• Massimo Imazio, Riccardo Belli, Antonio Brucato, Paolo Ferrazzi, Davide Patrini, Luigi Martinelli, Vincenzo Polizzi, Roberto Cemin, Anna Leggieri, Alida L P Caforio, Yaron Finkelstein, Brian Hoit, Bernhard Maisch, Bongani M Mayosi, Jae K Oh, Arsen D Ristic, Petar Seferovic, David H Spodick, and Yehuda Adler.
• Cardiology Department and Pharmacology Unit, Maria Vittoria Hospital, Torino, Italy. massimo_imazio@yahoo.it
• Am. Heart J. 2013 Jul 1; 166 (1): 13-9.

BackgroundThe efficacy and safety of colchicine for the primary prevention of the postpericardiotomy syndrome (PPS), postoperative effusions, and postoperative atrial fibrillation (POAF) remain uncertain. Although preliminary data from a single trial of colchicine given for 1 month postoperatively (COPPS trial) were promising, the results have not been confirmed in a large, multicenter trial. Moreover, in the COPPS trial, colchicine was given 3 days postoperatively.MethodsThe COPPS-2 study is a multicenter, double-blind, placebo-controlled randomized trial. Forty-eight to 72 hours before planned cardiac surgery, 360 patients, 180 in each treatment arm, will be randomized to receive placebo or colchicine without a loading dose (0.5 mg twice a day for 1 month in patients weighing ≥70 kg and 0.5 mg once for patients weighing <70 kg or intolerant to the highest dose). The primary efficacy end point is the incidence of PPS, postoperative effusions, and POAF at 3 months after surgery. Secondary end points are the incidence of cardiac tamponade or need for pericardiocentesis or thoracentesis, PPS recurrence, disease-related admissions, stroke, and overall mortality.ConclusionsThe COPPS-2 trial will evaluate the use of colchicine for the primary prevention of PPS, postoperative effusions, and POAF, potentially providing stronger evidence to support the use of preoperative colchicine without a loading dose to prevent several postoperative complications. ClinicalTrials.gov Identifier: NCT01552187.Copyright © 2013 Mosby, Inc. All rights reserved.

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