Abstract 3439: Sustained 2 Year Clinical Benefit From Intracoronary Infusion of Bone Marrow-derived Progenitor Cells in Patients After Acute Myocardial Infarction
Background: Intracoronary administration of autologous, bone marrow-derived progenitor cells (BMC) beneficially effects left ventricular function and cardiovascular event rate within the first months after acute myocardial infarction (AMI), but there is uncertainty about the durability of the effects and the significance for preventing heart failure.
Methods: In the double-blind, placebo controlled multicenter trial (REPAIR-AMI) 204 patients with successfully reperfused AMI were randomized to 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); however clinical events were subsequently centrally assessed in a blinded fashion.
Results: As of today, 2 years follow-up has been completed in 52% of the patients. There were a total of 10 deaths (8 Placebo versus 2 BMC, p=0.10) and 7 myocardial infarctions (MI, 7 versus 0, p=0.01) resulting in a significant difference for the combined endpoint death/MI in favour of the BMC group (p=0.006). There were no differences in arrhythmogenic events (n=6 in each group, p=0.97). Most importantly, the combined endpoint death, MI or rehospitalization for heart failure was significantly reduced in the BMC group (n=15 versus n =2, figure⇓).
Conclusions: During preliminary 2 year follow-up, cardiovascular events - associated with progression towards heart failure - are progressively reduced in patients receiving intracoronary infusion of bone marrow-derived progenitor cells, indicating sustained clinical benefit. Thus, further trials with clinical endpoints are warranted. Final 2 years follow-up results will be presented.