Abstract
ObjectiveThe long-term (5-year) outcome of early (3–6 weeks after acute myocardial infarction [AMI], BM-MNC Early group) and late (3–4 months after AMI, BM-MNC Late group) combined (percutaneous intramyocardial and intracoronary) delivery of autologous bone marrow mononuclear cells (BM-MNCs) was evaluated in patients with ejection fractions (EF) between 30–45% post-AMI.MethodsMajor adverse cardiac and cerebrovascular events (MACCE) and hospitalization were recorded. Left (LV) and right (RV) ventricular function were measured by transthoracic echocardiography. Cardiac magnetic resonance imaging (MRI) and myocardial single photon emission computed tomography was performed in a subgroup of patients. Pre-cell therapy myocardial voltage values of treated areas (assessed by NOGA mapping) were correlated with clinical outcome.ResultsFive-year MACCE incidences (7.4%. vs 24.1%) and the composite of all adverse events (11.1% vs 27.6%) were not different between the Early and Late treatment groups. The significant LV-EF increase at 1-year follow-up was preserved at the 5-year control (from baseline to 5-year: 5.3%, 95% CI:0.5–10.1, and 5.7%, 95% CI:1.7–9.6, p<0.05 in the Early and Late groups, respectively), with no significant changes between 1- and 5-year follow-ups. Similarly, RVEF increased significantly from baseline to the 5-year follow-up (Early group: 5.4%, 95% CI:1.0–9.6; and Late group: 8.4%, 95% CI:4.5–12.3). Lower baseline levels of myocardial viability of the treated cardiac area (6.3±2.4 vs 8.2±3.0 mV, p<0.05) were associated with incidence of MACCE.ConclusionsPercutaneous combined delivery of autologous BM-MNCs is feasible and safe after 5 years, and may result in sustained improvement of cardiac function at 5 years in patients with low EF post-AMI (Clinicaltrials.gov NCT01395212).
Highlights
Recent meta-analyses of randomized clinical studies including patients with acute myocardial infarction (AMI) treated with/without intracoronary delivery of autologous bone marrow (BM) mononuclear cells (MNC) introduced debate about the efficacy of this cardiac regenerative treatment mode [1,2]
Five-Year Follow-Up of MYSTAR Study significant left ventricular (LV)-ejection fraction (EF) increase at 1-year follow-up was preserved at the 5-year control, with no significant changes between 1- and 5-year followups
We investigated the 5-year clinical outcome, LV and Right ventricular (RV) systolic and LV diastolic function, and infarct size in patients included in the MYSTAR study
Summary
Recent meta-analyses of randomized clinical studies including patients with acute myocardial infarction (AMI) treated with/without intracoronary delivery of autologous bone marrow (BM) mononuclear cells (MNC) introduced debate about the efficacy of this cardiac regenerative treatment mode [1,2]. Treatment of patients with chronic ischemic heart failure receiving either intracoronary or intramyocardial delivery of cells of diverse type (BM-MNC, autologous or allogeneic BM, or adipose tissue-derived mesenchymal stem cells) seems to be efficient in terms of significant increases in global left ventricular (LV) ejection fraction (EF) as shown by recently published meta-analyses [3,4]. Our MYSTAR, prospective, singleblind study included patients with recent AMI randomized to receive combined (intramyocardial followed by intracoronary) autologous BM-MNCs injections early (3–6 weeks, BM-MNC Early group) or late (3–4 months BM-MNC Late group) post-AMI with the aim of exploiting the advantages of both delivery modes [5]. The initial study was completed with a 1-year follow-up in 2008 [5,10,11], demonstrating moderate but significant improvement in infarct size and LV function [5]
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