Autologous Bone Marrow Cell Therapy in Acute Myocardial Infarction Trial - BAMI

Aug 30, 2020
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
European Commission under the 7th Framework Programme
Date Presented:
08/30/2020
Date Published:
08/29/2020
Original Posted Date:
08/30/2020
References

Contribution To Literature:

The BAMI trial failed to show that bone marrow-derived mononuclear cell intracoronary therapy was superior to standard therapy. 

Description:

The goal of the trial was to evaluate bone marrow-derived mononuclear cell intracoronary injection compared with standard therapy among patients who underwent reperfusion for acute myocardial infarction.

Study Design

  • Randomized
  • Parallel
  • Open-label

Eligible patients were randomized to bone marrow-derived mononuclear cell intracoronary infusion (n = 185) versus standard therapy (n = 190).

  • Total number of enrollees: 375
  • Duration of follow-up: 2 years
  • Mean patient age: 59 years
  • Percentage female: 19%
  • Percentage with diabetes: 16%

Inclusion criteria:

  • Acute myocardial infarction with successful reperfusion
  • Left ventricular ejection fraction (LVEF) ≤45%

Other salient features/characteristics:

  • Culprit vessel was left anterior descending in 86%
  • Core lab LVEF 39%

Principal Findings:

The primary outcome, all-cause death at 2 years, occurred in 3.3% of the bone-marrow-derived mononuclear cell group compared with 3.8% of the standard care group (p = 0.77).

Secondary outcomes:

  • Cardiovascular death or hospitalization due to heart failure: 4.9% with the bone-marrow-derived mononuclear cell group compared with 9.7% of the standard care group (p = nonsignificant)

Interpretation:

Among patients with ST-segment elevation myocardial infarction who underwent reperfusion, bone marrow-derived mononuclear cell coronary injection failed to improve all-cause mortality, or death/heart failure hospitalization. Similar trials on the topic have also failed to show a benefit from stem cell therapy. 

References:

Mathur A, Fernández-Avilés F, Bartunek J, et al. The effect of intracoronary infusion of bone marrow-derived mononuclear cells on all-cause mortality in acute myocardial infarction: the BAMI trial. Eur Heart J 2020;Aug 29:[Epub ahead of print].

Presented by Dr. Anthony Mathur at the European Society of Cardiology Virtual Congress, August 30, 2020.

Clinical Topics: Acute Coronary Syndromes, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Vascular Medicine, Acute Heart Failure, Interventions and ACS, Interventions and Vascular Medicine, Chronic Angina

Keywords: ESC Congress, ESC20, Acute Coronary Syndrome, Bone Marrow, Bone Marrow Cells, Heart Failure, Myocardial Infarction, ST Elevation Myocardial Infarction, Myocardial Reperfusion, Stem Cell Transplantation, Stroke Volume, Ventricular Function, Left


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