Rationale and design of the COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 trial): A randomized, placebo-controlled, multicenter study on the use of colchicine for the primary prevention of the postpericardiotomy syndrome, postoperative effusions, and postoperative atrial fibrillation

• Published in: The American heart journal Vol. 166; no. 1; pp. 13 - 19.e1
• Main Authors: Imazio, Massimo, Belli, Riccardo, Brucato, Antonio, Ferrazzi, Paolo, Patrini, Davide, Martinelli, Luigi, Polizzi, Vincenzo, Cemin, Roberto, Leggieri, Anna, Caforio, Alida L.P., Finkelstein, Yaron, Hoit, Brian, Maisch, Bernhard, Mayosi, Bongani M., Oh, Jae K., Ristic, Arsen D., Seferovic, Petar, Spodick, David H., Adler, Yehuda
• Format: Journal Article
• Language: English
• Published: United States Mosby, Inc 01.07.2013; Elsevier Limited
• Subjects: Aspirin; Atrial Fibrillation - etiology; Atrial Fibrillation - prevention & control; Cardiac arrhythmia; Cardiovascular; Cell adhesion & migration; Clinical trials; Colchicine - therapeutic use; Drug therapy; Fever; Heart surgery; Humans; Multicenter Studies as Topic - methods; Nonsteroidal anti-inflammatory drugs; Older people; Patients; Pericardial Effusion - etiology; Pericardial Effusion - prevention & control; Pericardiectomy - adverse effects; Postoperative Complications - etiology; Postoperative Complications - prevention & control; Primary Prevention - methods; Randomized Controlled Trials as Topic - methods; Syndrome; Tubulin Modulators - therapeutic use
• ISSN: 0002-8703; 1097-6744; 1097-6744
• DOI: 10.1016/j.ahj.2013.03.025

The 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. The 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. The 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.