From the Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, ON (A.L., P.J.D., R.P.W., Y.O., P.G., S.P., S.Y.), Centre Hospitalier de l'Université de Montréal, Montreal (N.N.), and the University of Calgary, Calgary, AB (R.J.N.) - all in Canada; the Center for Chronic Disease Control, Gurgaon (D.P.), SAL Hospital, Ahmedabad (A.R.J.), G. Kuppuswamy Naidu Memorial Hospital, Coimbatore (C.P.), and All India Institute of Medical Sciences, New Delhi (B.A.) - all in India; the University of Oxford, Oxford, United Kingdom (D.P.T.); Fu Wai Cardiovascular Hospital, Xicheng District, Beijing (S.H.), and Wuhan Asia Heart Hospital, Wuhan (L.T.) - both in China; Third Faculty of Medicine Charles University, University Hospital Kralovske Vinohrady, Prague, Czech Republic (Z.S.); Instituto Dante Pazzanese de Cardiologia, São Paulo (L.S.P., A.A.); Ankara University School of Medicine, Ankara, Turkey (A.R.A.); Hospital Regional de Temuco and Universidad de la Frontera, Temuco, Chile (F.L.Z., J.-C.B.); Fundación Médica de Río Negro y Neuquén, Rio Negro, Argentina (P.A.O.); and North Estonia Medical Center, Tallinn, Estonia (T.-A.S.).
N Engl J Med. 2016 Dec 15;375(24):2359-2368. doi: 10.1056/NEJMoa1601564. Epub 2016 Oct 23.
We previously reported that there was no significant difference at 30 days or at 1 year in the rate of the composite outcome of death, stroke, myocardial infarction, or renal failure between patients who underwent coronary-artery bypass grafting (CABG) performed with a beating-heart technique (off-pump) and those who underwent CABG performed with cardiopulmonary bypass (on-pump). We now report the results at 5 years (the end of the trial).
A total of 4752 patients (from 19 countries) who had coronary artery disease were randomly assigned to undergo off-pump or on-pump CABG. For this report, we analyzed a composite outcome of death, stroke, myocardial infarction, renal failure, or repeat coronary revascularization (either CABG or percutaneous coronary intervention). The mean follow-up period was 4.8 years.
There were no significant differences between the off-pump group and the on-pump group in the rate of the composite outcome (23.1% and 23.6%, respectively; hazard ratio with off-pump CABG, 0.98; 95% confidence interval [CI], 0.87 to 1.10; P=0.72) or in the rates of the components of the outcome, including repeat coronary revascularization, which was performed in 2.8% of the patients in the off-pump group and in 2.3% of the patients in the on-pump group (hazard ratio, 1.21; 95% CI, 0.85 to 1.73; P=0.29). The secondary outcome for the overall period of the trial - the mean cost in U.S. dollars per patient - also did not differ significantly between the off-pump group and the on-pump group ($15,107 and $14,992, respectively; between-group difference, $115; 95% CI, -$697 to $927). There were no significant between-group differences in quality-of-life measures.
In our trial, the rate of the composite outcome of death, stroke, myocardial infarction, renal failure, or repeat revascularization at 5 years of follow-up was similar among patients who underwent off-pump CABG and those who underwent on-pump CABG. (Funded by the Canadian Institutes of Health Research; CORONARY ClinicalTrials.gov number, NCT00463294 .).
我们之前报道过，在接受非体外循环冠状动脉旁路移植术（off-pump）和体外循环冠状动脉旁路移植术（on-pump）的患者中，30 天和 1 年时的死亡、中风、心肌梗死或肾衰竭复合结局发生率没有显著差异。我们现在报告 5 年（试验结束）时的结果。
共有来自 19 个国家的 4752 例冠状动脉疾病患者被随机分配接受 off-pump 或 on-pump CABG。本报告分析了死亡、中风、心肌梗死、肾衰竭或再次血运重建（CABG 或经皮冠状动脉介入治疗）的复合结局。平均随访时间为 4.8 年。
off-pump 组和 on-pump 组的复合结局发生率（分别为 23.1%和 23.6%；off-pump CABG 的危险比为 0.98；95%置信区间[CI]，0.87 至 1.10；P=0.72）或结局组成部分的发生率均无显著差异，包括再次血运重建，off-pump 组中有 2.8%的患者和 on-pump 组中有 2.3%的患者接受了该治疗（危险比，1.21；95%CI，0.85 至 1.73；P=0.29）。试验总期间的次要结局 - 每位患者的平均美元成本 - 两组间也无显著差异（分别为 15107 美元和 14992 美元；组间差异为 115 美元；95%CI，-697 美元至 927 美元）。两组间的生活质量测量也无显著差异。
在我们的试验中，接受 off-pump CABG 和 on-pump CABG 的患者在 5 年随访时的死亡、中风、心肌梗死、肾衰竭或再次血运重建的复合结局发生率相似。（由加拿大卫生研究院资助；CORONARY ClinicalTrials.gov 编号，NCT00463294）。
