Design and rationale of the Reduction of Infarct Expansion and Ventricular Remodeling with Erythropoietin after Large Myocardial Infarction (REVEAL) trial

Melloni, Chiara; Rao, Sunil V.; Povsic, Thomas J.; Melton, Laura G.; Kim, Raymond J.; Kilaru, Rakhi; Patel, Manesh R.; Talan, Mark I.; Ferrucci, Luigi; Longo, Dan L.; Lakatta, Edward G.; Najjar, Samer S.; Harrington, Robert A.

doi:10.1016/j.ahj.2010.09.007

Cited by 19 publications

(25 citation statements)

References 58 publications

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“…[1][2][3][4][5][6][7][8] Therefore, it would seem to be a logical agent to test prospectively in a trial of acute myocardial infarction (MI). 9 In this issue of JAMA, Najjar and colleagues 10 report the results of the Reduction of Infarct Expansion and Ventricular Remodeling With Erythropoietin After Large Myocardial Infarction (REVEAL) study, a rigorous randomized, double-blind, placebo-controlled phase 2 trial of a single bolus of intravenous epoetin alfa in 222 patients with ST-segment elevation MI (STEMI) who underwent successful percutaneous coronary intervention (PCI). Infarct size, the primary end point of this study, was assessed by cardiac magnetic resonance (CMR) imaging, which is a sensitive tool for this purpose.…”

Section: R Eduction Of Myocardial Infarct Size Remainsmentioning

confidence: 98%

Evaluation of Agents to Reduce Infarct Size

Bhatt¹

2011

JAMA

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Section: R Eduction Of Myocardial Infarct Size Remainsmentioning

confidence: 98%

Evaluation of Agents to Reduce Infarct Size

Bhatt¹

2011

JAMA

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“…No improvement on cardiac function or reduction in infarct size was observed in A Randomized, Double-Blind, Placebo-Controlled Trial of Erythropoietin in Patients with ST-Segment Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention (REVIVAL-3), which was another prospective, randomized, double-blind, placebo-controlled trial of EPO in patients with acute MI (87). Currently, the Reduction of Infarct Expansion and Ventricular Remodeling with Erythropoietin after Large Myocardial Infarction Trial (REVEAL) and Exogenous erythroPoietin in Acute Myocardial Infarction: New Outlook aNd Dose Association Study (EPAMINONDAS) trials are ongoing (2,76). Table 2 shows a summary of clinical studies with EPO in infarcted patients.…”

Section: Cytokine Therapymentioning

confidence: 98%

Gene and cytokine therapy for heart failure: molecular mechanisms in the improvement of cardiac function

Nagai

Komuro

2012

American Journal of Physiology-Heart and Circulatory Physiology

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Despite significant advances in pharmacological and clinical treatment, heart failure (HF) remains a leading cause of morbidity and mortality worldwide. Many new therapeutic strategies, including cell transplantation, gene delivery, and cytokines or other small molecules, have been explored to treat HF. Recent advancement of our understanding of the molecules that regulate cardiac function uncover many of the therapeutic key molecules to treat HF. Furthermore, a theory of paracrine mechanism, which underlies the beneficial effects of cell therapy, leads us to search novel target molecules for genetic or pharmacological strategy. Gene therapy means delivery of genetic materials into cells to achieve therapeutic effects. Recently, gene transfer technology in the cardiovascular system has been improved and several therapeutic target genes have been started to examine in clinical research, and some of the promising results have been emerged. Among the various bioactive reagents, cytokines such as granulocyte colony-stimulating factor and erythropoietin have been well examined, and a number of clinical trials for acute myocardial infarction and chronic HF have been conducted. Although further research is needed in both preclinical and clinical areas in terms of molecular mechanisms, safety, and efficiency, both gene and cytokine therapy have a great possibility to open the new era of the treatment of HF.

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“…Because of uncertainties both about optional dosage of erythropoietin and about its safety, the study was designed to consist of two phases, effectively incorporating a dose escalation strategy into the first component [2]. Epoetin α was administered intravenously in STEMI patients, and affects on infarct size determined by cardiac MRI imaging.…”

Section: Revealmentioning

confidence: 99%

Clinical Trials Update AHA Congress 2010

Horowitz

Rosenson

McMurray

et al. 2011

Cardiovasc Drugs Ther

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The clinical trials described in this article were presented at the Late Breaking Trials and the Clinical Science: Clinical Reports sessions of the American Heart Association Congress held in November 2010 in Chicago. The sessions and topics chosen for this article reflect the scope of interest of Cardiovascular Drugs and Therapy. The presentations should be considered preliminary, as further analyses may be done, which could alter the final publication of the results of these studies. PROTECT (ProBNP Outpatient Tailored Chronic Heart Failure Therapy) was designed to test the hypothesis that adjustment of intensity of chronic heart failure (HF) therapy on the basis of NT-proBNP plasma level monitoring would improve outcomes. The results provided some support of this concept, but needs further evaluation in larger, blinded trials. REVEAL (Reduction of Infarct Expansion and Ventricular Remodeling with erythropoietin after large myocardial infarctions) evaluated in the clinical setting of ischemia-reperfusion following STEMI that erythropoietin could salvage ischemic myocardium. The results did not show a reduction in infarct size, but, in contrast, an increase in adverse event rates in the erythropoietin group. GRAVITAS (Gauging Responsiveness with a VerifyNow assay-Impact on Thrombosis and Safety trial) investigated the effect of a standard vs. high maintenance clopidogrel dose in patients with stable myocardial ischemia or NSTEMI and drug-eluting stent insertion. Patients with high PRU values as determined by VerfyNow assay were randomized to 75 mg or 150 mg clopidogrel daily. The study did not show a significant difference in primary event rate between both groups. The Cholesterol Treatment Trialists' Collaboration Studies group evaluated the concept proposed in the JUPITER study that HDL levels on statin treatment may not provide useful prognostic information. The CTTC in a large sample size of statin-treated patients observed, on the contrary, a significantly increased risk of CV events, even in patients with low LDL cholesterol levels. DEFINE (Determining the Efficacy and Tolerability of CETP inhibition with Anacetrapib) evaluated possible safety aspects with the CETP inhibitor anacetrapib (increase in blood pressure). The study did not show adverse safety aspects, but significantly reduced LDL cholesterol and increased HDL cholesterol levels. ASSERT, a phase 2 dose-ranging study, investigated whether RVX-208 would increase Apo-A1 production. Apo-A1 may induce cholesterol efflux from macrophages and facilitate atherosclerosis regression. The study did not meet its primary endpoint, but significant prominent effects on lipids were found. ASCEND-HF was a large trial of nesiritide in >7000 patients with acute heart failure. The study did not show convincing symptom benefit, but on the other hand did not show harmful effects of nesiritide. EMPHASIS-HF evaluated the long term effects of eplerenone in patients with mild (NYHA class II) heart failure and systolic dysfunction. The study was prematurely ended because ...

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Design and rationale of the Reduction of Infarct Expansion and Ventricular Remodeling with Erythropoietin after Large Myocardial Infarction (REVEAL) trial

Cited by 19 publications

References 58 publications

Evaluation of Agents to Reduce Infarct Size

Evaluation of Agents to Reduce Infarct Size

Gene and cytokine therapy for heart failure: molecular mechanisms in the improvement of cardiac function

Clinical Trials Update AHA Congress 2010

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