BACKGROUND Remote ischaemic conditioning with transient ischaemia and reperfusion applied to the arm has been shown to reduce myocardial infarct size in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). We investigated whether remote ischaemic conditioning could reduce the incidence of cardiac death and hospitalisation for heart failure at 12 months. METHODS We did an international investigator-initiated, prospective, single-blind, randomised controlled trial (CONDI-2/ERIC-PPCI) at 33 centres across the UK, Denmark, Spain, and Serbia. Patients (age >18 years) with suspected STEMI and who were eligible for PPCI were randomly allocated (1:1, stratified by centre with a permuted block method) to receive standard treatment (including a sham simulated remote ischaemic conditioning intervention at UK sites only) or remote ischaemic conditioning treatment (intermittent ischaemia and reperfusion applied to the arm through four cycles of 5-min inflation and 5-min deflation of an automated cuff device) before PPCI. Investigators responsible for data collection and outcome assessment were masked to treatment allocation. The primary combined endpoint was cardiac death or hospitalisation for heart failure at 12 months in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT02342522) and is completed. FINDINGS Between Nov 6, 2013, and March 31, 2018, 5401 patients were randomly allocated to either the control group (n=2701) or the remote ischaemic conditioning group (n=2700). After exclusion of patients upon hospital arrival or loss to follow-up, 2569 patients in the control group and 2546 in the intervention group were included in the intention-to-treat analysis. At 12 months post-PPCI, the Kaplan-Meier-estimated frequencies of cardiac death or hospitalisation for heart failure (the primary endpoint) were 220 (8·6%) patients in the control group and 239 (9·4%) in the remote ischaemic conditioning group (hazard ratio 1·10 [95% CI 0·91-1·32], p=0·32 for intervention versus control). No important unexpected adverse events or side effects of remote ischaemic conditioning were observed. INTERPRETATION Remote ischaemic conditioning does not improve clinical outcomes (cardiac death or hospitalisation for heart failure) at 12 months in patients with STEMI undergoing PPCI. FUNDING British Heart Foundation, University College London Hospitals/University College London Biomedical Research Centre, Danish Innovation Foundation, Novo Nordisk Foundation, TrygFonden.

中文翻译：

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远程缺血调节对急性心肌梗死患者临床结局的影响 (CONDI-2/ERIC-PPCI)：一项单盲随机对照试验。

背景技术 已经证明，对手臂进行短暂性缺血和再灌注的远程缺血调节可减少接受直接经皮冠状动脉介入治疗 (PPCI) 的 ST 段抬高心肌梗死 (STEMI) 患者的心肌梗死面积。我们调查了远程缺血调节是否可以降低 12 个月时因心源性死亡和因心力衰竭住院的发生率。方法 我们在英国、丹麦、西班牙和塞尔维亚的 33 个中心进行了一项由国际研究者发起的前瞻性、单盲、随机对照试验 (CONDI-2/ERIC-PPCI)。疑似 STEMI 且符合 PPCI 条件的患者（年龄 >18 岁）被随机分配（1:1，按中心分层，采用置换阻滞法）接受标准治疗（包括仅在英国站点进行的假模拟远程缺血调节干预）或远程缺血调节治疗（间歇性缺血和再灌注，通过四个周期的 5 分钟充气和PPCI 前自动袖带装置放气 5 分钟）。负责数据收集和结果评估的调查人员对治疗分配不知情。主要联合终点是意向治疗人群在 12 个月时的心源性死亡或因心力衰竭住院。该试验已在 ClinicalTrials.gov (NCT02342522) 注册并已完成。2013 年 11 月 6 日至 2018 年 3 月 31 日期间的调查结果，5401 名患者被随机分配到对照组 (n=2701) 或远程缺血调节组 (n=2700)。在排除入院或失访患者后，对照组 2569 名患者和干预组 2546 名患者被纳入意向治疗分析。在 PPCI 后 12 个月，Kaplan-Meier 估计的心脏死亡或心力衰竭住院频率（主要终点）为对照组 220 例 (8·6%) 患者和对照组 239 例 (9·4%)远程缺血调节组（风险比 1·10 [95% CI 0·91-1·32]，p=0·32 干预与控制）。没有观察到重要的意外不良事件或远程缺血调节的副作用。解释 对于接受 PPCI 的 STEMI 患者，在 12 个月时，远程缺血调节不会改善临床结果（心源性死亡或因心力衰竭住院）。资助 英国心脏基金会、伦敦大学学院医院/伦敦大学学院生物医学研究中心、丹麦创新基金会、诺和诺德基金会、TrygFonden。