Detail
Article
Online article
FT
Medvik - BMC
  • Something wrong with this record ?

The effect of intracoronary infusion of bone marrow-derived mononuclear cells on all-cause mortality in acute myocardial infarction: the BAMI trial

A. Mathur, F. Fernández-Avilés, J. Bartunek, A. Belmans, F. Crea, S. Dowlut, M. Galiñanes, MC. Good, J. Hartikainen, C. Hauskeller, S. Janssens, P. Kala, J. Kastrup, J. Martin, P. Menasché, R. Sanz-Ruiz, S. Ylä-Herttuala, A. Zeiher, BAMI Group

. 2020 ; 41 (38) : 3702-3710. [pub] 20201007

Language English Country Great Britain

Document type Journal Article, Observational Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't

Persistent link   https://www.medvik.cz/link/bmc21019998

AIMS: Bone marrow-derived mononuclear cell (BM-MNC) therapy may improve myocardial recovery in patients following acute myocardial infarction (AMI), though existing trial results are inconsistent. METHODS AND RESULTS: Originally an open-label, multicentre Phase III trial, BAMI was designed to demonstrate the safety and efficacy of intracoronary infusion of BM-MNCs in reducing the time to all-cause mortality in patients with reduced left ventricular ejection fraction (LVEF, ≤45%) after primary angioplasty (PPCI) for ST-elevation AMI. Unexpectedly low recruitment means the trial no longer qualifies as a hypothesis-testing trial, but is instead an observational study with no definitive conclusions possible from statistical analysis. In total, 375 patients were recruited: 185 patients were randomized to the treatment arm (intracoronary infusion of BM-MNCs 2-8 days after PPCI) and 190 patients to the control arm (optimal medical therapy). All-cause mortality at 2 years was 3.26% [6 deaths; 95% confidence interval (CI): 1.48-7.12%] in the BM-MNC group and 3.82% (7 deaths; 95% CI: 1.84-7.84%) in the control group. Five patients (2.7%, 95% CI: 1.0-5.9%) in the BM-MNC group and 15 patients (8.1%, CI : 4.7-12.5%) in the control group were hospitalized for heart failure during 2 years of follow-up. Neither adverse events nor serious adverse events differed between the two groups. There were no patients hospitalized for stroke in the control group and 4 (2.2%) patients hospitalized for stroke in the BM-MNC group. CONCLUSIONS: Although BAMI is the largest trial of autologous cell-based therapy in the treatment of AMI, unexpectedly low recruitment and event rates preclude any meaningful group comparisons and interpretation of the observed results.

