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"Colchicine in Patients with Chronic Coronary Disease".The New England Journal of Medicine. 2020.

Clinical Question

Does colchicine reduce the risk of cardiovascular events in patients with chronic coronary disease?

Bottom Line

Colchicine at a dose of 0.5 mg once daily reduced the risk of cardiovascular events in patients with chronic coronary disease when compared to placebo.

Major Points

Guidelines

Current guidelines do not include recommendations on the use of colchicine for chronic coronary disease (as of the knowledge cutoff date).

Design

- Multicenter, randomized, controlled, double-blind, event-driven trial.
- N=5,552.
- Colchicine 0.5mg once daily (n=2,762).
- Placebo (n=2,760).
- Enrollment: 2014-2018

Population

- Adults aged 35-82 years with evidence of chronic coronary disease.
- Exclusion criteria included moderate-to-severe renal impairment, severe heart failure, severe valvular heart disease, or known adverse effects from colchicine.

Interventions

- Colchicine 0.5 mg once daily or matching placebo after a 1-month open-label run-in period.

Outcomes

- Primary: A composite of cardiovascular death, spontaneous myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization.
- Secondary: A composite of cardiovascular death, spontaneous myocardial infarction, or ischemic stroke.
- Other outcomes: Spontaneous myocardial infarction or ischemia-driven coronary revascularization and others.

Criticisms

- The trial population included a lower percentage of women than expected based on the prevalence of chronic coronary disease in the general population.
- Blood pressure and lipid levels were not collected at baseline or during the trial; therefore, outcomes according to risk-factor control could not be reported.
- There was no routine measurement of C-reactive protein or other inflammatory markers.
- The difference in noncardiovascular death rates between groups was not statistically significant but could be a potential concern.

Funding

- The National Health Medical Research Council of Australia and several other agencies and organizations.