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Early Aldosterone Blockade in Acute Myocardial Infarction: The ALBATROSS Randomized Clinical Trial.

ACTION Study Group, Service de Cardiologie, Centre Hospitalier Universitaire de Caen, Caen, France. ACTION Study Group, Service de Cardiologie, Centre Hospitalier Universitaire de Nimes, Nîmes, France. Service de Cardiologie, Centre Hospitalier Universitaire de Montpellier, Montpellier, France. Service de Cardiologie, Centre Hospitalier de Pau, Pau, France. ACTION Study Group, Institut de Cardiologie (AP-HP), Centre Hospitalier Universitaire Pitié-Salpêtriėre, Paris, France. Service de Cardiologie, Centre Hospitalier Universitaire de Lille, Lille, France. Service de Cardiologie, Centre Hospitalier d'Annecy, Annecy, France. Service de Cardiologie, Centre Hospitalier Universitaire de Toulouse, Toulouse, France. Service de Cardiologie, Centre Hospitalier Universitaire de Clermont Ferrand, Clermont Ferrand, France. Service de Cardiologie, Centre Hospitalier Universitaire d'Angers, Angers, France. Service d'Accueil des Urgences et SAMU, Centre Hospitalier Universitaire de Lille, Lille, France. ACTION Study Group, SAMU, Centre Hospitalier Universitaire Pitié-Salpêtrière, Paris, France. ACTION Study Group, Unite de Recherche Clinique, Hôpital Lariboisière, Paris, France. Service de Cardiologie, Centre Hospitalier Universitaire de Grenoble, Grenoble, France. INSERM, CIC 1433 et Pôle de Cardiologie, Centre Hospitalier Universitaire de Nancy, Nancy, France. ACTION Study Group, Institut de Cardiologie (AP-HP), Centre Hospitalier Universitaire Pitié-Salpêtriėre, Paris, France. Electronic address: gilles.montalescot@aphp.fr.

Journal of the American College of Cardiology. 2016;(16):1917-27
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Abstract

BACKGROUND Mineralocorticoid receptor antagonists (MRA) improve outcome in the setting of post-myocardial infarction (MI) heart failure (HF). OBJECTIVES The study sought to assess the benefit of an early MRA regimen in acute MI irrespective of the presence of HF or left ventricular (LV) dysfunction. METHODS We randomized 1,603 patients to receive an MRA regimen with a single intravenous bolus of potassium canrenoate (200 mg) followed by oral spironolactone (25 mg once daily) for 6 months in addition to standard therapy or standard therapy alone. The primary outcome of the study was the composite of death, resuscitated cardiac arrest, significant ventricular arrhythmia, indication for implantable defibrillator, or new or worsening HF at 6-month follow-up. Key secondary/safety outcomes included death and other individual components of the primary outcome and rates of hyperkalemia at 6 months. RESULTS The primary outcome occurred in 95 (11.8%) and 98 (12.2%) patients in the treatment and control groups, respectively (hazard ratio [HR]: 0.97; 95% confidence interval [CI]: 0.73 to 1.28). Death occurred in 11 (1.4%) and 17 (2.1%) patients in the treatment and control groups, respectively (HR: 0.65; 95% CI: 0.30 to 1.38). In a non-pre-specified exploratory analysis, the odds of death were reduced in the treatment group (3 [0.5%] vs. 15 [2.4%]; HR: 0.20; 95% CI: 0.06 to 0.70) in the subgroup of ST-segment elevation MI (n = 1,229), but not in non-ST-segment elevation MI (p for interaction = 0.01). Hyperkalemia >5.5 mmol/l(-1) occurred in 3% and 0.2% of patients in the treatment and standard therapy groups, respectively (p < 0.0001). CONCLUSIONS The study failed to show the benefit of early MRA use in addition to standard therapy in patients admitted for MI. (Aldosterone Lethal effects Blockade in Acute myocardial infarction Treated with or without Reperfusion to improve Outcome and Survival at Six months follow-up; NCT01059136).

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