Abstract 18395: Colchicine for the Prevention of the Post-Pericardiotomy Syndrome and Post-Operative Effusions Following Cardiac Surgery. Results of a Multicenter, Double-Blind, Placebo-Controlled Randomized Trial.
Background: At present, no preventive pharmacological strategies (either NSAID or corticosteroids) have been proven efficacious for the prevention of the post-pericardiotomy syndrome (PPS). Colchicine is safe and efficacious for the treatment and prevention of pericarditis. The COlchicine for the Prevention of the Post-pericardiotomy Syndrome (COPPS) trial is a multicenter, double-blind, placebo-controlled, randomized trial aimed at evaluating the efficacy and safety of colchicine for the primary prevention of the PPS.
Methods: On the 3rd post-operative day, 360 consecutive patients undergoing cardiac surgery were randomized to receive placebo or colchicine (1.0 mg twice daily for the first day followed by a maintenance dose of 0.5 mg twice daily for 1 month in patients ≥70 kg, and halved doses for patients <70 kg or intolerant to the highest dose). The primary study end point was the incidence of the PPS at 12 months. The secondary end point was the combined rate of disease-related hospitalization, cardiac tamponade, constrictive and recurrent pericarditis. Additional analyses evaluated the effects of colchicine on the incidence of post-operative pericardial and pleural effusions.
Results: Baseline patient characteristics were similar between the 2 study groups. Colchicine significantly reduced the incidence of the PPS at 12 months (respectively, 8.9% vs. 21.1%; p=0.002; relative risk reduction-RRR 57.9% 95% CI 27.3-75.6, number needed to treat-NNT 8) and the secondary endpoint (respectively 0.55% vs. 5.0%; p=0.024; RRR 88.9% 95% CI 13.2-98.6). Colchicine also reduced the incidence of postoperative pericardial (RRR 43.6% 95% CI 8.8-65.1; p=0.024;NNT 11) and pleural effusions (RRR 64.9% 95% CI 36.2-80.7; p<0.001;NNT 8). Side effects (only gastrointestinal intolerance) and drug withdrawals were similar in the colchicine and placebo groups (respectively 8.9% vs. 5.0%; p=0.212, and 11.7% vs. 6.7%; p=0.145) with a trend towards an increased rate of both events for colchicine.
Conclusions: Colchicine is safe and efficacious for the primary prevention of the PPS and its related complications and may halve the risk of developing the syndrome following cardiac surgery. (ClinicalTrials.gov number, NCT00128427).
- © 2010 by American Heart Association, Inc.