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Randomized Controlled Trial
. 2020 Nov 5;383(19):1838-1847.
doi: 10.1056/NEJMoa2021372. Epub 2020 Aug 31.

Colchicine in Patients with Chronic Coronary Disease

Stefan M Nidorf  1 , Aernoud T L Fiolet  1 , Arend Mosterd  1 , John W Eikelboom  1 , Astrid Schut  1 , Tjerk S J Opstal  1 , Salem H K The  1 , Xiao-Fang Xu  1 , Mark A Ireland  1 , Timo Lenderink  1 , Donald Latchem  1 , Pieter Hoogslag  1 , Anastazia Jerzewski  1 , Peter Nierop  1 , Alan Whelan  1 , Randall Hendriks  1 , Henk Swart  1 , Jeroen Schaap  1 , Aaf F M Kuijper  1 , Maarten W J van Hessen  1 , Pradyot Saklani  1 , Isabel Tan  1 , Angus G Thompson  1 , Allison Morton  1 , Chris Judkins  1 , Willem A Bax  1 , Maurits Dirksen  1 , Marco Alings  1 , Graeme J Hankey  1 , Charley A Budgeon  1 , Jan G P Tijssen  1 , Jan H Cornel  1 , Peter L Thompson  1 ; LoDoCo2 Trial Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Colchicine in Patients with Chronic Coronary Disease

Stefan M Nidorf et al. N Engl J Med. .

Abstract

Background: Evidence from a recent trial has shown that the antiinflammatory effects of colchicine reduce the risk of cardiovascular events in patients with recent myocardial infarction, but evidence of such a risk reduction in patients with chronic coronary disease is limited.

Methods: In a randomized, controlled, double-blind trial, we assigned patients with chronic coronary disease to receive 0.5 mg of colchicine once daily or matching placebo. The primary end point was a composite of cardiovascular death, spontaneous (nonprocedural) myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization. The key secondary end point was a composite of cardiovascular death, spontaneous myocardial infarction, or ischemic stroke.

Results: A total of 5522 patients underwent randomization; 2762 were assigned to the colchicine group and 2760 to the placebo group. The median duration of follow-up was 28.6 months. A primary end-point event occurred in 187 patients (6.8%) in the colchicine group and in 264 patients (9.6%) in the placebo group (incidence, 2.5 vs. 3.6 events per 100 person-years; hazard ratio, 0.69; 95% confidence interval [CI], 0.57 to 0.83; P<0.001). A key secondary end-point event occurred in 115 patients (4.2%) in the colchicine group and in 157 patients (5.7%) in the placebo group (incidence, 1.5 vs. 2.1 events per 100 person-years; hazard ratio, 0.72; 95% CI, 0.57 to 0.92; P = 0.007). The incidence rates of spontaneous myocardial infarction or ischemia-driven coronary revascularization (composite end point), cardiovascular death or spontaneous myocardial infarction (composite end point), ischemia-driven coronary revascularization, and spontaneous myocardial infarction were also significantly lower with colchicine than with placebo. The incidence of death from noncardiovascular causes was higher in the colchicine group than in the placebo group (incidence, 0.7 vs. 0.5 events per 100 person-years; hazard ratio, 1.51; 95% CI, 0.99 to 2.31).

Conclusions: In a randomized trial involving patients with chronic coronary disease, the risk of cardiovascular events was significantly lower among those who received 0.5 mg of colchicine once daily than among those who received placebo. (Funded by the National Health Medical Research Council of Australia and others; LoDoCo2 Australian New Zealand Clinical Trials Registry number, ACTRN12614000093684.).

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