References provided by Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc21019998
003      
CZ-PrNML
005      
20210830101609.0
007      
ta
008      
210728s2020 xxk f 000 0|eng||
009      
AR
024    7_
$a 10.1093/eurheartj/ehaa651 $2 doi
035    __
$a (PubMed)32860406
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxk
100    1_
$a Mathur, Anthony $u Centre for Cardiovascular Medicine & Devices, Queen Mary University of London, London EC1M 6BQ, UK
245    14
$a The effect of intracoronary infusion of bone marrow-derived mononuclear cells on all-cause mortality in acute myocardial infarction: the BAMI trial / $c A. Mathur, F. Fernández-Avilés, J. Bartunek, A. Belmans, F. Crea, S. Dowlut, M. Galiñanes, MC. Good, J. Hartikainen, C. Hauskeller, S. Janssens, P. Kala, J. Kastrup, J. Martin, P. Menasché, R. Sanz-Ruiz, S. Ylä-Herttuala, A. Zeiher, BAMI Group
520    9_
$a AIMS: Bone marrow-derived mononuclear cell (BM-MNC) therapy may improve myocardial recovery in patients following acute myocardial infarction (AMI), though existing trial results are inconsistent. METHODS AND RESULTS: Originally an open-label, multicentre Phase III trial, BAMI was designed to demonstrate the safety and efficacy of intracoronary infusion of BM-MNCs in reducing the time to all-cause mortality in patients with reduced left ventricular ejection fraction (LVEF, ≤45%) after primary angioplasty (PPCI) for ST-elevation AMI. Unexpectedly low recruitment means the trial no longer qualifies as a hypothesis-testing trial, but is instead an observational study with no definitive conclusions possible from statistical analysis. In total, 375 patients were recruited: 185 patients were randomized to the treatment arm (intracoronary infusion of BM-MNCs 2-8 days after PPCI) and 190 patients to the control arm (optimal medical therapy). All-cause mortality at 2 years was 3.26% [6 deaths; 95% confidence interval (CI): 1.48-7.12%] in the BM-MNC group and 3.82% (7 deaths; 95% CI: 1.84-7.84%) in the control group. Five patients (2.7%, 95% CI: 1.0-5.9%) in the BM-MNC group and 15 patients (8.1%, CI : 4.7-12.5%) in the control group were hospitalized for heart failure during 2 years of follow-up. Neither adverse events nor serious adverse events differed between the two groups. There were no patients hospitalized for stroke in the control group and 4 (2.2%) patients hospitalized for stroke in the BM-MNC group. CONCLUSIONS: Although BAMI is the largest trial of autologous cell-based therapy in the treatment of AMI, unexpectedly low recruitment and event rates preclude any meaningful group comparisons and interpretation of the observed results.
650    _2
$a kostní dřeň $7 D001853
650    _2
$a transplantace kostní dřeně $7 D016026
650    _2
$a lidé $7 D006801
650    12
$a infarkt myokardu $x terapie $7 D009203
650    _2
$a tepový objem $7 D013318
650    _2
$a autologní transplantace $7 D014182
650    _2
$a výsledek terapie $7 D016896
650    12
$a funkce levé komory srdeční $7 D016277
655    _2
$a časopisecké články $7 D016428
655    _2
$a pozorovací studie $7 D064888
655    _2
$a randomizované kontrolované studie $7 D016449
655    _2
$a práce podpořená grantem $7 D013485
700    1_
$a Fernández-Avilés, Francisco $u Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria del Hospital Gregorio Marañón, CIBERCV, Madrid, Spain
700    1_
$a Bartunek, Jozef $u Cardiovascular Center, OLV Hospital Aalst, Aalst, Belgium
700    1_
$a Belmans, Ann $u KU, Leuven, Leuven, Belgium
700    1_
$a Crea, Filippo $u Catholic University of the Sacred Heart, Rome, Italy $u Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
700    1_
$a Dowlut, Sheik $u Centre for Cardiovascular Medicine & Devices, Queen Mary University of London, London EC1M 6BQ, UK
700    1_
$a Galiñanes, Manuel $u Department of Cardiac Surgery, Reparative Therapy of the Heart, Vall d'Hebron Research Institute, University Hospital Vall d'Hebron, Autonomous University of Barcelona, Barcelona, Spain
700    1_
$a Good, Marie-Claire $u Queen Mary University of London, London, UK
700    1_
$a Hartikainen, Juha $u Kuopio University Hospital, Kuopio, Finland
700    1_
$a Hauskeller, Christine $u University of Exeter, Exeter, UK
700    1_
$a Janssens, Stefan $u University Hospitals (UZ) Leuven, Belgium
700    1_
$a Kala, Petr $u University Hospital Brno and Medical Faculty of Masaryk University, Brno, Czech Republic
700    1_
$a Kastrup, Jens $u Rigshospitalet and University of Copenhagen, Denmark
700    1_
$a Martin, John $u University College London, London, UK
700    1_
$a Menasché, Philippe $u Department of Cardiovascular Surgery, Hôpital Européen Georges Pompidou and University of Paris, Paris, France
700    1_
$a Sanz-Ruiz, Ricardo $u Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria del Hospital Gregorio Marañón, CIBERCV, Madrid, Spain
700    1_
$a Ylä-Herttuala, Seppo $u University of Eastern Finland, Finland
700    1_
$a Zeiher, Andreas $u Department of Medicine III, Goethe University of Frankfurt, Frankfurt, Germany
710    2_
$a BAMI Group
773    0_
$w MED00009622 $t European heart journal $x 1522-9645 $g Roč. 41, č. 38 (2020), s. 3702-3710
856    41
$u https://pubmed.ncbi.nlm.nih.gov/32860406 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y p $z 0
990    __
$a 20210728 $b ABA008
991    __
$a 20210830101609 $b ABA008
999    __
$a ok $b bmc $g 1690732 $s 1140444
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2020 $b 41 $c 38 $d 3702-3710 $e 20201007 $i 1522-9645 $m European heart journal $n Eur Heart J $x MED00009622
LZP    __
$a Pubmed-20210728

Find record

Citation metrics

Archiving options