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

Mariann Gyöngyösi; Wojciech Wojakowski; Patricia Lemarchand; Ketil Lunde; Michal Tendera; Jozef Bartunek; Eduardo Marban; Birgit Assmus; Timothy D Henry; Jay H Traverse; Lemuel A Moyé; Daniel Sürder; Roberto Corti; Heikki Huikuri; Johanna Miettinen; Jochen Wöhrle; Slobodan Obradovic; Jérome Roncalli; Konstantinos Malliaras; Evgeny Pokushalov; Alexander Romanov; Jens Kastrup; Martin W Bergmann; Douwe E Atsma; Axel Diederichsen; Istvan Edes; Imre Benedek; Theodora Benedek; Hristo Pejkov; Noemi Nyolczas; Noemi Pavo; Jutta Bergler-Klein; Imre J Pavo; Christer Sylven; Sergio Berti; Eliano P Navarese; Gerald Maurer; ACCRUE Investigators

doi:10.1161/CIRCRESAHA.116.304346

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

Mariann Gyöngyösi, Wojciech Wojakowski, Patricia Lemarchand, Ketil Lunde, Michal Tendera, Jozef Bartunek, Eduardo Marban, Birgit Assmus, Timothy D Henry, Jay H Traverse, Lemuel A Moyé, Daniel Sürder, Roberto Corti, Heikki Huikuri, Johanna Miettinen, Jochen Wöhrle, Slobodan Obradovic, Jérome Roncalli, Konstantinos Malliaras, Evgeny PokushalovAlexander Romanov, Jens Kastrup, Martin W Bergmann, Douwe E Atsma, Axel Diederichsen, Istvan Edes, Imre Benedek, Theodora Benedek, Hristo Pejkov, Noemi Nyolczas, Noemi Pavo, Jutta Bergler-Klein, Imre J Pavo, Christer Sylven, Sergio Berti, Eliano P Navarese, Gerald Maurer, ACCRUE Investigators

268 Citationer (Scopus)

Abstract

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.

CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01098591.

Originalsprog	Engelsk
Tidsskrift	Circulation Research
Vol/bind	116
Udgave nummer	8
Sider (fra-til)	1346-60
Antal sider	15
ISSN	0009-7330
DOI	https://doi.org/10.1161/CIRCRESAHA.116.304346
Status	Udgivet - 10 apr. 2015

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10.1161/CIRCRESAHA.116.304346

Citationsformater

Gyöngyösi, M., Wojakowski, W., Lemarchand, P., Lunde, K., Tendera, M., Bartunek, J., Marban, E., Assmus, B., Henry, T. D., Traverse, J. H., Moyé, L. A., Sürder, D., Corti, R., Huikuri, H., Miettinen, J., Wöhrle, J., Obradovic, S., Roncalli, J., Malliaras, K., ... ACCRUE Investigators (2015). Meta-Analysis of Cell-based CaRdiac stUdiEs (ACCRUE) in patients with acute myocardial infarction based on individual patient data. Circulation Research, 116(8), 1346-60. https://doi.org/10.1161/CIRCRESAHA.116.304346

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 2015, 'Meta-Analysis of Cell-based CaRdiac stUdiEs (ACCRUE) in patients with acute myocardial infarction based on individual patient data', Circulation Research, bind 116, nr. 8, s. 1346-60. https://doi.org/10.1161/CIRCRESAHA.116.304346

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

abstract = "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.CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01098591.",

keywords = "Aged, Bone Marrow Transplantation, Cerebrovascular Disorders, Chi-Square Distribution, Databases, Factual, Disease-Free Survival, Female, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Myocardial Contraction, Myocardial Infarction, Myocardium, Proportional Hazards Models, Prospective Studies, Randomized Controlled Trials as Topic, Recovery of Function, Recurrence, Regeneration, Risk Factors, Stroke Volume, Time Factors, Treatment Outcome, Ventricular Function, Left, Ventricular Remodeling",

author = "Mariann Gy{\"o}ngy{\"o}si and Wojciech Wojakowski and Patricia Lemarchand and Ketil Lunde and Michal Tendera and Jozef Bartunek and Eduardo Marban and Birgit Assmus and Henry, {Timothy D} and Traverse, {Jay H} and Moy{\'e}, {Lemuel A} and Daniel S{\"u}rder and Roberto Corti and Heikki Huikuri and Johanna Miettinen and Jochen W{\"o}hrle and Slobodan Obradovic and J{\'e}rome Roncalli and Konstantinos Malliaras and Evgeny Pokushalov and Alexander Romanov and Jens Kastrup and Bergmann, {Martin W} and Atsma, {Douwe E} and Axel Diederichsen and Istvan Edes and Imre Benedek and Theodora Benedek and Hristo Pejkov and Noemi Nyolczas and Noemi Pavo and Jutta Bergler-Klein and Pavo, {Imre J} and Christer Sylven and Sergio Berti and Navarese, {Eliano P} and Gerald Maurer and {ACCRUE Investigators}",

note = "{\textcopyright} 2015 American Heart Association, Inc.",

year = "2015",

month = apr,

day = "10",

doi = "10.1161/CIRCRESAHA.116.304346",

language = "English",

volume = "116",

pages = "1346--60",

journal = "Circulation Research",

issn = "0009-7330",

publisher = "Lippincott Williams and Wilkins",

number = "8",

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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

AU - ACCRUE Investigators

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.CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01098591.

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.CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01098591.

KW - Aged

KW - Bone Marrow Transplantation

KW - Cerebrovascular Disorders

KW - Chi-Square Distribution

KW - Databases, Factual

KW - Disease-Free Survival

KW - Female

KW - Humans

KW - Kaplan-Meier Estimate

KW - Male

KW - Middle Aged

KW - Myocardial Contraction

KW - Myocardial Infarction

KW - Myocardium

KW - Proportional Hazards Models

KW - Prospective Studies

KW - Randomized Controlled Trials as Topic

KW - Recovery of Function

KW - Recurrence

KW - Regeneration

KW - Risk Factors

KW - Stroke Volume

KW - Time Factors

KW - Treatment Outcome

KW - Ventricular Function, Left

KW - Ventricular Remodeling

U2 - 10.1161/CIRCRESAHA.116.304346

DO - 10.1161/CIRCRESAHA.116.304346

M3 - Journal article

C2 - 25700037

SN - 0009-7330

VL - 116

SP - 1346

EP - 1360

JO - Circulation Research

JF - Circulation Research

IS - 8

ER -

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

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