Abstract 5904: Single-dose Intravenous-administration of Recombinant Human Erythropoietin Considerably Improved Cardiac Function in Patients With Acute Myocardial Infarction: A Randomized Controlled Pilot Trial of EPO/AMI-I Study
Introduction: In addition to hematopoietic activity, erythropoietin (EPO) has revealed anti-apoptotic and tissue protective effects on the myocardium in animal models. We therefore planned a pilot clinical trial to observe the safety and efficacy of EPO-administration for patients with acute myocardial infarction (AMI).
Methods: Patients were eligible if they were admitted within 24 hours of the onset of symptoms of a first ST-segment elevation AMI. They had all undergone successful percutaneous coronary intervention (PCI) in an infarct-related artery. After acquisition of written informed consent, patients were randomly assigned to 2 groups (control and EPO groups), and intraveneously administered with 12,000 IU of epoetin-beta or with physiological saline within 24 hours after PCI. The primary endpoints were the safety of EPO-administration and the efficacy, i.e., the difference between the acute phase and chronic phase (6 months after the attack) regarding left ventricular function measured as by ECG gated 99mTc-hexakis-2-methoxy-isobutyl isonitrile single photon emission computed tomography.
Results: From December 2005 to March 2008, forty-one consecutive patients with AMI (control 19, EPO 22) were enrolled in this trial. Among the patients, 36 (control 16, EPO 20) were eligible for analysis. Global left ventricular ejection fraction (LVEF) significantly increased in the EPO group (baseline: 51.0±19.6%, 6 month: 58.5±15.0%, p=0.0238), but not in the control group (baseline: 47.2±16.2% 6Ms: 51.3±18.2%, p=0.2292). Further analysis was separately undertaken in patients with occlusion in the left anterior descending artery (LAD) and others (non-LAD). LVEF (baseline and 6Ms) in the control and EPO groups were 35.3±8.1% and 40.8±14.9% (n=9), p=0.3594, and 37.5±13.0% and 52.7±15.8% (11), p=0.0049 in LAD patients, and 62.4±9.3% and 64.9±12.5% (7), p=0.5625, and 67.4±12.2% and 65.6±11.0% (9), p=0.4609 in non-LAD patients, respectively. EPO-administration did not trigger any adverse clinical events such as in-stent restenosis or arrhythmia.
Conclusions: EPO-administration improved cardiac function in 6Ms without triggering adverse events. A larger scale phase II/III clinical trial, EPO/AMI-II study, will start in autumn 2009.