Abstract 13940: Intracoronary Infusion of Bone Marrow-Derived Mononuclear Cells in Acute Myocardial Infarction: 5 Year Clinical Outcome and MRI Data of the Randomized, Double-Blind, Placebo-Controlled REPAIR-AMI Trial
Background: Several randomized clinical trials investigated the efficacy of intracoronary bone marrow-derived mononuclear cells (BMC) administration in acute myocardial infraction (AMI). The so far largest double-blind, Placebo-controlled multicenter REPAIR-AMI trial has demonstrated that intracoronary infusion of BMC is associated with significantly enhanced contractile recovery at 4 months (short-term follow-up) following acute myocardial infarction. The present analysis investigated the long-term safety, clinical outcome, predictors of outcome, and functional LV parameters derived from MRI at 5 years.
Methods: REPAIR-AMI randomly assigned 204 patients to receive intracoronary infusion of BMC or placebo medium 3 to 7 days after successful AMI reperfusion therapy. 5-year follow-up is available for 98% of patients. In a subgroup of 62 patients serial cardiac MRIs were performed at baseline, after 4 months (short-term effect) and at the 5 year follow-up.
Results: Within 5 year follow-up period, 15 patients of the placebo group died compared to 7 patients in the BMC- group (p=0.07). No heart failure-related death occurred in the BMC group. No significant difference was observed for sudden cardiac death (n=3, in each group), ventricular arrhythmia or syncope (7 vs. 6, p=0.79) and development of cancer (7 vs. 4; p=0.4). The prespecified combined endpoint of death, recurrent AMI and necessity for revascularization was significantly less frequent in the BMC-group (20 vs. 11 events, p=0.03). By multivariate regression analysis recovery of LV-EF and Cadillac risk score were the only independent predictors (p<0.001) for overall mortality at five-year follow up. MRI-based analysis of LV-function at 5 year follow-up documented sustained improvement (p=0.006) of LV-EF in the BMC group (LV-EF+5.9%), but a slight decrease of LV-EF in the placebo group (LV-EF-2.1 %). LV endsystolic volume was significantly reduced in the BMC group, but remained unchanged in the placebo group.
Conclusions: Intracoronary administration of BMC is safe and associated with better clinical outcome 5 years after myocardial infarction. BMC treatment is associated with a improved global LV-function and ameliorates adverse LV remodelling during long-term follow up.
- © 2011 by American Heart Association, Inc.