Meta-Analysis of Cell-based CaRdiac stUdiEs (ACCRUE) in patients with acute myocardial infarction based on individual patient data.

Mariann Gyöngyösi 1, * Wojciech Wojakowski 2 Patricia Lemarchand 3 Ketil Lunde 4 Michal Tendera 2 Jozef Bartunek 5 Eduardo Marban 6 Birgit Assmus 7 Timothy Henry 8 Jay Traverse 9 Lemuel Moyé 10 Daniel Sürder 11 Roberto Corti 12 Heikki Huikuri 13 Johanna Miettinen 13 Jochen Wöhrle 14 Slobodan Obradovic 15 Jérome Roncalli 16 Konstantinos Malliaras 6 Evgeny Pokushalov 17 Alexander Romanov 17 Jens Kastrup 18 Martin Bergmann 19 Douwe Atsma 20 Axel Diederichsen 21 Istvan Edes 22 Imre Benedek 23 Theodora Benedek 23 Hristo Pejkov 24 Noemi Nyolczas 25 Noemi Pavo 1 Jutta Bergler-Klein 1 Imre Pavo 1 Christer Sylven 26 Sergio Berti 27 Eliano Navarese 28 Gerald Maurer 1
Abstract : The meta-Analysis of Cell-based CaRdiac study is the first prospectively declared collaborative multinational database, including individual data of patients with ischemic heart disease treated with cell therapy. We analyzed the safety and efficacy of intracoronary cell therapy after acute myocardial infarction (AMI), including individual patient data from 12 randomized trials (ASTAMI, Aalst, BOOST, BONAMI, CADUCEUS, FINCELL, REGENT, REPAIR-AMI, SCAMI, SWISS-AMI, TIME, LATE-TIME; n=1252). The primary end point was freedom from combined major adverse cardiac and cerebrovascular events (including all-cause death, AMI recurrance, stroke, and target vessel revascularization). The secondary end point was freedom from hard clinical end points (death, AMI recurrence, or stroke), assessed with random-effects meta-analyses and Cox regressions for interactions. Secondary efficacy end points included changes in end-diastolic volume, end-systolic volume, and ejection fraction, analyzed with random-effects meta-analyses and ANCOVA. We reported weighted mean differences between cell therapy and control groups. No effect of cell therapy on major adverse cardiac and cerebrovascular events (14.0% versus 16.3%; hazard ratio, 0.86; 95% confidence interval, 0.63-1.18) or death (1.4% versus 2.1%) or death/AMI recurrence/stroke (2.9% versus 4.7%) was identified in comparison with controls. No changes in ejection fraction (mean difference: 0.96%; 95% confidence interval, -0.2 to 2.1), end-diastolic volume, or systolic volume were observed compared with controls. These results were not influenced by anterior AMI location, reduced baseline ejection fraction, or the use of MRI for assessing left ventricular parameters. This meta-analysis of individual patient data 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. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01098591.
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Circulation Research, American Heart Association, 2015, 116 (8), pp.1346-60. 〈10.1161/CIRCRESAHA.116.304346〉
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Mariann Gyöngyösi, Wojciech Wojakowski, Patricia Lemarchand, Ketil Lunde, Michal Tendera, et al.. Meta-Analysis of Cell-based CaRdiac stUdiEs (ACCRUE) in patients with acute myocardial infarction based on individual patient data.. Circulation Research, American Heart Association, 2015, 116 (8), pp.1346-60. 〈10.1161/CIRCRESAHA.116.304346〉. 〈inserm-01261631v2〉

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