Erythropoietin prevention trial of coronary restenosis and cardiac remodeling after ST-elevated acute myocardial infarction (EPOC-AMI): a pilot, randomized, placebo-controlled study

Circ J. 2010 Nov;74(11):2365-71. doi: 10.1253/circj.cj-10-0267. Epub 2010 Sep 8.

Abstract

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(+)/CD45(dim) 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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Angioplasty, Balloon, Coronary* / adverse effects
  • Biomarkers / blood
  • 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 / 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*

Substances

  • Biomarkers
  • Cardiovascular Agents
  • Hemoglobins
  • Recombinant Proteins
  • epoetin beta
  • Erythropoietin
  • Creatine Kinase

Associated data

  • ClinicalTrials.gov/NCT00423020