Document Detail


Intravenous erythropoietin in patients with ST-segment elevation myocardial infarction: REVEAL: a randomized controlled trial.
MedLine Citation:
PMID:  21558517     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
CONTEXT: Acute ST-segment elevation myocardial infarction (STEMI) is a leading cause of morbidity and mortality. In experimental models of MI, erythropoietin reduces infarct size and improves left ventricular (LV) function.
OBJECTIVE: To evaluate the safety and efficacy of a single intravenous bolus of epoetin alfa in patients with STEMI.
DESIGN, SETTING, AND PATIENTS: A prospective, randomized, double-blind, placebo-controlled trial with a dose-escalation safety phase and a single dose (60,000 U of epoetin alfa) efficacy phase; the Reduction of Infarct Expansion and Ventricular Remodeling With Erythropoietin After Large Myocardial Infarction (REVEAL) trial was conducted at 28 US sites between October 2006 and February 2010, and included 222 patients with STEMI who underwent successful percutaneous coronary intervention (PCI) as a primary or rescue reperfusion strategy.
INTERVENTION: Participants were randomly assigned to treatment with intravenous epoetin alfa or matching saline placebo administered within 4 hours of reperfusion.
MAIN OUTCOME MEASURE: Infarct size, expressed as percentage of LV mass, assessed by cardiac magnetic resonance (CMR) imaging performed 2 to 6 days after study medication administration (first CMR) and again 12 ± 2 weeks later (second CMR).
RESULTS: In the efficacy cohort, the infarct size did not differ between groups on either the first CMR scan (n = 136; 15.8% LV mass [95% confidence interval {CI}, 13.3-18.2% LV mass] for the epoetin alfa group vs 15.0% LV mass [95% CI, 12.6-17.3% LV mass] for the placebo group; P = .67) or on the second CMR scan (n = 124; 10.6% LV mass [95% CI, 8.4-12.8% LV mass] vs 10.4% LV mass [95% CI, 8.5-12.3% LV mass], respectively; P = .89). In a prespecified analysis of patients aged 70 years or older (n = 21), the mean infarct size within the first week (first CMR) was larger in the epoetin alfa group (19.9% LV mass; 95% CI, 14.0-25.7% LV mass) than in the placebo group (11.7% LV mass; 95% CI, 7.2-16.1% LV mass) (P = .03). In the safety cohort, of the 125 patients who received epoetin alfa, the composite outcome of death, MI, stroke, or stent thrombosis occurred in 5 (4.0%; 95% CI, 1.31%-9.09%) but in none of the 97 who received placebo (P = .04).
CONCLUSIONS: In patients with STEMI who had successful reperfusion with primary or rescue PCI, a single intravenous bolus of epoetin alfa within 4 hours of PCI did not reduce infarct size and was associated with higher rates of adverse cardiovascular events. Subgroup analyses raised concerns about an increase in infarct size among older patients.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00378352.
Authors:
Samer S Najjar; Sunil V Rao; Chiara Melloni; Subha V Raman; Thomas J Povsic; Laura Melton; Gregory W Barsness; Kristi Prather; John F Heitner; Rakhi Kilaru; Luis Gruberg; Vic Hasselblad; Adam B Greenbaum; Manesh Patel; Raymond J Kim; Mark Talan; Luigi Ferrucci; Dan L Longo; Edward G Lakatta; Robert A Harrington;
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Intramural    
Journal Detail:
Title:  JAMA     Volume:  305     ISSN:  1538-3598     ISO Abbreviation:  JAMA     Publication Date:  2011 May 
Date Detail:
Created Date:  2011-05-11     Completed Date:  2011-05-12     Revised Date:  2014-09-17    
Medline Journal Info:
Nlm Unique ID:  7501160     Medline TA:  JAMA     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1863-72     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00378352
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MeSH Terms
Descriptor/Qualifier:
Adult
Age Factors
Angioplasty, Balloon, Coronary
Double-Blind Method
Erythropoietin / administration & dosage*,  adverse effects*
Female
Hematinics / administration & dosage*,  adverse effects*
Humans
Injections, Intravenous
Magnetic Resonance Imaging
Male
Middle Aged
Myocardial Infarction / drug therapy*,  pathology
Myocardial Reperfusion
Myocardium / pathology
Placebos
Recombinant Proteins
Stents
Stroke
Thrombosis / chemically induced
Treatment Outcome
Ventricular Function, Left
Ventricular Remodeling
Grant Support
ID/Acronym/Agency:
ZIA AG000243-04/AG/NIA NIH HHS
Chemical
Reg. No./Substance:
0/Hematinics; 0/Placebos; 0/Recombinant Proteins; 11096-26-7/Erythropoietin; 113427-24-0/epoetin alfa
Investigator
Investigator/Affiliation:
Lawrence J Appel / ; Victor Ferrari / ; Mark D Kelemen / ; Jon R Resar / ; Michael L Terrin / ; Edgar R Miller /
Comments/Corrections
Comment In:
JAMA. 2011 Aug 17;306(7):705; author reply 706   [PMID:  21846848 ]
JAMA. 2011 Aug 17;306(7):705-6; author reply 706   [PMID:  21846847 ]
JAMA. 2011 May 11;305(18):1908-9   [PMID:  21558525 ]
Am J Kidney Dis. 2011 Dec;58(6):876-8   [PMID:  21962617 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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