TY - JOUR
T1 - Meta-analysis of cell-based CaRdiac stUdiEs (ACCRUE) in patients with acute myocardial infarction based on individual patient data
AU - Gyöngyösi, Mariann
AU - Wojakowski, Wojciech
AU - Lemarchand, Patricia
AU - Lunde, Ketil
AU - Tendera, Michal
AU - Bartunek, Jozef
AU - Marban, Eduardo
AU - Assmus, Birgit
AU - Henry, Timothy D.
AU - Traverse, Jay H.
AU - Moyé, Lemuel A.
AU - Sürder, Daniel
AU - Corti, Roberto
AU - Huikuri, Heikki
AU - Miettinen, Johanna
AU - Wöhrle, Jochen
AU - Obradovic, Slobodan
AU - Roncalli, Jérome
AU - Malliaras, Konstantinos
AU - Pokushalov, Evgeny
AU - Romanov, Alexander
AU - Kastrup, Jens
AU - Bergmann, Martin W.
AU - Atsma, Douwe E.
AU - Diederichsen, Axel
AU - Edes, Istvan
AU - Benedek, Imre
AU - Benedek, Theodora
AU - Pejkov, Hristo
AU - Nyolczas, Noemi
AU - Pavo, Noemi
AU - Bergler-Klein, Jutta
AU - Pavo, Imre J.
AU - Sylven, Christer
AU - Berti, Sergio
AU - Navarese, Eliano P.
AU - Maurer, Gerald
PY - 2015/4/10
Y1 - 2015/4/10
N2 - Rationale: 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. Objective: 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). Methods and Results: 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. Conclusions: 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.
AB - Rationale: 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. Objective: 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). Methods and Results: 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. Conclusions: 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.
KW - anterior wall myocardial infarction
KW - heart failure
KW - meta-analysis
KW - outcome assessment
KW - stem cells
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U2 - 10.1161/CIRCRESAHA.116.304346
DO - 10.1161/CIRCRESAHA.116.304346
M3 - Article
C2 - 25700037
AN - SCOPUS:84929003354
SN - 0009-7330
VL - 116
SP - 1346
EP - 1360
JO - Circulation Research
JF - Circulation Research
IS - 8
ER -