Intracoronary Injection of Bone Marrow Derived Mononuclear Cells, Early or Late after Acute Myocardial Infarction: Effects on Global Left Ventricular Function Four months results of the SWISS-AMI trial
Background—Intracoronary administration of autologous bone marrow derived mononuclear cells (BM-MNC) may improve remodeling of the left ventricle (LV) after acute myocardial infarction (AMI). The optimal time point of administration of BM-MNC is still uncertain and has rarely been addressed prospectively in randomized clinical trials.
Methods and Results—In a multi-centre study, we randomized 200 patients with large, successfully reperfused ST segment elevation myocardial infarction (STEMI) in a 1:1:1 pattern into an open-labeled control and two BM-MNC treatment groups. In the BM-MNC groups cells were either administered "early", i.e. 5-7 days, or "late", i.e. 3-4 weeks after AMI. Cardiac magnetic resonance imaging was performed at baseline and after 4 months. The primary endpoint was the change from baseline to 4 months in global LV ejection fraction (LVEF) between the two treatment groups and the control group. The absolute change in LVEF from baseline to 4 months was -0.4±8.8% (mean±SD; p= 0.74 vs. baseline) in the control group, 1.8±8.4% (p = 0.12 vs. baseline) in the early group and 0.8±7.6% (p = 0.45 vs. baseline) in the late group. The treatment effect of BM-MNC as estimated by ANCOVA was 1.25 (95% CI -1.83 to 4.32; p = 0.42) for the early and 0.55 (95% CI -2.61 to 3.71; p = 0.73) for the late therapy group.
Conclusions—Among patients with STEMI and LV dysfunction following successful reperfusion, intracoronary infusion of BM-MNC either at 5-7 days or 3-4 weeks after AMI, did not improve LV-function at 4 months follow-up.
Clinical Trial Registration Information—http://www.clinicaltrials.gov; Identifier: NCT00355186.
- Received January 1, 2013.
- Revision received March 19, 2013.
- Accepted March 22, 2013.