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


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.
Taniguchi
Norimasa
N
Department of Cardiology, Sakurakai Takahashi Hospital, Kobe, Japan.
Nakamura
Takeshi
T
Sawada
Takahisa
T
Matsubara
Kinya
K
Furukawa
Keizo
K
Hadase
Mitsuyoshi
M
Nakahara
Yoshifumi
Y
Nakamura
Takashi
T
Matsubara
Hiroaki
H
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects; D015415:Biomarkers / Q000097:blood; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D016009:Chi-Square Distribution; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D003402:Creatine Kinase / Q000097:blood; D042783:Endothelial Cells / Q000187:drug effects / Q000473:pathology; D004921:Erythropoietin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D006965:Hyperplasia; D007564:Japan; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D009206:Myocardium / Q000473:pathology; D010865:Pilot Projects; D015990:Placebo Effect; D011446:Prospective Studies; D011994:Recombinant Proteins; D013234:Stem Cells / Q000187:drug effects / Q000473:pathology; D013318:Stroke Volume / Q000187:drug effects; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional; D016277:Ventricular Function, Left / Q000187:drug effects; D020257:Ventricular Remodeling / Q000187:drug effects*
D015415:Biomarkers; D002317:Cardiovascular Agents; D006454:Hemoglobins; D011994:Recombinant Proteins; C103998:epoetin beta; D004921:Erythropoietin; D003402:Creatine Kinase