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Colchicine in Acute Myocardial Infarction

SS. Jolly, MA. d'Entremont, SF. Lee, R. Mian, J. Tyrwhitt, S. Kedev, G. Montalescot, JH. Cornel, G. Stanković, R. Moreno, RF. Storey, TD. Henry, SR. Mehta, M. Bossard, P. Kala, J. Layland, B. Zafirovska, PJ. Devereaux, J. Eikelboom, JA. Cairns,...

. 2025 ; 392 (7) : 633-642. [pub] 20241117

Language English Country United States

Document type Journal Article, Randomized Controlled Trial, Multicenter Study

E-resources Online Full text

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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

Cardiology Division Heart Center Luzerner Katonsspital and Faculty of Health Sciences and Medicine University of Lucerne Lucerne Switzerland

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

Medical Faculty University Clinic of Cardiology University Ss Cyril and Methodius Skopje North Macedonia

NIHR Sheffield Biomedical Research Centre Sheffield Teaching Hospitals NHS Foundation Trust Sheffield United Kingdom

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

Sorbonne University ACTION Study Group Centre Hospitalier Universitaire Pitié Salpêtrière Assistance Publique Hôpitaux de Paris Paris

University Clinical Center of Serbia and Faculty of Medicine University of Belgrade Belgrade

University Hospital Brno Brno Czech Republic

University of British Columbia and Centre for Cardiovascular Innovation Vancouver Coastal Health Vancouver Canada

References provided by Crossref.org

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