Abstract 3685: Intracoronary Infusion of Bone-Marrow-Derived Progenitor Cells is Associated with Improved Clinical Outcome in Patients with Acute Myocardial Infarction: 12 Months Follow Up of the REPAIR-AMI Trial
Background: Intracoronary administration of autologous progenitor cells may improve recovery of left ventricular function after acute myocardial infarction (AMI).
Methods: In the double-blind, placebo controlled multicenter trial, 204 patients with successfully reperfused AMI were randomized to intracoronary infusion of bone marrow - derived progenitor cells (BMC, n=101) or placebo medium (n=103) into the infarct artery. The study was unblinded after assessment of the primary endpoint at 4 months (LV function), and clinical events were assessed as a secondary endpoint.
Results: As of May 2006, 12 months follow-up has been completed in 63% of the patients (follow-up = 9.1±4.1 months). There was a total of 7 deaths (5 Placebo versus 2 BMC, p = 0.45) and 5 myocardial infarctions (MI, 5 versus 0, p = 0.06) resulting in a significant difference for the combined endpoint death/MI in favour of the BMC group (p = 0.033). Likewise, repeated revascularization was less frequent in the BMC group compared to placebo (n = 21 versus n = 35, p = 0.035). There were no differences in arrhythmogenic events (n = 5 in each group, p = 1.0). Most importantly, the combined endpoint death, MI or rehospitalization due to heart failure was significantly reduced in the BMC group (n = 2 versus n = 11, p = 0.011).
Conclusions: Although the study was not powered to detect significant differences in clinical events, cardiovascular event rates after a mean of 9 months follow-up are significantly reduced in patients receiving BMC infusion, indicating that the therapy is not only safe, but may even have the potential to reduce major adverse cardiovascular events. Final 12 months follow-up results will be presented at the meeting.