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远程缺血后处理:在经皮冠状动脉血运重建中是否能预防缺血损伤?随机安慰剂对照临床试验。

Remote ischaemic postconditioning: does it protect against ischaemic damage in percutaneous coronary revascularisation? Randomised placebo-controlled clinical trial.

机构信息

Área del Corazón del Hospital Clínico Universitario Virgen de la Victoria, Fundación IMABIS, RECAVA, Málaga, Spain.

出版信息

Heart. 2013 Oct;99(19):1431-7. doi: 10.1136/heartjnl-2013-304172. Epub 2013 Jul 12.

DOI:10.1136/heartjnl-2013-304172
PMID:23850844
Abstract

OBJECTIVE

Determine whether remote ischaemic postconditioning (RIP) protects against percutaneous coronary intervention-related myocardial infarction (PCI-MI).

DESIGN

Single-centre, randomised, blinded to the researchers, clinical trial. ClinicalTrials.gov (NCT 01113008).

SETTING

Tertiary hospital centre.

PATIENTS

232 patients underwent elective PCI for stable or unstable angina.

INTERVENTIONS

Patients were randomised to RIP (induction of three 5-min cycles of ischaemia in the arm after the PCI) versus placebo.

MAIN OUTCOME MEASURES

The primary outcome measure was the peak 24-h troponin I level. PCI-MI was defined by an elevation of troponin values >3 or >5 of the 99th percentile according to the classical or the new definition. The secondary outcome measure was hospital admission, PCI for stable angina or acute coronary syndrome and mortality after 1 year of follow-up. The use of RIP in diabetic patients was specifically studied.

RESULTS

The mean age was 64.6 years, and 42% were diabetic. The peak troponin in the RIP patients was 0.476 vs 0.478 ng/mL (p=0.99). PCI-MI occurred in 36% of the RIP patients versus 30.8% in the placebo group (p=0.378). Diabetic RIP patients had more PCI-MI (new definition): OR 2.7; 95% CI 1.10 to 6.92; p=0.027. The secondary outcome measure was seen in 11.7% of the RIP patients versus 10.8% in the placebo group (p=0.907).

CONCLUSIONS

RIP did not reduce the damage associated with elective PCI or cardiovascular events during the follow-up. The diabetic population who underwent RIP had more PCI-MI.

摘要

目的

确定远程缺血后处理(RIP)是否能预防经皮冠状动脉介入治疗相关心肌梗死(PCI-MI)。

设计

单中心、随机、研究者设盲、临床试验。ClinicalTrials.gov(NCT 01113008)。

地点

三级医院中心。

患者

232 名接受稳定或不稳定型心绞痛择期 PCI 的患者。

干预措施

患者被随机分为 RIP(PCI 后手臂进行三个 5 分钟的缺血循环)组或安慰剂组。

主要观察指标

主要观察指标是 24 小时内肌钙蛋白 I 峰值水平。根据经典或新定义,PCI-MI 定义为肌钙蛋白值升高超过第 99 百分位的 3 倍或 5 倍。次要观察指标是住院、因稳定型心绞痛或急性冠脉综合征而行 PCI 以及 1 年随访后的死亡率。特别研究了 RIP 在糖尿病患者中的应用。

结果

平均年龄为 64.6 岁,42%为糖尿病患者。RIP 患者的肌钙蛋白峰值为 0.476 比 0.478ng/mL(p=0.99)。RIP 组患者发生 36%的 PCI-MI,安慰剂组为 30.8%(p=0.378)。糖尿病 RIP 患者发生更多的 PCI-MI(新定义):OR 2.7;95%CI 1.10 至 6.92;p=0.027。次要观察指标在 RIP 组中为 11.7%,安慰剂组为 10.8%(p=0.907)。

结论

RIP 不能减少择期 PCI 相关的损伤或随访期间的心血管事件。接受 RIP 的糖尿病患者发生更多的 PCI-MI。

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