Meta-Analysis of Cell-based CaRdiac stUdiEs (ACCRUE) in patients with acute myocardial infarction based on individual patient data.
Meta-Analysis of Cell-based CaRdiac stUdiEs (ACCRUE) in patients with acute myocardial infarction based on individual patient data.
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DOI：
10.1161/circresaha.116.304346
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发表时间：
2015-04-10
影响因子：
20.1
通讯作者：
ACCRUE Investigators
中科院分区：
文献类型：
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作者：
Gyöngyösi M;Wojakowski W;Lemarchand P;Lunde K;Tendera M;Bartunek J;Marban E;Assmus B;Henry TD;Traverse JH;Moyé LA;Sürder D;Corti R;Huikuri H;Miettinen J;Wöhrle J;Obradovic S;Roncalli J;Malliaras K;Pokushalov E;Romanov A;Kastrup J;Bergmann MW;Atsma DE;Diederichsen A;Edes I;Benedek I;Benedek T;Pejkov H;Nyolczas N;Pavo N;Bergler-Klein J;Pavo IJ;Sylven C;Berti S;Navarese EP;Maurer G;ACCRUE Investigators
Acrue(基于细胞的心脏研究的荟萃分析)是第一个前瞻性宣布的合作多国数据库，包括接受细胞治疗的缺血性心脏病(IPD)患者的个人数据。我们分析了12个随机试验(Astai、Aalst、Boost、Bonami、Caduceus、FINCELL、Regent、Repair-AMI、SCMI、Swiss-AMI、Time、Late-Time；n=1252)中的IPDS在急性心肌梗死(AMI)后冠状动脉内治疗的安全性和有效性。主要终点是避免合并的主要不良心脑血管事件(MACCE；包括全因死亡、再梗死、中风和靶血管再血管化)。次要终点是摆脱硬临床终点(死亡、再心肌梗死或中风)，通过随机效应荟萃分析和交互作用的COX回归进行评估。次要疗效终点包括舒张末容量(ΔEDV)、收缩末期容量(ΔESV)和射血分数(ΔEF)的变化，采用随机效应荟萃分析和协方差分析。我们报告了细胞治疗组和对照组之间的加权平均差异。与对照组相比，细胞治疗对MACCE(14.0%比16.3%，风险比0.86，95%CI：0.63；1.18)、死亡(1.4%比2.1%)或死亡/再梗死/卒中(2.9%比4.7%)没有影响。与对照组相比，ΔEF(平均差值：0.96%，95%CI：−0.2；2.1)、ΔEDV或ΔESV没有变化。这些结果不受前壁心肌梗死部位、基线EF降低或使用MRI评估左心室参数的影响。这项对近期急性心肌梗死患者进行的随机试验对IPD的荟萃分析显示，就临床事件或左心功能的改变而言，冠状动脉内细胞疗法没有提供任何益处。
The ACCRUE (Meta-Analysis of Cell-based CaRdiac stUdiEs) is the first prospectively declared collaborative multinational database including individual data of patients (IPD) with ischemic heart disease treated with cell therapy. We analyzed the safety and efficacy of intracoronary cell therapy after acute myocardial infarction (AMI) including IPDs from 12 randomized trials (ASTAMI, Aalst, BOOST, BONAMI, CADUCEUS, FINCELL, REGENT, REPAIR-AMI, SCAMI, SWISS-AMI, TIME, LATE-TIME; n=1252). The primary endpoint was freedom from combined major adverse cardiac and cerebrovascular events (MACCE; including all-cause death, re-AMI, stroke, and target vessel revascularization). The secondary endpoint was freedom from hard clinical endpoints (death, re-AMI, or stroke), assessed with random-effects meta-analyses and Cox regressions for interactions. Secondary efficacy endpoints included changes in end-diastolic volume (ΔEDV), end-systolic volume (ΔESV), and ejection fraction (ΔEF), analyzed with random-effects meta-analyses and analysis of covariance. We reported weighted mean differences between cell therapy and control groups. No effect of cell therapy on MACCE (14.0% vs. 16.3%, hazard ratio 0.86, 95%CI: 0.63;1.18) or death (1.4% vs 2.1%) or death/re-AMI/stroke (2.9% vs 4.7%) was identified in comparison to controls. No change in ΔEF (mean difference: 0.96%, 95%CI: −0.2;2.1), ΔEDV, or ΔESV was observed compared to controls. These results were not influenced by anterior AMI location, reduced baseline EF, or the use of MRI for assessing left ventricular parameters. This meta-analysis of IPD from randomized trials in patients with recent AMI revealed that intracoronary cell therapy provided no benefit, in terms of clinical events or changes in left ventricular function.