The effect of intracoronary infusion of bone marrow-derived mononuclear cells on all-cause mortality in acute myocardial infarction : the BAMI trial
Mathur, Anthony (Centre for Cardiovascular Medicine & Devices, Queen Mary University of London)
Fernández Avilés, F. (Hospital General Universitario Gregorio Marañón)
Bartunek, Jozef (Cardiovascular Center, OLV Hospital Aalst)
Belmans, Ann (KU)
Crea, Filippo (Fondazione Policlinico Universitario A. Gemelli IRCCS)
Dowlut, Sheik (Centre for Cardiovascular Medicine & Devices, Queen Mary University of London)
Galiñanes, Manuel (Hospital Universitari Vall d'Hebron)
Good, Marie-Claire (Queen Mary University of London)
Hartikainen, Juha (Kuopio University Hospital ( Finlàndia))
Hauskeller, Christine (University of Exeter)
Janssens, Stefan (University Hospitals Leuven (Bèlgica))
Kala, Petr (University Hospital Brno (República Txeca))
Kastrup, Jens (University of Copenhagen)
Martin, John (University College London)
Menasché, Philippe (Department of Cardiovascular Surgery, Hôpital Européen Georges Pompidou and University of Paris)
Sanz-Ruiz, Ricardo (Hospital General Universitario Gregorio Marañón)
Ylä-Herttuala, Seppo (University of Eastern Finland)
Zeiher, Andreas Michael (Department of Medicine III, Goethe University of Frankfurt)
Universitat Autònoma de Barcelona

Date:	2020
Abstract:	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. 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. 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.
Grants:	European Commission 278967
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	ST-elevation myocardial infarction ; Cell- and tissue-based therapy ; Bone marrow cells
Published in:	European heart journal, Vol. 41 (august 2020) , p. 3702-3710, ISSN 1522-9645

DOI: 10.1093/eurheartj/ehaa651
PMID: 32860406

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