Limalanathan Shanmuganathan, Andersen Geir Ø, Kløw Nils-Einar, Abdelnoor Michael, Hoffmann Pavel, Eritsland Jan
Center for Heart Failure Research, University of Oslo, Oslo, Norway.
J Am Heart Assoc. 2014 Apr 23;3(2):e000679. doi: 10.1161/JAHA.113.000679.
Reduction of infarct size by ischemic postconditioning (IPost) has been reported in smaller proof-of-concept clinical studies, but has not been confirmed in other smaller studies. The principle needs to be evaluated in larger groups of ST-elevation myocardial infarction (STEMI) patients before being implemented in clinical practice. This study assessed the effect of ischemic postcoditioning (IPost) on infarct size in patients with STEMI treated by primary percutaneous coronary intervention (PCI).
Patients with first-time STEMI, <6 hours from symptom onset, referred to primary PCI were randomized to IPost or control groups. IPost was administered by 4 cycles of 1-minute reocclusion and 1-minute reperfusion, starting 1 minute after opening, followed by stenting. In the control group, stenting was performed immediately after reperfusion. The primary endpoint was infarct size measured by cardiac magnetic resonance after 4 months. A total of 272 patients were randomized. Infarct size (percent of left ventricular mass) after 4 months (median values and interquartile range) was 14.4% (7.7, 24.6) and 13.5% (8.1, 19.3) in the control group and IPost group, respectively (P=0.18). No significant impact of IPost was found when controlling for baseline risk factors of infarct size in a multivariate linear regression model (P=0.16). The effects of IPost on secondary endpoints, including markers of necrosis, myocardial salvage, and ejection fraction, as well as adverse cardiac events during follow-up, were consistently neutral.
In contrast to several smaller trials reported previously, we found no significant effects of IPost on infarct size or secondary study outcomes.
http://www.clinicaltrials.gov Unique identifier: NCT.No.PO1506.
在一些规模较小的概念验证临床研究中，已报道缺血后处理（IPost）可缩小梗死面积，但在其他一些较小规模研究中尚未得到证实。在临床实践中应用该原理之前，需要在更大规模的ST段抬高型心肌梗死（STEMI）患者群体中进行评估。本研究评估了缺血后处理（IPost）对接受直接经皮冠状动脉介入治疗（PCI）的STEMI患者梗死面积的影响。
首次发生STEMI且症状发作后<6小时并接受直接PCI的患者被随机分为IPost组或对照组。IPost在开通后1分钟开始，通过4个周期的1分钟再闭塞和1分钟再灌注进行，随后进行支架置入。在对照组中，再灌注后立即进行支架置入。主要终点是4个月后通过心脏磁共振测量的梗死面积。共有272例患者被随机分组。4个月后对照组和IPost组的梗死面积（左心室质量百分比，中位数和四分位间距）分别为14.4%（7.7，24.6）和13.5%（8.1，19.3）（P=0.18）。在多变量线性回归模型中，在控制梗死面积的基线风险因素时，未发现IPost有显著影响（P=0.16）。IPost对次要终点的影响，包括坏死标志物、心肌挽救和射血分数，以及随访期间的不良心脏事件，始终为中性。
与先前报道的几项较小规模试验不同，我们发现IPost对梗死面积或次要研究结果没有显著影响。
http://www.clinicaltrials.gov 唯一标识符：NCT.No.PO1506
