Herz- und Gefäß-Klinik Bad Neustadt, Bad Neustadt, Germany.
N Engl J Med. 2013 Mar 28;368(13):1189-98. doi: 10.1056/NEJMoa1211666. Epub 2013 Mar 11.
The benefits of coronary-artery bypass grafting (CABG) without cardiopulmonary bypass in the elderly are still undetermined.
We randomly assigned patients 75 years of age or older who were scheduled for elective first-time CABG to undergo the procedure either without cardiopulmonary bypass (off-pump CABG) or with it (on-pump CABG). The primary end point was a composite of death, stroke, myocardial infarction, repeat revascularization, or new renal-replacement therapy at 30 days and at 12 months after surgery.
A total of 2539 patients underwent randomization. At 30 days after surgery, there was no significant difference between patients who underwent off-pump surgery and those who underwent on-pump surgery in terms of the composite outcome (7.8% vs. 8.2%; odds ratio, 0.95; 95% confidence interval [CI], 0.71 to 1.28; P=0.74) or four of the components (death, stroke, myocardial infarction, or new renal-replacement therapy). Repeat revascularization occurred more frequently after off-pump CABG than after on-pump CABG (1.3% vs. 0.4%; odds ratio, 2.42; 95% CI, 1.03 to 5.72; P=0.04). At 12 months, there was no significant between-group difference in the composite end point (13.1% vs. 14.0%; hazard ratio, 0.93; 95% CI, 0.76 to 1.16; P=0.48) or in any of the individual components. Similar results were obtained in a per-protocol analysis that excluded the 177 patients who crossed over from the assigned treatment to the other treatment.
In patients 75 years of age or older, there was no significant difference between on-pump and off-pump CABG with regard to the composite outcome of death, stroke, myocardial infarction, repeat revascularization, or new renal-replacement therapy within 30 days and within 12 months after surgery. (Funded by Maquet; GOPCABE ClinicalTrials.gov number, NCT00719667.).
在老年人中，不经体外循环的冠状动脉旁路移植术（CABG）的益处仍不确定。
我们将计划接受首次择期 CABG 的 75 岁或以上的患者随机分为两组，一组接受不经体外循环（非体外循环 CABG）的手术，另一组接受经体外循环（体外循环 CABG）的手术。主要终点是手术后 30 天和 12 个月时死亡、中风、心肌梗死、再次血运重建或新的肾脏替代治疗的复合结果。
共有 2539 名患者接受了随机分组。手术后 30 天，非体外循环手术组和体外循环手术组在复合结果（7.8%对 8.2%；比值比，0.95；95%置信区间[CI]，0.71 至 1.28；P=0.74）或四个组成部分（死亡、中风、心肌梗死或新的肾脏替代治疗）方面没有显著差异。非体外循环 CABG 后再次血运重建的发生率高于体外循环 CABG（1.3%对 0.4%；比值比，2.42；95%CI，1.03 至 5.72；P=0.04）。在 12 个月时，两组在复合终点（13.1%对 14.0%；风险比，0.93；95%CI，0.76 至 1.16；P=0.48）或任何单个组成部分方面均无显著差异。在排除从指定治疗转为其他治疗的 177 名患者的意向治疗分析中，也得到了类似的结果。
在 75 岁或以上的患者中，与体外循环 CABG 相比，非体外循环 CABG 在术后 30 天和 12 个月内的死亡、中风、心肌梗死、再次血运重建或新的肾脏替代治疗的复合结果方面没有显著差异。（由 Maquet 资助；GOPCABE ClinicalTrials.gov 编号，NCT00719667。）
