Low-dose colchicine (LoDoCo, Agepha Pharma) was recently approved by the U.S. Food and Drug Administration to reduce the risk for MI, stroke, coronary revascularization, or death in patients with established atherosclerotic disease or multiple risk factors for cardiovascular disease (the LoDoCo trials and the COLCOT trial).
COP-AF trial evaluated the effect of low-dose colchicine on the occurrence of perioperative atrial fibrillation and myocardial injury (MINS) after major non-cardiac thoracic surgery.
Results of the COP-AF trial were presented at the European Society of Cardiology (ESC) Congress 2023 in Amsterdam, the Netherlands, and published online August 25 in The Lancet.
COP-AF was a randomized trial, conducted at 45 sites in 11 countries, and enrolled 3209 patients (mean age 68 years [SD 7], 1656 [51,6%] male) undergoing major noncardiac thoracic surgery. Patients were excluded if they had previous AF, had any contraindications to colchicine, or required colchicine on a clinical basis.
Patients were randomly assigned 1:1 to receive oral colchicine at a dose of 0.5 mg twice daily (1608 patients) or placebo (1601 patients). Treatment was begun within 4 hours before surgery and continued for 10 days. Healthcare providers and patients, as well as data collectors and adjudicators, were blinded to treatment assignment.
Clinically important atrial fibrillation occurred in 103 (6,4%) of 1608 patients assigned to colchicine, and 120 (7,5%) of 1601 patients assigned to placebo (hazard ratio [HR] 0,85, 95% CI 0,65 to 1,10; absolute risk reduction [ARR] 1,1%, 95% CI –0,7 to 2,8; p=0,22). MINS occurred in 295 (18,3%) patients assigned to colchicine and 325 (20,3%) patients assigned to placebo (HR 0,89, 0,76 to 1,05; ARR 2,0%, –0,8 to 4,7; p=0,16). The composite outcome of sepsis or infection occurred in 103 (6,4%) patients in the colchicine group and 83 (5,2%) patients in the placebo group (HR 1,24, 0,93–1,66). Non-infectious diarrhoea was more common in the colchicine group (134 [8,3%] events) than the placebo group (38 [2,4%]; HR 3,64, 2,54–5,22).
In patients undergoing major non-cardiac thoracic surgery, administration of colchicine did not significantly reduce the incidence of clinically important atrial fibrillation or MINS but increased the risk of mostly benign non-infectious diarrhoea.