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.

Mathur, A., Fernandez-Aviles, F., Bartunek, J., Belmans, A., Crea, F., Dowlut, S., Galinanes, M., Good, M. -., Hartikainen, J., Hauskeller, C., Janssens, S., Kala, P., Kastrup, J., Martin, J., Menasche, P., Sanz-Ruiz, R., Yla-Herttuala, S., Zeiher, A., The effect of intracoronary infusion of bone marrow-derivedmononuclear cells on all-cause mortality in acutemyocardial infarction: The BAMI trial, <<EUROPEAN HEART JOURNAL>>, 2020; 41 (38): 3702-3710. [doi:10.1093/eurheartj/ehaa651] [http://hdl.handle.net/10807/166479]

The effect of intracoronary infusion of bone marrow-derivedmononuclear cells on all-cause mortality in acutemyocardial infarction: The BAMI trial

Crea, Filippo;
2020

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.
2020
Inglese
Mathur, A., Fernandez-Aviles, F., Bartunek, J., Belmans, A., Crea, F., Dowlut, S., Galinanes, M., Good, M. -., Hartikainen, J., Hauskeller, C., Janssens, S., Kala, P., Kastrup, J., Martin, J., Menasche, P., Sanz-Ruiz, R., Yla-Herttuala, S., Zeiher, A., The effect of intracoronary infusion of bone marrow-derivedmononuclear cells on all-cause mortality in acutemyocardial infarction: The BAMI trial, <<EUROPEAN HEART JOURNAL>>, 2020; 41 (38): 3702-3710. [doi:10.1093/eurheartj/ehaa651] [http://hdl.handle.net/10807/166479]
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