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Randomized Controlled Trial
. 2020 Oct 7;41(38):3702-3710.
doi: 10.1093/eurheartj/ehaa651.

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

Anthony Mathur  1 , Francisco Fernández-Avilés  2 , Jozef Bartunek  3 , Ann Belmans  4 , Filippo Crea  5   6 , Sheik Dowlut  1 , Manuel Galiñanes  7 , Marie-Claire Good  8 , Juha Hartikainen  9 , Christine Hauskeller  10 , Stefan Janssens  11 , Petr Kala  12 , Jens Kastrup  13 , John Martin  14 , Philippe Menasché  15 , Ricardo Sanz-Ruiz  2 , Seppo Ylä-Herttuala  16 , Andreas Zeiher  17 ; BAMI Group
Affiliations
Randomized Controlled Trial

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

Anthony Mathur et al. Eur Heart J. .

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.

Keywords: Bone marrow cells; Cell- and tissue-based therapy; ST-elevation myocardial infarction.

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Figures

Graphical Abstract
Graphical Abstract
Figure 1
Figure 1
CONSORT diagram for patient flow in the BAMI trial.
Figure 2
Figure 2
Kaplan–Meier curves showing primary and secondary endpoint results in the BAMI trial: (A) Primary endpoint—all-cause mortality up to 2 years (full analysis set). (B) Secondary endpoint—cumulative incidence functions for cardiac death up to 2 years (full analysis set). (C) Secondary endpoint—cumulative incidence functions for cardiovascular death or re-hospitalization due to heart failure up to 2 years (full analysis set). (D) Secondary endpoint—cumulative incidence functions for re-hospitalization due to repeat myocardial infarction, revascularization, heart failure, implantable cardioverter-defibrillator, or stroke up to 2 years (full analysis set).
Figure 3
Figure 3
Kaplan–Meier curves showing safety and efficacy endpoints in the BAMI trial. (A) Cumulative incidence functions for any adverse event up to 6 months (safety set). (B) Cumulative incidence functions for serious adverse events up to 5 years (trial end) (safety set). (C) Cumulative incidence functions for re-hospitalization due to stroke up to 5 years (trial end) (safety set). (D) Cumulative incidence functions for bleeding up to 5 years (trial end) (safety set).
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References

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