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REGENERATE-AMI: Bone marrow-derived cells reduces infarct size, improves myocardial salvage in acute MI
Intracoronary injection of bone marrow-derived cells within 24 hours of primary PCI reduced infarct size and increased myocardial salvage in patients with acute MI, according to recent findings.
The therapy also resulted in a nonsignificant improvement to left ventricular function at 1 year compared with placebo, the researchers wrote.
In the multicenter, phase 2, double blind trial, researchers aimed to determine the effect of autologous bone marrow-derived cells delivered within 24 hours of successful reperfusion therapy on left ventricular function. The study included 100 patients with anterior acute MI and significant regional wall motion abnormality (mean age, 56.5 years; 87% men). Forty-five patients were randomly assigned placebo and 55 were assigned bone marrow-derived cells 24 hours after primary PCI.
Change in left ventricular ejection fraction at 1 year from baseline as indicated by advanced cardiac imaging was the primary endpoint, with evaluable 1-year data for 92 patients.
Results indicated increases in LVEF between baseline and 1 year in both study arms. In the treatment group, the increase was 5.1%, from 47.5 ± 9.2% to 52.6 ± 10.5% (P < .0001). For patients treated with placebo, the increase was 2.8%, from 49.2 ± 9.6% to 52 ± 9.1% (P = .0019). A post hoc analysis determined that the absolute increase for the bone marrow-derived cell group was 2.2% (95% CI, –0.5 to 5), which was not statistically significant (P = .1).
At 3 days, patients in the treated group had a smaller infarct size than those who received placebo (-5.4%; 95% CI, -9.4 to -1.4; P = .0084). However, reduction in infarct size was greater in the placebo group than the treated group over time (4.1%; 95% CI, 0.3-7.9; P = .033). Patients in the treated group experienced a significant improvement in myocardial salvage index compared with those receiving placebo (0.1%; 95% CI, 0-0.2).
LV end systolic volume, LV end diastolic volume and cardiac output were similar between and within the study arms at 3 months and 1 year. NYHA classification also was similar between the two study arms.
Major adverse event rates were low in both groups, the researchers wrote. No deaths occurred among those who received placebo, while one patient in the treated group died due to MI at 6 months.
“REGENERATE-AMI demonstrates the safety and feasibility of early intracoronary injection of [bone marrow-derived cells] which supports the delivery of cell therapy within the timeframe of standard [acute] MI hospitalization,” the researchers concluded. – by Rob Volansky
Disclosure: The researchers report no relevant financial disclosures.