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

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...

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Bibliographic Details
Main Authors: Stone Gregg W.
Sabik Joseph F.
Serruys Patrick W.
Simonton Charles A.
Généreux Philippe
Puskás John
Kandzari David E.
Morice Marie-Claude
Lembo Nicholas
Merkely Béla Péter
Horkay Ferenc
Ungi Imre
Bogáts Gábor
Kollaborációs szervezet: EXCEL Trial Investigators
Fontos Géza
Székely László
Format: Article
Published: 2016
Series:NEW ENGLAND JOURNAL OF MEDICINE 375 No. 23
Subjects:
doi:10.1056/NEJMoa1610227

mtmt:3132593
Online Access:http://publicatio.bibl.u-szeged.hu/24155
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490 0 |a NEW ENGLAND JOURNAL OF MEDICINE  |v 375 No. 23 
520 3 |a 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 .). 
650 4 |a Klinikai orvostan 
700 0 1 |a Sabik Joseph F.  |e aut 
700 0 1 |a Serruys Patrick W.  |e aut 
700 0 1 |a Simonton Charles A.  |e aut 
700 0 1 |a Généreux Philippe  |e aut 
700 0 1 |a Puskás John  |e aut 
700 0 1 |a Kandzari David E.  |e aut 
700 0 1 |a Morice Marie-Claude  |e aut 
700 0 1 |a Lembo Nicholas  |e aut 
700 0 1 |a Merkely Béla Péter  |e aut 
700 0 1 |a Horkay Ferenc  |e aut 
700 0 1 |a Ungi Imre  |e aut 
700 0 1 |a Bogáts Gábor  |e aut 
700 0 2 |a Kollaborációs szervezet: EXCEL Trial Investigators  |e aut 
700 0 2 |a Fontos Géza  |e aut 
700 0 2 |a Székely László  |e aut 
856 4 0 |u http://publicatio.bibl.u-szeged.hu/24155/1/Stone.pdf  |z Dokumentum-elérés