Abstract | CONTEXT: OBJECTIVE: To evaluate the safety and efficacy of a single intravenous bolus of epoetin alfa in patients with STEMI. DESIGN, SETTING, AND PATIENTS: 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.
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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, REVEAL Investigators |
Journal | JAMA
(JAMA)
Vol. 305
Issue 18
Pg. 1863-72
(May 11 2011)
ISSN: 1538-3598 [Electronic] United States |
PMID | 21558517
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Intramural)
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Chemical References |
- Hematinics
- Placebos
- Recombinant Proteins
- Erythropoietin
- Epoetin Alfa
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Topics |
- Adult
- Age Factors
- Angioplasty, Balloon, Coronary
- Double-Blind Method
- Epoetin Alfa
- 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
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