The Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, ON, Canada.
N Engl J Med. 2013 Mar 28;368(13):1179-88. doi: 10.1056/NEJMoa1301228. Epub 2013 Mar 11.
Previously, we reported that there was no significant difference at 30 days in the rate of a primary composite outcome of death, myocardial infarction, stroke, or new renal failure requiring dialysis 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 results on quality of life and cognitive function and on clinical outcomes at 1 year.
We enrolled 4752 patients with coronary artery disease who were scheduled to undergo CABG and randomly assigned them to undergo the procedure off-pump or on-pump. Patients were enrolled at 79 centers in 19 countries. We assessed quality of life and cognitive function at discharge, at 30 days, and at 1 year and clinical outcomes at 1 year.
At 1 year, there was no significant difference in the rate of the primary composite outcome between off-pump and on-pump CABG (12.1% and 13.3%, respectively; hazard ratio with off-pump CABG, 0.91; 95% confidence interval [CI], 0.77 to 1.07; P=0.24). The rate of the primary outcome was also similar in the two groups in the period between 31 days and 1 year (hazard ratio, 0.79; 95% CI, 0.55 to 1.13; P=0.19). The rate of repeat coronary revascularization at 1 year was 1.4% in the off-pump group and 0.8% in the on-pump group (hazard ratio, 1.66; 95% CI, 0.95 to 2.89; P=0.07). There were no significant differences between the two groups at 1 year in measures of quality of life or neurocognitive function.
At 1 year after CABG, there was no significant difference between off-pump and on-pump CABG with respect to the primary composite outcome, the rate of repeat coronary revascularization, quality of life, or neurocognitive function. (Funded by the Canadian Institutes of Health Research; CORONARY ClinicalTrials.gov number, NCT00463294.).
此前,我们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 天主要复合终点(死亡、心肌梗死、卒中和新需要透析的肾衰竭)的发生率没有显著差异。我们现在报告 1 年时的生活质量和认知功能以及临床结果。
我们纳入了 4752 例计划接受冠状动脉旁路移植术的冠状动脉疾病患者,并将其随机分为非体外循环组或体外循环组。患者在 19 个国家的 79 个中心被纳入研究。我们在出院时、30 天时和 1 年时评估生活质量和认知功能,并在 1 年时评估临床结局。
1 年时,非体外循环组和体外循环组的主要复合结局发生率无显著差异(分别为 12.1%和 13.3%,非体外循环组的风险比为 0.91;95%置信区间为 0.77 至 1.07;P=0.24)。两组在 31 天至 1 年期间的主要结局发生率也相似(风险比为 0.79;95%置信区间为 0.55 至 1.13;P=0.19)。1 年时,非体外循环组的再次冠状动脉血运重建率为 1.4%,体外循环组为 0.8%(风险比为 1.66;95%置信区间为 0.95 至 2.89;P=0.07)。两组在 1 年时的生活质量或神经认知功能测量指标均无显著差异。
在冠状动脉旁路移植术后 1 年,非体外循环和体外循环冠状动脉旁路移植术在主要复合结局、再次冠状动脉血运重建率、生活质量或神经认知功能方面均无显著差异。(由加拿大卫生研究院资助;CORONARY ClinicalTrials.gov 编号,NCT00463294。)