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入院前远程缺血预处理作为经皮冠状动脉介入治疗的辅助手段,对急性心肌梗死患者心肌挽救的影响:一项随机试验。

Remote ischaemic conditioning before hospital admission, as a complement to angioplasty, and effect on myocardial salvage in patients with acute myocardial infarction: a randomised trial.

机构信息

Department of Cardiology, Aarhus University Hospital Skejby, Aarhus N, Denmark.

出版信息

Lancet. 2010 Feb 27;375(9716):727-34. doi: 10.1016/S0140-6736(09)62001-8.

Abstract

BACKGROUND

Remote ischaemic preconditioning attenuates cardiac injury at elective surgery and angioplasty. We tested the hypothesis that remote ischaemic conditioning during evolving ST-elevation myocardial infarction, and done before primary percutaneous coronary intervention, increases myocardial salvage.

METHODS

333 consecutive adult patients with a suspected first acute myocardial infarction were randomly assigned in a 1:1 ratio by computerised block randomisation to receive primary percutaneous coronary intervention with (n=166 patients) versus without (n=167) remote conditioning (intermittent arm ischaemia through four cycles of 5-min inflation and 5-min deflation of a blood-pressure cuff). Allocation was concealed with opaque sealed envelopes. Patients received remote conditioning during transport to hospital, and primary percutaneous coronary intervention in hospital. The primary endpoint was myocardial salvage index at 30 days after primary percutaneous coronary intervention, measured by myocardial perfusion imaging as the proportion of the area at risk salvaged by treatment; analysis was per protocol. This study is registered with ClinicalTrials.gov, number NCT00435266.

FINDINGS

82 patients were excluded on arrival at hospital because they did not meet inclusion criteria, 32 were lost to follow-up, and 77 did not complete the follow-up with data for salvage index. Median salvage index was 0.75 (IQR 0.50-0.93, n=73) in the remote conditioning group versus 0.55 (0.35-0.88, n=69) in the control group, with median difference of 0.10 (95% CI 0.01-0.22; p=0.0333); mean salvage index was 0.69 (SD 0.27) versus 0.57 (0.26), with mean difference of 0.12 (95% CI 0.01-0.21; p=0.0333). Major adverse coronary events were death (n=3 per group), reinfarction (n=1 per group), and heart failure (n=3 per group).

INTERPRETATION

Remote ischaemic conditioning before hospital admission increases myocardial salvage, and has a favourable safety profile. Our findings merit a larger trial to establish the effect of remote conditioning on clinical outcomes.

FUNDING

Fondation Leducq.

摘要

背景

远程缺血预处理可减轻择期手术和血管成形术中的心脏损伤。我们检验了这样一个假设,即在进展性 ST 段抬高型心肌梗死期间进行远程缺血预处理,并在进行直接经皮冠状动脉介入治疗之前进行,可以增加心肌挽救。

方法

333 例连续的成人疑似首次急性心肌梗死患者通过计算机化的块随机分组,按 1:1 的比例随机分配接受直接经皮冠状动脉介入治疗(n=166 例)与(n=167 例)远程预处理(通过四个 5 分钟充气和 5 分钟放气的血压袖带循环实现间歇性手臂缺血)。分配是用不透明的密封信封进行隐藏的。患者在送往医院的途中接受远程预处理,并在医院进行直接经皮冠状动脉介入治疗。主要终点是直接经皮冠状动脉介入治疗后 30 天的心肌挽救指数,通过心肌灌注成像测量,作为治疗挽救的危险区域的比例;分析是基于方案的。本研究在 ClinicalTrials.gov 上注册,编号为 NCT00435266。

结果

82 例患者因不符合纳入标准在抵达医院时被排除,32 例患者失访,77 例患者未完成随访,未提供挽救指数的数据。远程预处理组的中位挽救指数为 0.75(IQR 0.50-0.93,n=73),对照组为 0.55(0.35-0.88,n=69),中位数差异为 0.10(95%CI 0.01-0.22;p=0.0333);平均挽救指数分别为 0.69(SD 0.27)和 0.57(0.26),平均差异为 0.12(95%CI 0.01-0.21;p=0.0333)。主要不良冠状动脉事件包括死亡(每组 3 例)、再梗死(每组 1 例)和心力衰竭(每组 3 例)。

解释

在入院前进行远程缺血预处理可增加心肌挽救,且具有良好的安全性。我们的研究结果表明,需要进行更大规模的试验来确定远程预处理对临床结局的影响。

资金来源

Leducq 基金会。

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