COLCOT
Trial question
What is the effect of low-dose colchicine in patients after a MI?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
19.0% female
81.0% male
N = 4745
4745 patients (909 female, 3836 male).
Inclusion criteria: adult patients who had a MI within 30 days of enrollment.
Key exclusion criteria: severe HF, stroke within the previous 3 months, IBD or chronic diarrhea, neuromuscular disease, severe renal disease, severe hepatic disease, a history of clinically significant sensitivity to colchicine.
Interventions
N=2366 colchicine (at a dose of 0.5 mg once daily).
N=2379 placebo (matching 0.5 mg sugar pill once daily).
Primary outcome
CV death, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina leading to coronary revascularization
5.5%
7.1%
7.1 %
5.3 %
3.5 %
1.8 %
0.0 %
Colchicine
Placebo
Significant
decrease ▼
NNT = 62
Significant decrease in CV death, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina leading to coronary revascularization (5.5% vs. 7.1%; HR 0.77, 95% CI 0.61 to 0.96).
Secondary outcomes
No significant difference in CV death, cardiac arrest, MI, or stroke (4.7% vs. 5.5%; HR 0.85, 95% CI 0.66 to 1.1).
No significant difference in DVT or PE (0.4% vs. 0.3%; HR 1.43, 95% CI 0.54 to 3.75).
Safety outcomes
No significant differences in adverse events, serious adverse events, diarrhea.
Significant differences in pneumonia (0.9% vs. 0.4%), nausea (1.8% vs. 1.0%).
Conclusion
In adult patients who had a MI within 30 days of enrollment, colchicine was superior to placebo with respect to CV death, resuscitated cardiac arrest, myocardial infarction, stroke, or urgent hospitalization for angina leading to coronary revascularization.
Reference
Jean-Claude Tardif, Simon Kouz, David D Waters et al. Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction. N Engl J Med. 2019 Dec 26;381(26):2497-2505.
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