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.

Cardiovascular Center OLV Hospital Aalst Aalst Belgium

Catholic University of the Sacred Heart Rome Italy

Centre for Cardiovascular Medicine and Devices Queen Mary University of London London EC1M 6BQ UK

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

Department of Cardiovascular Surgery Hôpital Européen Georges Pompidou and University of Paris Paris France

Department of Medicine 3 Goethe University of Frankfurt Frankfurt Germany

Fondazione Policlinico Universitario A Gemelli IRCCS Rome Italy

Hospital General Universitario Gregorio Marañón Instituto de Investigación Sanitaria del Hospital Gregorio Marañón CIBERCV Madrid Spain

KU Leuven Leuven Belgium

Kuopio University Hospital Kuopio Finland

Queen Mary University of London London UK

Rigshospitalet and University of Copenhagen Denmark

University College London London UK

University Hospital Brno and Medical Faculty of Masaryk University Brno Czech Republic

University Hospitals Leuven Belgium

University of Eastern Finland Finland

University of Exeter Exeter UK

Eur Heart J. 2020 Oct 7;41(38):3711-3714. doi: 10.1093/eurheartj/ehaa802. PubMed

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