Routine Spironolactone in Acute Myocardial Infarction
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu klinické zkoušky, fáze III, časopisecké články, multicentrická studie, randomizované kontrolované studie
PubMed
39555814
DOI
10.1056/nejmoa2405923
Knihovny.cz E-zdroje
- MeSH
- antagonisté mineralokortikoidních receptorů aplikace a dávkování škodlivé účinky MeSH
- cévní mozková příhoda * epidemiologie etiologie prevence a kontrola MeSH
- dvojitá slepá metoda MeSH
- incidence MeSH
- infarkt myokardu * komplikace mortalita terapie MeSH
- Kaplanův-Meierův odhad MeSH
- kardiovaskulární nemoci * mortalita prevence a kontrola MeSH
- kolchicin aplikace a dávkování škodlivé účinky MeSH
- koronární angioplastika MeSH
- lidé středního věku MeSH
- lidé MeSH
- následné studie MeSH
- prospektivní studie MeSH
- senioři MeSH
- spironolakton * aplikace a dávkování škodlivé účinky MeSH
- srdeční selhání * epidemiologie etiologie prevence a kontrola MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- antagonisté mineralokortikoidních receptorů MeSH
- kolchicin MeSH
- spironolakton * MeSH
BACKGROUND: Mineralocorticoid receptor antagonists have been shown to reduce mortality in patients after myocardial infarction with congestive heart failure. Whether routine use of spironolactone is beneficial after myocardial infarction is uncertain. 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.).
B P Koirala Institute of Health Sciences Dharan Nepal
Cardiology Department University Hospital La Paz Madrid
Caril and Edyth Lindner Center for Research and Education Christ Hospital Health Network Cincinnati
Centre Hospitalier Universitaire de Sherbrooke Sherbrooke QC Canada
Clinical Hospital Tetovo Tetovo North Macedonia
Department of Cardiology Peninsula Health Frankston VIC Australia
Department of Medicine University of Saskatchewan Moose Jaw Canada
Division of Clinical Medicine University of Sheffield Sheffield United Kingdom
Dutch Network for Cardiovascular Research Utrecht the Netherlands
Hamilton Health Sciences Hamilton ON Canada
Institut za Kardiovaskularne Bolesti Dedinje Belgrade Belgrade Serbia
London Health Sciences Centre University of Western Ontario London Canada
Northwest Clinics Alkmaar the Netherlands
Peninsula Clinical School Central Clinical School Monash University Melbourne VIC Australia
Population Health Research Institute McMaster University Hamilton ON Canada
Quebec Heart Lung Institute Laval University Quebec QC Canada
Radboud University Medical Center Nijmegen the Netherlands
Southlake Regional Health Centre Newmarket University of Toronto Toronto
St Mary's Hospital Kitchener ON Canada
University Clinical Center of Serbia and Faculty of Medicine University of Belgrade Belgrade
Citace poskytuje Crossref.org
ClinicalTrials.gov
NCT03048825
