Effect of ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients: END-AF Trial.

ABSTRACT

BACKGROUND: Atrial fibrillation (AF) is a common arrhythmia in patients undergoing cardiac surgery and may result in significant morbidity and increased hospital stay. This study was conducted to determine if colchicine administered preoperatively to patients undergoing cardiac surgery and continued during hospitalization is effective in reducing the incidence of postoperative AF. METHODS: In this multicenter prospective randomized open-label study, consecutive patients with no history of AF and scheduled to undergo elective cardiac surgery (n = 360) were randomized to colchicine (n = 179) or no-colchicine (n = 181). Main exclusion criteria were history of AF or supraventricular arrhythmias or absence of sinus rhythm at enrolment, and contraindications to colchicine. Colchicine was orally administered 12 to 24 hours preoperatively and continued until hospital discharge. The primary efficacy end point was documented AF lasting more than 5 minutes. Safety end point was colchicine adverse effects. RESULTS: In-hospital mortality was 3.3%. The primary end point of AF occurred in 63 patients (17.5%) 26 (14.5%) in the colchicine group and 37 (20.5%) in the no-colchicine group (relative risk reduction 29.3% [P = .14]). Diarrhea occurred in 54 patients, 44 (24.6%) on colchicine and 10 (5.5%) on no-colchicine (P < .001). Diarrhea led to discontinuation of colchicine in 23 (52%) of the 44 patients. CONCLUSION: Colchicine administered preoperatively to patients undergoing cardiac surgery and continued until hospital discharge failed to significantly reduce the incidence of early postoperative AF. Diarrhea was the most common adverse effect of colchicine leading to its discontinuation in more than half of the patients with this adverse effect.