Abdelnoor M, Sandven I, Limalanathan S, Eritsland J
Centre of Epidemiology and Biostatistics, Oslo University Hospital, Ullevål, Norway ; Centre of Clinical Heart Research, Oslo University Hospital, Ullevål, Norway.
Centre of Epidemiology and Biostatistics, Oslo University Hospital, Ullevål, Norway.
Vasc Health Risk Manag. 2014 Aug 8;10:477-91. doi: 10.2147/VHRM.S67154. eCollection 2014.
We aimed to summarize the evidence from randomized clinical trials studies examining the efficacy of ischemic postconditioning (IPost) in ST-elevation myocardial infarction.
The study was a systematic review and critical appraisal, with meta-analysis of randomized clinical trials.
We searched the literature. A total of 21 randomized clinical trials were identified. Both fixed effect and random effects models were used to synthesize the results of individual studies. Heterogeneity between studies was examined by subgroup and random effects meta-regression analyses, considering ptient-related and study-level variables. Publication bias, or "small-study effect", was evaluated.
Substantial heterogeneity was present. The random effects model pooled estimate for the outcome infarct size assessed by cardiac magnetic resonance was estimated by the standardized mean difference (SMD) =-0.06, 95% confidence interval (CI): -0.34 to 0.21, ie, no effect of IPost. For the end point infarct size, estimated by biomarkers of myocardial necrosis, an overall pooled effect was SMD =-0.58, 95% CI: -0.96 to -0.19. This effect disappeared in powered and nonbiased studies (SMD =0.03, 95% CI: -0.48 to 0.55). Finally, for the outcome left ventricular ejection fraction, SMD =0.47 95% CI: 0.20 to 0.74. Unfortunately, selection bias (small-study effect) was present. For this outcome, the meta-regression showed that both presence of hypertension and the inclusion of nonbiased studies explained 28.3% of the heterogeneity among the studies. Simulation by the "trim and fill" method, which controlled for selection bias using random effects model, diluted the effect (SMD =0.17 95% CI: -0.13 to 0.48). No effects by IPost on ST-segment resolution or on the majority of adverse clinical events were observed during follow up, except the incidence of congestive heart failure was found.
Evidence from this study suggests no cardioprotection from IPost, on surrogate and the majority of clinical end points. A possible beneficial effect on the incidence of congestive heart failure needs to be replicated by a large clinical trial.
我们旨在总结随机临床试验研究中的证据,这些研究探讨了缺血后适应(IPost)在ST段抬高型心肌梗死中的疗效。
该研究为系统评价和批判性评估,并对随机临床试验进行荟萃分析。
我们检索了文献。共识别出21项随机临床试验。采用固定效应模型和随机效应模型来综合各研究结果。通过亚组分析和随机效应荟萃回归分析检查研究间的异质性,同时考虑患者相关变量和研究水平变量。评估发表偏倚或“小研究效应”。
存在显著异质性。通过心脏磁共振评估的梗死面积这一结局的随机效应模型合并估计值,标准化均数差(SMD)=-0.06,95%置信区间(CI):-0.34至0.21,即IPost无效应。对于通过心肌坏死生物标志物估计的梗死面积终点,总体合并效应为SMD=-0.58,95%CI:-0.96至-0.19。在有足够样本量且无偏倚的研究中该效应消失(SMD=0.03,95%CI:-0.48至0.55)。最后,对于左心室射血分数这一结局,SMD=0.47,95%CI:0.20至0.74。遗憾的是存在选择偏倚(小研究效应)。对于该结局,荟萃回归显示高血压的存在和纳入无偏倚研究解释了研究间28.3%的异质性。采用“修剪和填充法”进行模拟,该方法使用随机效应模型控制选择偏倚,使效应减弱(SMD=0.17,95%CI:-0.13至0.48)。随访期间未观察到IPost对ST段回落或大多数不良临床事件有影响,但发现了充血性心力衰竭的发生率。
本研究的证据表明,IPost在替代指标和大多数临床终点方面无心脏保护作用。对充血性心力衰竭发生率可能的有益影响需要通过大型临床试验进行验证。