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American heart journal · Sep 2011
Randomized Controlled Trial Multicenter Study Comparative StudyColchicine prevents early postoperative pericardial and pleural effusions.
- Massimo Imazio, Antonio Brucato, Maria Elena Rovere, Anna Gandino, Roberto Cemin, Stefania Ferrua, Silvia Maestroni, Edoardo Zingarelli, Alberto Barosi, Caterina Simon, Fabrizio Sansone, Davide Patrini, Ettore Vitali, Riccardo Belli, Paolo Ferrazzi, Rita Trinchero, David H Spodick, and Yehuda Adler.
- Cardiology Department, Maria Vittoria Hospital, Torino, Italy. massimo_imazio@yahoo.it
- Am. Heart J. 2011 Sep 1; 162 (3): 527-32.e1.
BackgroundNo preventive pharmacologic strategies have been proven efficacious for the prevention of postoperative effusions after cardiac surgery. Colchicine is safe and efficacious for the prevention of pericarditis. On this basis, we realized a substudy of the COPPS trial to assess the efficacy and safety of colchicine for the prevention of postoperative pericardial and pleural effusions.MethodsThe COPPS is a multicenter, double-blind, randomized trial, where 360 consecutive patients (mean age 65.7 ± 12.3 years, 66% men), 180 in each treatment arm, were randomized on the third postoperative day to receive placebo or colchicine for 1 month (1.0 mg twice daily for the first day, followed by a maintenance dose of 0.5 mg twice daily in patients ≥70 kg, and halved doses for patients <70 kg). The incidence of postoperative effusions was evaluated in each study group.ResultsDespite similar baseline features, colchicine significantly reduced the incidence of postoperative pericardial (12.8% vs 22.8%, P = .019, relative risk reduction 43.9%, no. of patients needed to treat 10) and pleural effusions (12.2% vs 25.6%, P = .002, relative risk reduction 52.3%, no. of patients needed to treat 8). The rate of side effects (only gastrointestinal intolerance) and drug withdrawal was similar in the study groups with a trend toward an increased rate of both events for colchicine. In multivariable analysis, female gender (hazard ratio 1.76, 95% CI 1.03-3.03, P = .040) and pleura incision (hazard ratio 2.58, 95% CI 1.53-4.53, P < .001) were risk factors for postoperative effusions.ConclusionsColchicine is safe and efficacious for the primary prevention of postoperative effusions after cardiac surgery.Copyright © 2011 Mosby, Inc. All rights reserved.
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