• Sanjit S Jolly, Marc-André d'Entremont, Shun Fu Lee, Rajibul Mian, Jessica Tyrwhitt, Sasko Kedev, Gilles Montalescot, Jan H Cornel, Goran Stanković, Raul Moreno, Robert F Storey, Timothy D Henry, Shamir R Mehta, Matthias Bossard, Petr Kala, Jamie Layland, Biljana Zafirovska, P J Devereaux, John Eikelboom, John A Cairns, Binita Shah, Tej Sheth, Sanjib K Sharma, Wadea Tarhuni, David Conen, Sarah Tawadros, Shahar Lavi, Salim Yusuf, and CLEAR Investigators.
• From the Population Health Research Institute, McMaster University (S.S.J., M.-A.E., S.F.L., R. Mian, J.T., S.R.M., P.J.D., J.E., T.S., D.C., S.T., S.Y.), and Hamilton Health Sciences (S.S.J., M.-A.E., S.F.L., R. Mian, S.R.M., P.J.D., J.E., T.S., D.C.), Hamilton, Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke (M.-A.E.), the University of British Columbia and Centre for Cardiovascular Innovation, Vancouver Coastal Health, Vancouver (J.A.C.), the Department of Medicine, University of Saskatchewan, Saskatoon (W.T.), and London Health Sciences, University of Western Ontario, London (S.L.) - all in Canada; the University Clinic of Cardiology, Medical Faculty, University Ss. Cyril and Methodius, Skopje, North Macedonia (S.K., B.Z.); Sorbonne University, ACTION Study Group, Centre Hospitalier Universitaire Pitié-Salpêtrière Assistance Publique-Hopitaux de Paris, Paris (G.M.); the Dutch Network for Cardiovascular Research, Utrecht, Radboud University Medical Center, Nijmegen, and Northwest Clinics, Alkmaar - all in the Netherlands (J.H.C.); the University Clinical Center of Serbia and the Faculty of Medicine, University of Belgrade, Belgrade (G.S.); the Cardiology Department, University Hospital La Paz, Universidad Autónoma de Madrid, Madrid (R. Moreno); NIHR Sheffield Biomedical Research Centre, Sheffield Teaching Hospitals NHS Foundation Trust, and the Division of Clinical Medicine, University of Sheffield - both in Sheffield, United Kingdom (R.F.S.); the Caril and Edyth Lindner Center for Research and Education, Christ Hospital Health Network, Cincinnati (T.D.H.); the Cardiology Division, Heart Center, Luzerner Kantonsspital, and the Faculty of Health Sciences and Medicine, University of Lucerne, Lucerne, Switzerland (M.B.); University Hospital Brno, Brno, Czech Republic (P.K.); the Department of Cardiology, Peninsula Health, Frankston, VIC, and Peninsula Clinical School, Central Clinical School, Monash University, Melbourne, VIC - both in Australia (J.L.); the Division of Cardiology, Department of Medicine, NYU Grossman School of Medicine, and the Section of Cardiology, Department of Medicine, VA New York Harbor Healthcare System, New York (B.S.); and B.P. Koirala Institute of Health Sciences, Dharan, Nepal (S.K.S.).
• N. Engl. J. Med. 2024 Nov 17.

BackgroundInflammation is associated with adverse cardiovascular events. Data from recent trials suggest that colchicine reduces the risk of cardiovascular events.MethodsIn 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.ResultsA 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.ConclusionsAmong 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.).Copyright © 2024 Massachusetts Medical Society.

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