From the Hatter Cardiovascular Institute, University College London (D.J.H., L.C., M.X., D.M.Y.), the National Institute of Health Research University College London Hospitals Biomedical Research Centre (D.J.H., D.M.Y.), the Clinical Trials Unit, London School of Hygiene and Tropical Medicine (R.E., R.K., J.N., S.R., T.C.), the Nuffield Trust (C.A.), the Heart Hospital, University College London Hospital (S.K.); King's College London and King's College Hospital (G.K.); Royal Free Hospital (C.L.); and the National Institute of Health Research Cardiovascular Biomedical Research Unit at Royal Brompton and Harefield NHS Trust (J.P.), London, and Papworth Hospital, Cambridge (D.P.J.) - all in the United Kingdom; and the National Heart Research Institute Singapore, National Heart Centre Singapore (D.J.H.), and the Cardiovascular and Metabolic Disorders Program, Duke-National University of Singapore (D.J.H.) - both in Singapore.
N Engl J Med. 2015 Oct 8;373(15):1408-17. doi: 10.1056/NEJMoa1413534. Epub 2015 Oct 5.
Whether remote ischemic preconditioning (transient ischemia and reperfusion of the arm) can improve clinical outcomes in patients undergoing coronary-artery bypass graft (CABG) surgery is not known. We investigated this question in a randomized trial.
We conducted a multicenter, sham-controlled trial involving adults at increased surgical risk who were undergoing on-pump CABG (with or without valve surgery) with blood cardioplegia. After anesthesia induction and before surgical incision, patients were randomly assigned to remote ischemic preconditioning (four 5-minute inflations and deflations of a standard blood-pressure cuff on the upper arm) or sham conditioning (control group). Anesthetic management and perioperative care were not standardized. The combined primary end point was death from cardiovascular causes, nonfatal myocardial infarction, coronary revascularization, or stroke, assessed 12 months after randomization.
We enrolled a total of 1612 patients (811 in the control group and 801 in the ischemic-preconditioning group) at 30 cardiac surgery centers in the United Kingdom. There was no significant difference in the cumulative incidence of the primary end point at 12 months between the patients in the remote ischemic preconditioning group and those in the control group (212 patients [26.5%] and 225 patients [27.7%], respectively; hazard ratio with ischemic preconditioning, 0.95; 95% confidence interval, 0.79 to 1.15; P=0.58). Furthermore, there were no significant between-group differences in either adverse events or the secondary end points of perioperative myocardial injury (assessed on the basis of the area under the curve for the high-sensitivity assay of serum troponin T at 72 hours), inotrope score (calculated from the maximum dose of the individual inotropic agents administered in the first 3 days after surgery), acute kidney injury, duration of stay in the intensive care unit and hospital, distance on the 6-minute walk test, and quality of life.
Remote ischemic preconditioning did not improve clinical outcomes in patients undergoing elective on-pump CABG with or without valve surgery. (Funded by the Efficacy and Mechanism Evaluation Program [a Medical Research Council and National Institute of Health Research partnership] and the British Heart Foundation; ERICCA ClinicalTrials.gov number, NCT01247545.).
在接受冠状动脉旁路移植术(CABG)的患者中,远程缺血预处理(手臂的短暂缺血再灌注)是否能改善临床结局尚不清楚。我们在一项随机试验中对此进行了研究。
我们进行了一项多中心、假对照试验,纳入了接受体外循环 CABG(伴或不伴瓣膜手术)和含血停搏液的高危成人患者。在麻醉诱导后、手术切口前,患者被随机分配至远程缺血预处理(4 次 5 分钟的标准血压袖带充气和放气)或假处理(对照组)。麻醉管理和围手术期护理未标准化。联合主要终点为随机分组后 12 个月时心血管原因导致的死亡、非致死性心肌梗死、冠状动脉血运重建或卒中。
我们在英国 30 家心脏手术中心共纳入了 1612 例患者(对照组 811 例,缺血预处理组 801 例)。缺血预处理组和对照组患者 12 个月时的主要终点累积发生率无显著差异(分别为 212 例[26.5%]和 225 例[27.7%];缺血预处理的危险比为 0.95;95%置信区间为 0.79 至 1.15;P=0.58)。此外,两组之间的不良事件或围手术期心肌损伤(基于高敏肌钙蛋白 T 检测曲线下面积在术后 72 小时评估)、正性肌力药物评分(术后前 3 天给予的每种正性肌力药物的最大剂量计算)、急性肾损伤、重症监护病房和医院停留时间、6 分钟步行测试距离和生活质量等次要终点也无显著差异。
在接受择期体外循环 CABG 术伴或不伴瓣膜手术的患者中,远程缺血预处理并未改善临床结局。(由疗效和机制评估计划(医学研究理事会和英国国家健康研究所的合作项目)和英国心脏基金会资助;ERICCA 临床试验.gov 编号:NCT01247545。)