Abstract 4377: Safety and Feasibility of Erythropoietin Administration in Patients with Acute ST-Elevation Myocardial Infarction
BACKGROUND. Erythropoietin (Epo) may rescue ischemic myocardium through antiapoptotic effects, but its safety in patients (pts) with cardiac ischemia is uncertain. We report preliminary data from the Exogenous erythroPoietin in Acute Myocardial Infarction: New Outlook aNd Dose Association Study (EudraCT no. 2005–004853–86).
METHODS. This prospective, multicenter, randomized, double-bind, dose-finding trial is designed to assess the effects of human recombinant Epo (I.V. 100 or 200 IU/kg/d for 3 days) vs placebo on infarct size (assessed by CK-MB, echoCG and MRI) in 99–102 pts with first ST-elevation myocardial infarction (STEMI) treated by successful primary PCI within 8h of symptom onset. Cardiogenic shock, ventilatory support, Hb >16 or <11 g/dl, uncontrolled hypertension, cancer, recent PCI/trauma/surgery, creatinine clearance <30/ml/min, and age >80 yrs are further exclusion criteria.
RESULTS. Between August 2007 and May 2008, 37 pts have been enrolled (59.8±9.9 yrs, 27 men) and 268 excluded. STEMI location was anterior in 11, inferior in 17, and lateral in 9, with peak CK-MB = 287.7±205.0 ng/ml. Time from symptom onset to PCI was 256±239 min. TIMI flow post PCI was grade 3 in 32 pts and grade 2 in 5. In-hospital biochemical and clinical data (mean±SD) are shown in the Table⇓. Pre-specified in-hospital adverse events were 3 major bleeds (hemopericardium, hematemesis, severe anemia), 1 atrial flutter, and 1 stratified apical thrombus. During the 5.8±3.2 month follow-up there was 1 rehospitalization for recurrent ischemia. Unblinding will take place after complete data collection.
CONCLUSIONS: Triple I.V. dosing of Epo (100 or 200 IU/kg/d) in pts with acute STEMI is feasible, well tolerated and apparently safe. In particular, no unexpected hypertensive or clinical thromboembolic events were observed.