Routine Spironolactone in Acute Myocardial Infarction.
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Jolly Sanjit S, d'Entremont Marc-André, Pitt Bertram, Lee Shun Fu, Mian Rajibul, Tyrwhitt Jessica, Kedev Sasko, Montalescot Gilles, Cornel Jan H, Stanković Goran, Moreno Raul, Storey Robert F, Henry Timothy D, Mehta Shamir R, Bossard Matthias, Kala Petr, Bhindi Ravinay, Zafirovska Biljana, Devereaux P J, Eikelboom John, Cairns John A, Natarajan Madhu K, Schwalm J D, Sharma Sanjib K, Tarhuni Wadea, Conen David, Tawadros Sarah, Lavi Shahar, Asani Valon, Topic Dragan, Cantor Warren J, Bertrand Olivier F, Pourdjabbar Ali, Yusuf Salim, CLEAR investigators, CLEAR Investigators
Аннотация
METHODS: In this multicenter trial with a 2-by-2 factorial design, we randomly assigned patients with myocardial infarction who had undergone percutaneous coronary intervention to receive either spironolactone or placebo and either colchicine or placebo. The results of the spironolactone trial are reported here. The two primary outcomes were a composite of death from cardiovascular causes or new or worsening heart failure, evaluated as the total number of events; and a composite of the first occurrence of myocardial infarction, stroke, new or worsening heart failure, or death from cardiovascular causes. Safety was also assessed.
RESULTS: We enrolled 7062 patients at 104 centers in 14 countries; 3537 patients were assigned to receive spironolactone and 3525 to receive placebo. At the time of our analyses, the vital status was unknown for 45 patients (0.6%). For the first primary outcome, there were 183 events (1.7 per 100 patient-years) in the spironolactone group as compared with 220 events (2.1 per 100 patient-years) in the placebo group over a median follow-up period of 3 years (hazard ratio adjusted for competing risk of death from noncardiovascular causes, 0.91; 95% confidence interval [CI], 0.69 to 1.21; P = 0.51). With respect to the second primary outcome, an event occurred in 280 of 3537 patients (7.9%) in the spironolactone group and 294 of 3525 patients (8.3%) in the placebo group (hazard ratio adjusted for competing risk, 0.96; 95% CI, 0.81 to 1.13; P = 0.60). Serious adverse events were reported in 255 patients (7.2%) in the spironolactone group and 241 (6.8%) in the placebo group.
CONCLUSIONS: Among patients with myocardial infarction, spironolactone did not reduce the incidence of death from cardiovascular causes or new or worsening heart failure or the incidence of a composite of death from cardiovascular causes, myocardial infarction, stroke, or new or worsening heart failure. (Funded by the Canadian Institutes of Health Research and others; CLEAR ClinicalTrials.gov number, NCT03048825.).