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

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• 作者：Farzin Beygui ; MD ; PhD^a ; Guillaume Cayla ; MD ; PhD^b ; Vincent Roule ; MD^a ; Franç ; ois Roubille ; MD ; PhD^c ; Nicolas Delarche ; MD^d ; Johanne Silvain ; MD ; PhD^e ; Eric Van Belle ; MD ; PhD^f ; Loic Belle ; MD^g ; Michel Galinier ; MD^h ; Pascal Motreff ; MD ; PhDⁱ ; Luc Cornillet ; MD ; PhD^b ; Jean-Philippe Collet ; MD ; PhD^e ; Alain Furber ; MD ; PhD^j ; Patrick Goldstein ; MD^k ; Patrick Ecollan ; MD^l ; Damien Legallois ; MD^a ; Alain Lebon ; MD^a ; Hé ; lè ; ne Rousseau ; MSc^m ; Jacques Machecourt ; MDⁿ ; Faiez Zannad ; MD ; PhD^o ; Eric Vicaut ; MD ; PhD^m ; Gilles Montalescot ; MD ; PhD^e ; ^{gilles.montalescot@aphp.fr" class="auth_mail" title="E-mail the corresponding author} ; on behalf of the ALBATROSS Investigators
• 关键词：left ventricular dysfunction ; mineralocorticoid receptor antagonists ; mortality
• 刊名：Journal of the American College of Cardiology
• 出版年：2016
• 出版时间：26 April 2016
• 年：2016
• 卷：67
• 期：16
• 页码：1917-1927
• 全文大小：1098 K

文摘

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).