Daily colchicine treatment may reduce the risk for cardiovascular events in patients with chronic coronary disease, according to the results of a randomized, controlled, double-blind trial published in The New England Journal of Medicine.
Patients (n=6528; mean age, 66±8.6 years; 15.3% women) were recruited between 2014 and 2018 at 13 centers affiliated with Sir Charles Gairdner Hospital in Australia and 30 centers affiliated with the Dutch Network for Cardiovascular Research in the Netherlands. Participants had evidence of coronary disease in stable condition for at least 6 months prior to inclusion.
All patients were enrolled for a 1-month open-label trial of 0.5 mg of daily colchicine, of whom those who were in stable condition at 1 month (n=5522) were randomly assigned to receive daily colchicine (0.5 mg; n=2762) or placebo (n=2760). Participants were evaluated every 6 months until study conclusion (median follow-up, 28.6 months; interquartile range [IQR], 20.5-44.4 months; 10.5% early termination in each group).
At baseline, 18.2% of participants had diabetes, 99.7% were on antiplatelet or anticoagulant therapy, 71.7% were treated with renin-angiotensin inhibitors, and 62.1% with beta-blockers. Of the 5522 patients in the randomization phase of the study, 5478 received ≥1 dose of treatment.
At the end of the study, cardiac events (eg, cardiovascular death, myocardial infarction, ischemic stroke, or coronary revascularization) occurred in 6.8% and 9.6% of patients treated with colchicine and placebo, respectively (hazard ratio [HR], 0.69; 95% CI, 0.57-0.83; P <.001). Myocardial infarction or ischemia-driven coronary revascularization occurred in 5.6% and 8.1% of participants treated with colchicine and placebo, respectively (HR, 0.72; 95% CI, 0.57-0.92; P =.007).
The number of fatalities was comparable in the treatment (n=73) and placebo (n=60) groups (HR, 1.21; 95% CI, 0.86-1.71). However, a greater number of noncardiovascular-related deaths occurred in participants treated with colchicine (0.7 events per 100 person-years) vs placebo (0.5 events per 100 person-years).
Participants receiving colchicine and placebo had comparable rates of: new-onset atrial fibrillation (4.6% vs 5.4%, respectively), deep-venous thrombosis or pulmonary embolism (0.6% vs 0.6%, respectively), new-onset diabetes (1.2% vs 1.8%, respectively), cancer diagnoses (4.3% vs 4.4%, respectively), and hospitalization for infections (5.0% vs 5.2%, respectively), pneumonia (1.7% vs 2.0%, respectively), or gastrointestinal symptoms (1.9% vs 1.8%, respectively).
This study was limited by a lower proportion of women in the trial vs the general population and the fact that several clinical markers (eg, lipid levels, blood pressure) were not recorded at baseline.
“Among patients with chronic coronary disease, most of whom were already receiving proven secondary prevention therapies, 0.5 mg of colchicine once daily resulted in a 31% lower relative risk of cardiovascular death, spontaneous myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization (the primary end point) than placebo, with a hazard ratio of 0.69,” concluded the study authors.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Nidorf S M, Fiolet A T L, Mosterd A, et al. Colchicine in patients with chronic coronary disease. [published online August 31, 2020] N Engl J Med. doi:10.1056/NEJMoa2021372