Early eplerenone treatment in patients with acute ST-elevation myocardial infarction without heart failure: The Randomized Double-Blind Reminder Study - Université de Lorraine Access content directly
Journal Articles European Heart Journal Year : 2014

Early eplerenone treatment in patients with acute ST-elevation myocardial infarction without heart failure: The Randomized Double-Blind Reminder Study

Gilles Montalescot
Bertram Pitt
Christian Hamm
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Marcus Flather
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Harry Shi
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Eva Turgonyi
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Miguel Orri
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John B. Vincent
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G. Noll
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R. Weir
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B. O'Neill
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M. Bohm
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W. Hillis
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A. Grieve
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J. Rouleau
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F. Gerasimos
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D. Fitchett
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M. Madan
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B. Sussex
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G. Tremblay
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R. Welsh
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G. Wong
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M. Hutyra
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J. Kettner
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P. Ostadal
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J. Spinar
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J. Vojacek
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J. Collet
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P. Coste
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Y. Cottin
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D. Ducos
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E. Teiger
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G. Zemour
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J. Bauersachs
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R. Hambrecht
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G. Hauf
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H. Heuer
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H. Mudra
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T. Munzel
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S. Steiner
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R. Strasser
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K. Sydow
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C. Tschope
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R. Wachter
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N. Werner
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D. Alexopoulos
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D. Babalis
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V. Pyrgakis
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C. Dezsi
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G. Lupkovics
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P. Polgar
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J. Tomcsanyi
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J. Herrman
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J. ten Berg
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J. Kubica
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J. Lewczuk
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W. Zmuda
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M. Hranai
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F. Kovar
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R. Margoczy
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K. Micko
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J. Sumbal
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X. Genover
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A. Ortiz
F. Sala
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J. Rey Blas
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F. Soriano
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D. Adamson
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F. Alamgir
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A. Chauhan
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G. Lip
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T. Martin
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G. Mccann
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D. Newby
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D. Smith
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Abstract

AIMS: We aimed to assess the impact of eplerenone on cardiovascular (CV) outcomes in STEMI without known heart failure, when initiated within 24 h of symptom onset. METHODS AND RESULTS: In this randomized, placebo-controlled, double-blind trial, we assigned 1012 patients with acute STEMI and without a history of heart failure to receive either eplerenone (25-50 mg once daily) or placebo in addition to standard therapy. The primary endpoint was the composite of CV mortality, re-hospitalization, or, extended initial hospital stay, due to diagnosis of HF, sustained ventricular tachycardia or fibrillation, ejection fraction ≤40%, or elevated BNP/NT-proBNP at 1 month or more after randomization. BNP elevation was defined as BNP levels or values above 200 pg/mL or NT-proBNP values above 450 pg/mL (in patients aged below 50); above 900 pg/mL (age 50-75 years) or above 1800 pg/mL (patients older than 75). After a mean follow-up of 10.5 months, the primary endpoint occurred in 92 patients (18.2%) in the eplerenone group and in 149 patients (29.4%) in the placebo group [adjusted hazard ratio (HR), 0.58; 95% confidence interval (CI), 0.45-0.76; P < 0.0001]. The primary endpoint was driven by a high BNP/NT-proBNP level (adjusted HR, 0.60; 95% CI, 0.45-0.79; P < 0.0003). Adverse event rates were similar in both groups. Serum potassium levels exceeded 5.5 mmol/L in 5.6 vs. 3.2% (P = 0.09) and were below 3.5 mmol/L in 1.4 vs. 5.6% of patients (P = 0.0002), in the eplerenone and placebo groups, respectively. CONCLUSION: The addition of eplerenone during the acute phase of STEMI was safe and well tolerated. It reduced the primary endpoint over a mean 13 months follow-up mostly because of significantly lower BNP/NT-proBNP levels. Additional studies are needed to clarify the role of early use of MRAs in STEMI patients without heart failure. CLINICAL TRIAL REGISTRATION: NCT01176968.
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hal-01738642 , version 1 (25-10-2023)

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Gilles Montalescot, Bertram Pitt, Esteban Lopez de Sa, Christian Hamm, Marcus Flather, et al.. Early eplerenone treatment in patients with acute ST-elevation myocardial infarction without heart failure: The Randomized Double-Blind Reminder Study. European Heart Journal, 2014, 35 (34), pp.2295 - 2302. ⟨10.1093/eurheartj/ehu164⟩. ⟨hal-01738642⟩
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