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[Lancet在线发表]: 远处缺血处理对急性心梗患者临床预后的影响
2019年11月03日 时讯速递, 进展交流 暂无评论

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Effect of remote ischaemic conditioning on clinical outcomes in patients with acute myocardial infarction (CONDI-2/ERIC-PPCI): a single-blind randomised controlled trial

Derek J Hausenloy, Rajesh K Kharbanda, Ulla Kristine Møller, et al.

Lancet Published:September 06, 2019 DOI:https://doi.org/10.1016/S0140-6736(19)32039-2

Summary

Background 背景

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.

远处缺血处理(对上肢实施一过性缺血和再灌注)能够减少接受原发PCI的STEMI患者心肌梗死面积。我们研究远处缺血处理能否降低12个月时心源性死亡及心衰住院的风险。

Methods 方法

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.

我们在英国、丹麦、西班牙和塞尔维亚的33个中心进行了一项国际性、研究者发起的、前瞻、单盲、随机对照试验 (CONDI-2/ERIC-PPCI)。因怀疑STEMI而接受PPCI的年龄> 18岁患者接受随机分组(1:1,采用置换区组法根据中心进行分层),分别接受标准治疗(包括假的模拟远处缺血处理干预,仅在英国中心进行),或远处缺血处理治疗(对上肢实施间断缺血和再灌注,通过袖带自动充气装置每次5分钟充气,5分钟放气,共4个循环)。治疗分组对负责收集数据和评估结局的研究者隐藏。主要复合终点为意向治疗人群12个月时心源性死亡或因心衰住院。试验在ClinicalTrials.gov注册,注册号NCT02342522

Findings 结果

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.

2013年11月6日至2018年3月31日间,共有5401名患者随机分至对照组(n=2701) 或远处缺血处理组(n=2700)。根据到达医院时情况及失访情况进行排除后,共有2569名患者纳入对照组,2546名患者纳入干预组,且最终进入意向治疗分析。PPCI后12个月时,心源性死亡或心衰住院(主要预后终点)的Kaplan-Meier曲线显示,对照组220名患者 (8·6%) 及远处缺血处理组239名患者 (9·4%)满足主要预后终点(风险比 1·10 [95% CI 0·91–1·32],干预vs. 对照 p=0·32)。远处缺血处理未观察到重要的意外不良事件或副作用。

Interpretation 结论

Remote ischaemic conditioning does not improve clinical outcomes (cardiac death or hospitalisation for heart failure) at 12 months in patients with STEMI undergoing PPCI.

对于接受PPCI的STEMI患者而言,远处缺血处理不能改善12个月时的临床预后(心源性死亡或因心衰住院)。

Funding 资助

British Heart Foundation, University College London Hospitals/University College London Biomedical Research Centre, Danish Innovation Foundation, Novo Nordisk Foundation, TrygFonden.

评论[仅代表个人观点]

  • 从道理上讲,其实没有想明白,STEMI发生后的远处缺血处理为何会有效?毕竟PCI的作用是开通血管而非造成进一步缺血
  • 德国Zarbock等对于拟接受增强CT的患者进行远处缺血预处理,发现造影剂肾病发生率显著降低。这个试验虽然尚未得到其他研究者的验证,但是,从道理上是讲得通的

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