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BACKG ROUND
Experimental and clinical evidence support the role of inflammation in atheroscle-
rosis and its complications. Colchicine is an orally administered, potent antinflam-
matory medication that is indicated for the treatment of gout and pericarditis.
METHODS
We performed a randomized, double-blind trial involving patients recruited within
30 days after a myocardial infarction. The patients were randomly assigned to receive
either low-dose colchicine (0.5 mg once daily) or placebo. The primary efficacy end
point was a composite of death from cardiovascular causes, resuscitated cardiac ar-
rest, myocardial infarction, stroke, or urgent hospitalization for angina leading to
coronary revascularization. The components of the primary end point and safety were
also assessed.
RESULTS
A total of 4745 patients were enrolled; 2366 patients were assigned to the colchicine
group, and 2379 to the placebo group. Patients were followed for a median of 22.6
months. The primary end point occurred in 5.5% of the patients in the colchicine
group, as compared with 7.1% of those in the placebo group (hazard ratio, 0.77; 95%
confidence interval [CI], 0.61 to 0.96; P=0.02). The hazard ratios were 0.84 (95% CI,
0.46 to 1.52) for death from cardiovascular causes, 0.83 (95% CI, 0.25 to 2.73) for
resuscitated cardiac arrest, 0.91 (95% CI, 0.68 to 1.21) for myocardial infarction, 0.26
(95% CI, 0.10 to 0.70) for stroke, and 0.50 (95% CI, 0.31 to 0.81) for urgent hospi-
talization for angina leading to coronary revascularization. Diarrhea was reported in
9.7% of the patients in the colchicine group and in 8.9% of those in the placebo
group (P=0.35). Pneumonia was reported as a serious adverse event in 0.9% of the
patients in the colchicine group and in 0.4% of those in the placebo group (P=0.03).
CONCLUSIONS
Among patients with a recent myocardial infarction, colchicine at a dose of 0.5 mg
daily led to a significantly lower risk of ischemic cardiovascular events than placebo.
(Funded by the Government of Quebec and others; COLCOT ClinicalTrials.gov num-
ber, NCT02551094.)
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