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

Abstract

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.

• Authors: Anthony Mathur, Francisco Fernández-Avilés, Jozef Bartunek, Ann Belmans, Filippo Crea, Sheik Dowlut, Manuel Galiñanes, Marie-Claire Good, Juha Hartikainen, Christine Hauskeller, Stefan Janssens, Petr Kala, Jens Kastrup, John Martin, Philippe Menasché, Ricardo Sanz-Ruiz, Seppo Ylä-Herttuala, Andreas Zeiher, BAMI Group
• Journal: European heart journal (Eur Heart J) Vol. 41 Issue 38 Pg. 3702-3710 (10 07 2020) ISSN: 1522-9645 [Electronic] England
• PMID: 32860406 (Publication Type: Journal Article, Observational Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Cardiology.

Topics

• Bone Marrow
• Bone Marrow Transplantation
• Humans
• Myocardial Infarction (therapy)
• Stroke Volume
• Transplantation, Autologous
• Treatment Outcome
• Ventricular Function, Left