Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, ON, Canada.
N Engl J Med. 2012 Apr 19;366(16):1489-97. doi: 10.1056/NEJMoa1200388. Epub 2012 Mar 26.
The relative benefits and risks of performing coronary-artery bypass grafting (CABG) with a beating-heart technique (off-pump CABG), as compared with cardiopulmonary bypass (on-pump CABG), are not clearly established.
At 79 centers in 19 countries, we randomly assigned 4752 patients in whom CABG was planned to undergo the procedure off-pump or on-pump. The first coprimary outcome was a composite of death, nonfatal stroke, nonfatal myocardial infarction, or new renal failure requiring dialysis at 30 days after randomization.
There was no significant difference in the rate of the primary composite outcome between off-pump and on-pump CABG (9.8% vs. 10.3%; hazard ratio for the off-pump group, 0.95; 95% confidence interval [CI], 0.79 to 1.14; P=0.59) or in any of its individual components. The use of off-pump CABG, as compared with on-pump CABG, significantly reduced the rates of blood-product transfusion (50.7% vs. 63.3%; relative risk, 0.80; 95% CI, 0.75 to 0.85; P<0.001), reoperation for perioperative bleeding (1.4% vs. 2.4%; relative risk, 0.61; 95% CI, 0.40 to 0.93; P=0.02), acute kidney injury (28.0% vs. 32.1%; relative risk, 0.87; 95% CI, 0.80 to 0.96; P=0.01), and respiratory complications (5.9% vs. 7.5%; relative risk, 0.79; 95% CI, 0.63 to 0.98; P=0.03) but increased the rate of early repeat revascularizations (0.7% vs. 0.2%; hazard ratio, 4.01; 95% CI, 1.34 to 12.0; P=0.01).
There was no significant difference between off-pump and on-pump CABG with respect to the 30-day rate of death, myocardial infarction, stroke, or renal failure requiring dialysis. The use of off-pump CABG resulted in reduced rates of transfusion, reoperation for perioperative bleeding, respiratory complications, and acute kidney injury but also resulted in an increased risk of early revascularization. (Funded by the Canadian Institutes of Health Research; CORONARY ClinicalTrials.gov number, NCT00463294.).
与体外循环(on-pump,即使用心肺机)下进行冠状动脉旁路移植术(CABG)相比,心脏不停跳技术(off-pump CABG)的相对益处和风险尚不明确。
在 19 个国家的 79 个中心,我们将计划进行 CABG 的 4752 例患者随机分配至 off-pump 或 on-pump 组。主要复合终点为随机分组后 30 天内死亡、非致死性卒、非致死性心肌梗死或新出现需要透析的肾功能衰竭。
off-pump CABG 与 on-pump CABG 的主要复合终点发生率无显著差异(9.8% vs. 10.3%;off-pump 组的危险比为 0.95;95%置信区间[CI]为 0.79 至 1.14;P=0.59),或任何单一终点发生率也无显著差异。与 on-pump CABG 相比,off-pump CABG 可显著降低输血率(50.7% vs. 63.3%;相对风险,0.80;95%CI,0.75 至 0.85;P<0.001)、围术期出血需再次手术率(1.4% vs. 2.4%;相对风险,0.61;95%CI,0.40 至 0.93;P=0.02)、急性肾损伤发生率(28.0% vs. 32.1%;相对风险,0.87;95%CI,0.80 至 0.96;P=0.01)和呼吸系统并发症发生率(5.9% vs. 7.5%;相对风险,0.79;95%CI,0.63 至 0.98;P=0.03),但增加了早期再次血运重建率(0.7% vs. 0.2%;危险比,4.01;95%CI,1.34 至 12.0;P=0.01)。
off-pump CABG 与 on-pump CABG 在 30 天死亡率、心肌梗死、卒中和需要透析的肾衰竭发生率方面无显著差异。off-pump CABG 可降低输血、围术期出血需再次手术、呼吸系统并发症和急性肾损伤发生率,但增加了早期再次血运重建的风险。(加拿大卫生研究院资助;CORONARY ClinicalTrials.gov 注册号:NCT00463294。)