Abstract 2669: Autologous Bone Marrow Mononucleated Cell Infusion for Acute Myocardial Infarction in Patients with Severe Left Ventricular Dysfunction: Results of the BONAMI Trial (A Mutlicenter Randomized Controlled Trial)
Background Previous trials that assessed the efficacy of intracoronary administration of autologous bone marrow cells (BMCs) suggest that BMC-based therapy is more effective in patients with decreased left ventricular ejection fraction (LVEF), receiving cell therapy at least 5 days after MI. We designed a randomized, multicenter controlled trial to specifically assess the advantage of cell therapy in such patients.
Methods Patients with acute MI, LVEF < 45% and regional impairment of myocardial viability were enrolled in 6 academic hospitals. After coronary reperfusion, 101 patients with optimal medical treatment were randomised to a control group (n=49) or a BMC group (n=52) that received an intracoronary infusion of 100.106 autologous BMCs. Primary endpoint was the improvement of myocardial viability (perfusion score on the 17 LV segments) 3 months after MI assessed by resting Tl201-SPECT. LVEF was assessed at baseline and at 3 months by radionucleide angiography (RNA) and echocardiography. MI scar size was measured by MRI. All measurements were performed by independent imaging core labs.
Results Mean (± SD) LVEF measured by RNA at baseline was 36.3 ±6.9%, with no difference between groups. Mean delay between acute MI and BMC infusion was 9.3 ±1.7 days. Data from 47/52 BMC and 43/49 control patients were analyzed at 3 months. Myocardial perfusion score improved in 16/47 (34%) patients in the BMC group as compared to 7/43 (16%) patients in the control group (p = 0.06). No difference was observed for LVEF between BMC and control group as assessed by RNA (38.9 ± 10.3% vs. 41.3 ± 9.0%, p = 0.6) and by echocardiography (39.1 ± 10.2% vs. 41.5 ± 8.8%, p = 0.7). No difference was observed for scar size with MRI (30.9 ± 13.9% vs. 27.7 ± 9.5%, p = 0.6). No specific major cardiovascular adverse events were related to the cell therapy procedure.
Conclusion Intracoronary autologous BMCs administration to patients with decreased LVEF 9 days after an acute MI was associated with a tendency to improve myocardial viability 3 months after MI. A large multicentre international trial is warranted to further document the efficacy of cardiac cell therapy with standardized protocol for cell preparation as well as for assessment of cardiac function. (ClinicalTrials. gov number NCT00200707).