Colchicine in Acute Myocardial Infarction
Language English Country United States Media print-electronic
Document type Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial
PubMed
39555823
DOI
10.1056/nejmoa2405922
Knihovny.cz E-resources
- MeSH
- C-Reactive Protein analysis MeSH
- Double-Blind Method MeSH
- Incidence MeSH
- Non-ST Elevated Myocardial Infarction * complications immunology mortality therapy MeSH
- ST Elevation Myocardial Infarction * complications immunology mortality therapy MeSH
- Kaplan-Meier Estimate MeSH
- Cardiovascular Diseases * blood epidemiology immunology prevention & control MeSH
- Colchicine * administration & dosage adverse effects MeSH
- Percutaneous Coronary Intervention MeSH
- Middle Aged MeSH
- Humans MeSH
- Follow-Up Studies MeSH
- Prospective Studies MeSH
- Diarrhea chemically induced epidemiology MeSH
- Recurrence MeSH
- Aged MeSH
- Spironolactone administration & dosage adverse effects MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- C-Reactive Protein MeSH
- Colchicine * MeSH
- Spironolactone MeSH
BACKGROUND: Inflammation is associated with adverse cardiovascular events. Data from recent trials suggest that colchicine reduces the risk of cardiovascular events. METHODS: In this multicenter trial with a 2-by-2 factorial design, we randomly assigned patients who had myocardial infarction to receive either colchicine or placebo and either spironolactone or placebo. The results of the colchicine trial are reported here. The primary efficacy outcome was a composite of death from cardiovascular causes, recurrent myocardial infarction, stroke, or unplanned ischemia-driven coronary revascularization, evaluated in a time-to-event analysis. C-reactive protein was measured at 3 months in a subgroup of patients, and safety was also assessed. RESULTS: A total of 7062 patients at 104 centers in 14 countries underwent randomization; at the time of analysis, the vital status was unknown for 45 patients (0.6%), and this information was most likely missing at random. A primary-outcome event occurred in 322 of 3528 patients (9.1%) in the colchicine group and 327 of 3534 patients (9.3%) in the placebo group over a median follow-up period of 3 years (hazard ratio, 0.99; 95% confidence interval [CI], 0.85 to 1.16; P = 0.93). The incidence of individual components of the primary outcome appeared to be similar in the two groups. The least-squares mean difference in C-reactive protein levels between the colchicine group and the placebo group at 3 months, adjusted according to the baseline values, was -1.28 mg per liter (95% CI, -1.81 to -0.75). Diarrhea occurred in a higher percentage of patients with colchicine than with placebo (10.2% vs. 6.6%; P<0.001), but the incidence of serious infections did not differ between groups. CONCLUSIONS: Among patients who had myocardial infarction, treatment with colchicine, when started soon after myocardial infarction and continued for a median of 3 years, did not reduce the incidence of the composite primary outcome (death from cardiovascular causes, recurrent myocardial infarction, stroke, or unplanned ischemia-driven coronary revascularization). (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
Department of Cardiology Peninsula Health Frankston VIC Australia
Department of Medicine University of Saskatchewan Moose Jaw Canada
Division of Cardiology Department of Medicine NYU Grossman School of Medicine New York
Division of Clinical Medicine University of Sheffield Sheffield United Kingdom
Dutch Network for Cardiovascular Research Utrecht the Netherlands
Hamilton Health Sciences Hamilton ON Canada
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
Radboud University Medical Center Nijmegen the Netherlands
Section of Cardiology Department of Medicine VA New York Harbor Healthcare System New York
University Clinical Center of Serbia and Faculty of Medicine University of Belgrade Belgrade
References provided by Crossref.org
ClinicalTrials.gov
NCT03048825
