From 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).
N Engl J Med. 2016 Dec 8;375(23):2223-2235. doi: 10.1056/NEJMoa1610227. Epub 2016 Oct 31.
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.
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.
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).
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 .).
通常，患有左主干冠状动脉阻塞性疾病的患者会接受冠状动脉旁路移植术（CABG）治疗。随机试验表明，在某些患有左主干冠状动脉疾病的患者中，药物洗脱支架可能是 CABG 的可接受替代方法。
我们随机分配了 1905 名患有低或中解剖复杂性左主干冠状动脉疾病的合格患者，分别接受基于氟聚合物的钴铬依维莫司洗脱支架的经皮冠状动脉介入治疗（PCI 组，948 例患者）或 CABG（CABG 组，957 例患者）。解剖复杂性在部位进行评估，并通过 SYNTAX 评分（SYNTAX 评分反映了冠状动脉血管的综合血管造影评估，0 分为最低评分，更高的分数[无上限]表示更复杂的冠状动脉解剖结构）定义为 32 分或更低。主要终点是 3 年时任何原因导致的死亡、卒中和心肌梗死的复合发生率，该试验具有非劣效性测试主要终点的能力（非劣效性边界为 4.2 个百分点）。主要次要终点包括 30 天时任何原因导致的死亡、卒中和心肌梗死的复合发生率，以及 3 年时死亡、卒中和心肌梗死或缺血驱动的血运重建的复合发生率。事件发生率基于首次事件时间分析中的 Kaplan-Meier 估计。
3 年后，PCI 组中有 15.4%的患者发生了主要终点事件，CABG 组中有 14.7%的患者发生了主要终点事件（差异为 0.7 个百分点；上 97.5%置信区间为 4.0 个百分点；P=0.02 表示非劣效性；危险比为 1.00；95%置信区间为 0.79 至 1.26；P=0.98 表示优势）。30 天时死亡、卒中和心肌梗死的次要终点事件在 PCI 组中发生了 4.9%，在 CABG 组中发生了 7.9%（P<0.001 表示非劣效性，P=0.008 表示优势）。3 年后死亡、卒中和心肌梗死或缺血驱动的血运重建的次要终点事件在 PCI 组中发生了 23.1%，在 CABG 组中发生了 19.1%（P=0.01 表示非劣效性，P=0.10 表示优势）。
在左主干冠状动脉疾病和低或中解剖复杂性的患者中，基于支架的经皮冠状动脉介入治疗与冠状动脉旁路移植术相比，在 3 年时的死亡、卒中和心肌梗死复合终点发生率方面不劣效。（由 Abbott Vascular 资助；EXCEL 临床试验.gov 编号，NCT01205776）。
