Effect of EPO administration on myocardial infarct size in patients with non-STE acute coronary syndromes; results from a pilot study Anho Liem a, ⁎ , Anton P. van de Woestijne a,b , Erik Bruijns a , Henk W.O. Roeters van Lennep a , Job A.J. de Boo a , Henk K. van Halteren a , Teun P. van Es a , J. Wouter Jukema c , Arnoud van der Laarse c , Aeilko H. Zwinderman d , Dirk J. van Veldhuisen e a Oosterschelde Ziekenhuizen, Goes, The Netherlands b Roosevelt Academy, Middelburg, The Netherlands c Leiden University Medical Center, Leiden, The Netherlands d Academic Medical Center, Amsterdam, The Netherlands e University Medical Center, Groningen, The Netherlands Received 9 June 2007; accepted 1 July 2007 Available online 1 November 2007 Abstract A pilot study was performed to determine the effect of 40,000 IU Epo on myocardial damage in 51 patients with non-ST segment elevation acute coronary syndrome (non-STE ACS). No significant difference in myocardial damage was found, but an increased systolic blood pressure was noticed. © 2007 Elsevier Ireland Ltd. All rights reserved. Keywords: Erythropoietin; Acute coronary syndrome; Infarct size ⁎ Corresponding author. Department of Cardiology, Oosterscheldezieken- huizen, Postbox 106, 4460 BB Goes, The Netherlands. Tel.: +31 113234000. E-mail address: anho@zeelandnet.nl (A. Liem). 1. Introduction Erythropoietin (Epo) is a hormone which is produced in liver and kidneys. It has a positive effect on erythropoiesis and is commonly used in nephrology and oncology patients. Experiments with rats [1–3] and dogs [4] have revealed that ischemic myocardial damage due to ligation of the left coronary artery can be decreased by previously treating the animals with a single dose of Epo. Proposed mechanisms of action are anti-apoptotic processes [2,4], neovascularization, mobilization of endothelial progenitor cells and angiogenesis [5,6]. The present prospective randomized placebo controlled clinical trial study was initiated to evaluate whether myocardial damage as measured enzymatically in patients with non-STE ACS and elevated troponin values can be reduced by a single intravenous dose of Epo, and to assess the safety of Epo treatment in ACS. 2. Methods Written informed consent was obtained from all patients before inclusion in the study. As soon as patients were known to have a non-STE ACS and a troponin I value ≥ 0.20 μg/L, they were eligible for this study. Within a maximal time window of 8 h after the elevated troponin I value was available, patients were randomly assigned to a single intravenous dose of 40,000 IU Epoietin-alpha or a matching placebo (saline). The protocol was approved by the Medical Ethics Committee of the Medical Center Rijnmond- Zuid. The study was conducted in full accordance with the principles of the “Declaration of Helsinki”, with ICH-GCP, and with the laws and regulations of The Netherlands. All sorts of concomitant medication were given according to the guidelines. The two treatment strategies were compared in terms of myocardial infarct size estimated on the basis of plasma CK and CK-MB mass levels and in terms of troponin I values. All patients were followed up to one and a half year for the occurrence of major adverse coronary events, strokes and other reasons for hospitalization. All complications, medication and invasive interventions during hospitalization were recorded, as was blood pressure change after Epo administration. For categorical variables, the data is given in percentages, for continuous variables, the data is given as mean ± standard 285 Letters to the Editor