Abstract 15289: Stem Cell Therapy in ST-Elevation Myocardial Infarction With Reduced Ejection Fraction: A Multicenter, Randomized, Double-Blind Trial. From MiHeart/AMI Investigators
Introduction: Left ventricular ejection fraction (LVEF) is a major determinant of long-term prognosis after ST-elevation myocardial infarction (STEMI). STEMI patients with reduced LVEF have poor outcome, with a high incidence of sudden death and death due to heart failure , despite utilization of renin-angiotensin-aldosterone system inhibitors and betablockers. Therefore, new strategies that could improve outcomes of this high-risk population are necessary, and testing one of these strategies was the main goal of the present study.
Hypothesis: We conducted a double blind, randomized, multicenter study to test if intracoronary infusion of bone marrow derived mononuclear-cells (BMMC) could improve LVEF in patients with STEMI.
Methods: Eligible patients with STEMI were enrolled if fulfilled the following inclusion criteria: age between 30 and 80 years; LVEF < 50% (by Simpson method at echocardiogram), successful angioplasty of infarct related artery (IRA) and regional dysfunction in the infarct-related area, analyzed before cell injection. BMMC were obtained from bone marrow aspirate performed between 5 and 7 days after MI. An opaque syringe was used to store infusion solution (placebo or cells) to avoid unblinding, and content was infused into IRA during a second angiogram using an over-the-wire balloon. Two cardiac magnetic resonance images (MRI) were used to asses LVEF, left ventricle volumes and infarct size, in the first 7-9 days post-MI, and the second at 6 months post-MI.
Results: A total of one hundred and twenty-seven patients were included in the final analysis. No serious adverse event was related to infusion procedure. Results concerning LVEF, left ventricle volumes and infarct size are described in the following Table.
Conclusions: In this randomized, multicenter, double-blind trial, BMMC intracoronary infusion did not improve left ventricle systolic function, infarct size or cardiac chamber volumes. Infusion procedure was overall safe.
Author Disclosures: J.C. Nicolau: None. R.H. Furtado: None. C.E. Rochitte: None. I.T. Schettert: None. H.F. Dohmann: None. S.A. Silva: None. A.C. Carvalho: None.
- © 2016 by American Heart Association, Inc.