Intracoronary administration of darbepoetin-alpha at onset of reperfusion in acute myocardial infarction: results of the randomized Intra-Co-EpoMI trial
François Roubille, Antoine Micheau, Stéphane Combes, Séverine Thibaut, Géraud Souteyrand, Guillaume Cayla, Laurent Bonello, Nathalie Lesavre, Catherine Sportouch-Dukhan, François Klein, Samir Berboucha, Stéphane Cade, Thien-Tri Cung, Franck Raczka, Jean-Christophe Macia, Richard Gervasoni, Frédéric Cransac, Florence Leclercq, Stéphanie Barrère-Lemaire, Franck Paganelli, Pascal Mottref, Hélène Vernhet Kovacsik, Michel Ovize, Christophe Piot, François Roubille, Antoine Micheau, Stéphane Combes, Séverine Thibaut, Géraud Souteyrand, Guillaume Cayla, Laurent Bonello, Nathalie Lesavre, Catherine Sportouch-Dukhan, François Klein, Samir Berboucha, Stéphane Cade, Thien-Tri Cung, Franck Raczka, Jean-Christophe Macia, Richard Gervasoni, Frédéric Cransac, Florence Leclercq, Stéphanie Barrère-Lemaire, Franck Paganelli, Pascal Mottref, Hélène Vernhet Kovacsik, Michel Ovize, Christophe Piot
Abstract
Background: Several trials investigating erythropoietin as a novel cytoprotective agent in myocardial infarction (MI) failed to translate promising preclinical results into the clinical setting. These trials could have missed crucial events occurring in the first few minutes of reperfusion. Our study differs by earlier intracoronary administration of a longer-acting erythropoietin analogue at the onset of reperfusion.
Aim: To evaluate the ability of intracoronary administration of darbepoetin-alpha (DA) at the very onset of the reperfusion, to decrease infarct size (IS).
Methods: We randomly assigned 56 patients with acute ST-segment elevation MI to receive an intracoronary bolus of DA 150 μg (DA group) or normal saline (control group) at the onset of reflow obtained by primary percutaneous coronary intervention (PCI). IS and area at risk (AAR) were evaluated by biomarkers, cardiac magnetic resonance (CMR) and validated angiographical scores.
Results: There was no difference between groups regarding duration of ischemia, Thrombolysis in Myocardial Infarction flow grade at admission and after PCI, AAR size and extent of the collateral circulation, which are the main determinants of IS. The release of creatine kinase was not significantly different between the two groups even when adjusted to AAR size. Between 3-7 days and at 3 months, the area of hyperenhancement on CMR expressed as a percentage of the left ventricular myocardium was not significantly reduced in the DA group even when adjusted to AAR size.
Conclusion: Early intracoronary administration of a longer-acting erythropoietin analogue in patients with acute MI at the time of reperfusion does not significantly reduce IS.
Trial registration: ClinicalTrials.gov NCT01043991.
Copyright © 2012 Elsevier Masson SAS. All rights reserved.
Source: PubMed