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COLCOT

"Colchicine in Patients with Recent Myocardial Infarction".The New England Journal of Medicine. 2019. DOI: 10.1056/NEJMoa1912388.

Clinical Question

Does low-dose colchicine reduce the risk of ischemic cardiovascular events in patients with a recent myocardial infarction?

Bottom Line

In patients with a recent myocardial infarction, low-dose colchicine (0.5 mg once daily) significantly reduced the occurrence of ischemic cardiovascular events compared with placebo.

Major Points

Guidelines

As of the knowledge cutoff date, no specific guidelines reflect the results of this trial.

Design

- Multicenter, double-blind, randomized, placebo-controlled trial
- N=4,745; 2,366 to colchicine, 2,379 to placebo
- Setting: 167 centers in 12 countries
- Enrollment: December 2015 - August 2018
- Follow-up: Median 22.6 months
- Analysis: Intention-to-treat
- Primary outcome: Composite of death from cardiovascular causes, resuscitated cardiac arrest, myocardial infarction, stroke, or urgent hospitalization for angina leading to coronary revascularization

Population

- Adult patients within 30 days post-myocardial infarction
- Completed planned percutaneous revascularization procedures
- Treated according to national guidelines including intensive statin use
- Exclusions: Severe heart failure, LVEF < 35%, stroke in previous 3 months, type 2 MI, recent or planned CABG, recent noncutaneous cancer, inflammatory bowel disease, nontransient creatine kinase elevation, hematologic or severe renal/hepatic disease, substance abuse, long-term systemic glucocorticoid therapy, sensitivity to colchicine

Interventions

- Randomly assigned to receive colchicine (0.5 mg once daily) or placebo

Outcomes

- Primary outcome occurred in 5.5% (colchicine) compared with 7.1% (placebo) (HR 0.77; 95% CI 0.61-0.96; P=0.02)
- Stroke (HR 0.26; 95% CI 0.10-0.70)
- Urgent hospitalization for angina leading to coronary revascularization (HR 0.50; 95% CI 0.31-0.81)
- Diarrhea reported in 9.7% (colchicine) vs 8.9% (placebo) (P=0.35)
- Pneumonia as a serious adverse event in 0.9% (colchicine) vs 0.4% (placebo) (P=0.03)

Criticisms

- The trial's follow-up duration was relatively short (~23 months), limiting assessment of long-term treatment with colchicine.
- Risks and benefits of prolonged colchicine therapy were not established.
- Results apply only to patients with recent myocardial infarction and may not generalize to other patient groups.

Funding

Supported by the Government of Quebec, the Canadian Institutes of Health Research, philanthropic foundations, with the funds administered by the Montreal Heart Institute.