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Heart. 2018 Nov;104(22):1843-1849. doi: 10.1136/heartjnl-2018-312950. Epub 2018 Apr 25.

Individual participant data analysis of two trials on aldosterone blockade in myocardial infarction.

Author information

1
ACTION Study Group, Service de Cardiologie, Centre Hospitalier Universitaire de Caen, EA4650 Normandie Université, Caen, Basse-Normandie, France.
2
INSERM U1011 and Cardiology, Institut Coeur Poumon, CHRU de Lille, Lille, France.
3
SAMU, ACTION Study Group, Centre Hospitalier Universitaire Pitié-Salpêtrière, Paris, France.
4
Service de Cardiologie, Centre Hospitalier Universitaire de Grenoble, Grenoble, Rhône-Alpes, France.
5
Kerckhoff Clinic, Bad Nauheim, Germany.
6
La Paz University Hospital, Madrid, Spain.
7
Cardiology, University of East Anglia and Norfolk and Norwich University Hospital, Norwich, UK.
8
Hospital Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
9
ACTION Study Group, Unite de Recherche Clinique, Hôpital Lariboisière, Paris, France.
10
Inserm CIC 1433 and Cardiology, Centre Hospitalier Universitaire de Nancy, Vandœuvre-lès-Nancy, France.
11
University of Michigan Hospital, Ann Arbor, Michigan, USA.
12
Cardiology, Sorbonne Université-Paris 6, ACTION Study Group, Institut de Cardiologie (AP-HP), Centre Hospitalier Universitaire Pitié-Salpêtriėre, INSERM UMRS 1166, Paris, France.

Abstract

BACKGROUND:

Two recent randomised trials studied the benefit of mineralocorticoid receptor antagonists (MRAs) in ST-segment elevation myocardial infarction (STEMI) irrespective or in absence of heart failure. The studies were both undersized to assess hard clinical endpoints. A pooled analysis was preplanned by the steering committees.

METHODS:

We conducted a prespecified meta-analysis of patient-level data of patients with STEMI recruited in two multicentre superiority trials, randomised within 72 hours after symptom onset. Patients were allocated (1:1) to two MRA regimens: (1) an intravenous bolus of potassium canrenoate (200 mg) followed by oral spironolactone (25 mg once daily) versus standard therapy or (2) oral eplerenone (25-50 mg) versus placebo. The primary and key secondary outcomes, all-cause death and the composite of all-cause death or resuscitated sudden death, respectively, were assessed in the intention-to-treat population using a Cox model stratified on the study identifier.

RESULTS:

Patients were randomly assigned to receive (n=1118) or not the MRA regimen (n=1123). After a median follow-up time of 188 days, the primary and secondary outcomes occurred in 5 (0.4%) and 17 (1.5%) patients (adjusted HR (adjHR) 0.31, 95% CI 0.11 to 0.86, p=0.03) and 6 (0.5%) and 22 (2%) patients (adjHR 0.26, 95% CI 0.10 to 0.65, p=0.004) in the MRA and control groups, respectively. There were also trends towards lower rates of cardiovascular death (p=0.06) and ventricular fibrillation (p=0.08) in the MRA group.

CONCLUSION:

Our analysis suggests that compared with standard therapy, MRA regimens are associated with a reduction of death and death or resuscitated sudden death in STEMI.

KEYWORDS:

acute myocardial infarction

PMID:
29695512
DOI:
10.1136/heartjnl-2018-312950
[Indexed for MEDLINE]

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