Erythropoietin Prevention Trial of Coronary Restenosis and Cardiac Remodeling After ST-Elevated Acute Myocardial Infarction (EPOC-AMI) A Pilot, Randomized, Placebo-Controlled Study

• Published in: Circulation Journal Vol. 74; no. 11; pp. 2365 - 2371
• Main Authors: Taniguchi, Norimasa, Nakamura, Takeshi, Sawada, Takahisa, Matsubara, Kinya, Furukawa, Keizo, Hadase, Mitsuyoshi, Nakahara, Yoshifumi, Nakamura, Takashi, Matsubara, Hiroaki
• Format: Journal Article
• Language: English
• Published: Japan The Japanese Circulation Society 01.11.2010
• Subjects: Acute myocardial infarction; Aged; Angioplasty, Balloon, Coronary - adverse effects; Biomarkers - blood; Cardiac function; Cardiovascular Agents - administration & dosage; Cardiovascular Agents - adverse effects; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis - diagnosis; Coronary Restenosis - etiology; Coronary Restenosis - prevention & control; Creatine Kinase - blood; Endothelial Cells - drug effects; Endothelial Cells - pathology; Erythropoietin; Erythropoietin - administration & dosage; Erythropoietin - adverse effects; Female; Hemoglobins - metabolism; Humans; Hyperplasia; Japan; Male; Middle Aged; Myocardial Infarction - diagnosis; Myocardial Infarction - physiopathology; Myocardial Infarction - therapy; Myocardium - pathology; Pilot Projects; Placebo Effect; Prospective Studies; Recombinant Proteins; Stem Cells - drug effects; Stem Cells - pathology; Stroke Volume - drug effects; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Ventricular Function, Left - drug effects; Ventricular Remodeling - drug effects; Japan
• ISSN: 1346-9843; 1347-4820
• DOI: 10.1253/circj.CJ-10-0267

Background: Erythropoietin (EPO) enhances re-endothelialization and anti-apoptotic action. Larger clinical studies to examine the effects of high-dose EPO are in progress in patients with acute myocardial infarction (AMI). Methods and Results: The aim of this multi-center pilot study was to investigate the effect of `low-dose EPO' (6,000 IU during percutaneous coronary intervention (PCI), 24 h and 48 h) in 35 patients with a first ST-elevated AMI undergoing PCI who was randomly assigned to EPO or placebo (saline) treatment. Neointimal volume, cardiac function and infarct size were examined in the acute phase and 6 months later (ClinicalTrials.gov identifier: NCT00423020). No significant regression in in-stent neointimal volume was observed, whereas left ventricular (LV) ejection fraction was significantly improved (49.2% to 55.7%, P=0.003) and LV end-systolic volume was decreased in the EPO group (47.7 ml to 39.0 ml, P=0.036). LV end-diastolic volume tended to be reduced from 90.2% to 84.5% (P=0.159), whereas in the control group it was inversely increased (91.7% to 93.7%, P=0.385). Infarction sizes were significantly reduced by 38.5% (P=0.003) but not in the control group (23.7%, P=0.051). Hemoglobin, peak creatine kinase values, and CD34+/CD133+/CD45dim endothelial progenitors showed no significant changes. No adverse events were observed during study periods. Conclusions: This is a first study demonstrating that short-term `low-dose' EPO to PCI-treated AMI patients did not prevent neointimal hyperplasia but rather improved cardiac function and infarct size without any clinical adverse effects. (Circ J 2010; 74: 2365-2371)