Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction.
Level 2 - randomized trial
Individual multicenter randomized controlled trial
PubMed 31733140 · doi:10.1056/NEJMoa1912388
What was done
In a multicenter, randomized, double-blind trial (COLCOT), 4,745 patients recruited within 30 days after a myocardial infarction were randomly assigned to receive low-dose colchicine (0.5 mg once daily; n = 2,366) or placebo (n = 2,379). Patients were followed for a median of 22.6 months. The primary efficacy end point was a composite of death from cardiovascular causes, resuscitated cardiac arrest, myocardial infarction, stroke, or urgent hospitalization for angina leading to coronary revascularization.
What was found
The primary end point occurred in 5.5% of patients in the colchicine group compared with 7.1% in the placebo group (HR 0.77; 95% CI, 0.61 to 0.96; P = 0.02). For individual components, hazard ratios were: - Death from cardiovascular causes: 0.84 (95% CI, 0.46 to 1.52) - Resuscitated cardiac arrest: 0.83 (95% CI, 0.25 to 2.73) - Myocardial infarction: 0.91 (95% CI, 0.68 to 1.21) - Stroke: 0.26 (95% CI, 0.10 to 0.70) - Urgent hospitalization for angina leading to coronary revascularization: 0.50 (95% CI, 0.31 to 0.81) Diarrhea occurred in 9.7% of the colchicine group versus 8.9% of the placebo group (P = 0.35). Pneumonia as a serious adverse event occurred in 0.9% of colchicine-treated patients versus 0.4% in the placebo group (P = 0.03).
Why it matters
This trial demonstrates that targeting inflammation with low-dose colchicine provides clinical secondary prevention benefit, lowering recurrent ischemic event risk when initiated shortly after a myocardial infarction.
Limits
The primary composite benefit was largely driven by reductions in stroke and urgent revascularization for angina, while effects on cardiovascular death and recurrent MI were not individually statistically significant. Follow-up was limited to a median of 22.6 months, results apply specifically to patients within 30 days of MI, and colchicine was associated with a statistically significant increase in serious pneumonia events.