.G., O.D., I.K., R.M.), and Mount Sinai Medical Center (J. Puskas, R.M.), New York; the Cleveland Clinic Foundation, Cleveland (J.F.S.); the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), and London School of Hygiene and Tropical Medicine (S.J.P.), London, Oxford University Hospitals, Oxford (D.P.T., A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Abbott Vascular, Santa Clara, CA (C.A.S.); Hôpital du Sacré-Coeur de Montréal (P.G., E.S., P.P.) and Centre Hospitalier de l'Université de Montréal, Hôpital Hôtel-Dieu de Montréal (S.M., N.N.), Montreal; Piedmont Hospital, Atlanta (D.E.K., N.L., W.M.B.); Ramsay Générale de Santé, Hopital Privé Jacques Cartier, Massy, France (M.-C.M.); Semmelweis University, Budapest (B.M., F.H.) and University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Erasmus Medical Center, Rotterdam (A.P.K.) - both in the Netherlands; Hospital Clinic, Barcelona (M.S., J. Pomar); and Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.B., A. Bochenek).

Abstract

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 .).

PMID:
27797291
DOI:
10.1056/NEJMoa1610227
[PubMed - indexed for MEDLINE]
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