Área del Corazón del Hospital Clínico Universitario Virgen de la Victoria, Fundación IMABIS, RECAVA, Málaga, Spain.
Heart. 2013 Oct;99(19):1431-7. doi: 10.1136/heartjnl-2013-304172. Epub 2013 Jul 12.
Determine whether remote ischaemic postconditioning (RIP) protects against percutaneous coronary intervention-related myocardial infarction (PCI-MI).
Single-centre, randomised, blinded to the researchers, clinical trial. ClinicalTrials.gov (NCT 01113008).
Tertiary hospital centre.
232 patients underwent elective PCI for stable or unstable angina.
Patients were randomised to RIP (induction of three 5-min cycles of ischaemia in the arm after the PCI) versus placebo.
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.
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).
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.
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)。
单中心、随机、研究者设盲、临床试验。ClinicalTrials.gov(NCT 01113008)。
三级医院中心。
232 名接受稳定或不稳定型心绞痛择期 PCI 的患者。
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。
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)。
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。