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

Gilles Montalescot 1 Bertram Pitt 2 Esteban Lopez de Sa 3 Christian Hamm 4 Marcus Flather 5 Freek Verheugt 6 Harry Shi 7 Eva Turgonyi 8 Miguel Orri 8 John B. Vincent 7 Faiez Zannad 9 G. Noll R. Weir B. O'Neill M. Bohm W. Hillis A. Grieve J. Rouleau F. Gerasimos D. Fitchett S. Lepage 10 M. Madan B. Sussex G. Tremblay R. Welsh G. Wong M. Hutyra J. Kettner P. Ostadal J. Spinar J. Vojacek M. Barboteu 11 J. Collet P. Coste Y. Cottin 12 D. Ducos M. Galinier 13 E. Teiger G. Zemour J. Bauersachs R. Hambrecht G. Hauf H. Heuer H. Mudra T. Munzel S. Steiner R. Strasser K. Sydow C. Tschope R. Wachter N. Werner D. Alexopoulos D. Babalis V. Pyrgakis C. Dezsi G. Lupkovics P. Polgar J. Tomcsanyi J. Herrman J. ten Berg J. Gorny 14 J. Kubica J. Lewczuk W. Zmuda M. Hranai F. Kovar R. Margoczy K. Micko J. Sumbal X. Genover A. Ortiz F. Sala G. Garcia 15 C. Muñoz 16 J. Rey Blas F. Soriano D. Adamson F. Alamgir A. Chauhan G. Lip T. Martin G. Mccann D. Newby D. Smith 
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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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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