Jeyaraman Maya M, Rabbani Rasheda, Copstein Leslie, Sulaiman Wasan, Farshidfar Farnaz, Kashani Hessam H, Qadar Sheikh M Z, Guan Qingdong, Skidmore Becky, Kardami Elissavet, Ducas John, Mansour Samer, Zarychanski Ryan, Abou-Setta Ahmed M
The George and Fay Yee Center for Healthcare Innovation, University of Manitoba, Winnipeg, Manitoba, Canada; Department of Community Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.
The George and Fay Yee Center for Healthcare Innovation, University of Manitoba, Winnipeg, Manitoba, Canada; Department of Community Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.
Can J Cardiol. 2017 Dec;33(12):1611-1623. doi: 10.1016/j.cjca.2017.10.001. Epub 2017 Oct 7.
Randomized controlled trials (RCTs) on bone marrow stem cell (BMSC) therapy in ST-elevation myocardial infarction (STEMI) patients have reported conflicting results. Our main objective was to critically appraise and meta-analyze best-available evidence on efficacy and safety of intracoronary administration of autologous BMSC therapy in STEMI patients after primary percutaneous coronary intervention.
We conducted a search of MEDLINE, PubMed, EMBASE, CENTRAL, Global Health, CINAHL, and conference proceedings in February 2017. Our primary outcome was all-cause mortality. Secondary and safety outcomes included cardiac death, heart failure, arrhythmias, repeat myocardial infarction, or target vessel revascularizations; or improved health-related quality of life, left ventricular ejection fraction, or infarct size. Summary relative and absolute risks were obtained using random effects models. We also evaluated the strength of evidence.
A comprehensive database search identified 42 RCTs (3365 STEMI patients). BMSC therapy did not significantly decrease mortality (risk ratio, 0.71; 95% confidence interval, 0.45-1.11; I, 0%; absolute risk reduction, 0.1%; 95% confidence interval, -0.71 to 0.91; 40 trials; 3289 participants; I, 0%; low strength of evidence). BMSC therapy had no effect on secondary or adverse outcomes. Trial sequential analysis for all-cause mortality showed no evidence of a clinically important difference, with a very low probability that future studies can change the current conclusion.
On the basis of evidence from 42 RCTs published in the past 15 years, we provide conclusive evidence for a lack of beneficial effect for autologous BMSC therapy in patients with STEMI.
关于骨髓干细胞(BMSC)治疗ST段抬高型心肌梗死(STEMI)患者的随机对照试验(RCT)报告了相互矛盾的结果。我们的主要目的是严格评估和荟萃分析关于在直接经皮冠状动脉介入治疗后,STEMI患者冠状动脉内给予自体BMSC治疗的疗效和安全性的最佳现有证据。
我们于2017年2月检索了MEDLINE、PubMed、EMBASE、CENTRAL、全球卫生、CINAHL以及会议论文集。我们的主要结局是全因死亡率。次要和安全性结局包括心源性死亡、心力衰竭、心律失常、再次心肌梗死或靶血管血运重建;或健康相关生活质量改善、左心室射血分数或梗死面积改善。使用随机效应模型获得汇总相对风险和绝对风险。我们还评估了证据的强度。
全面的数据库检索确定了42项RCT(3365例STEMI患者)。BMSC治疗未显著降低死亡率(风险比,0.71;95%置信区间,0.45 - 1.11;I²,0%;绝对风险降低,0.1%;95%置信区间, - 0.71至0.91;40项试验;3289名参与者;I²,0%;证据强度低)。BMSC治疗对次要或不良结局无影响。全因死亡率的序贯试验分析未显示有临床重要差异的证据,未来研究改变当前结论的可能性非常低。
基于过去15年发表的42项RCT的证据,我们提供了确凿证据,表明自体BMSC治疗对STEMI患者没有有益效果。