Dr. Massimo Imazio,
Dr. Konstantinos C. Koskinas
By Massimo Imazio, FESC (Torino, Italy)View Discussant reportRead the press releaseOpen the PresentationWatch the WebcastESC TV: Watch Dr. Massimo Imazio's interview
List of Authors: Massimo Imazio, MD,1; Antonio Brucato, MD,2; Paolo Ferrazzi, MD,2; Alberto Pullara, MD,1; Yehuda Adler, MD,3; Alberto Barosi, MD,4; Alida L Caforio, MD,5; Roberto Cemin, MD,6; Fabio Chirillo, MD,7; Chiara Comoglio, MD,8; Diego Cugola, MD,2; Davide Cumetti, MD,2; Oleksandr Dyrda, MD,8; Stefania Ferrua, MD,9; Yaron Finkelstein, MD,10; Roberto Flocco, MD,11; Anna Gandino, MD,4; Brian Hoit, MD,12; Francesco Innocente, MD,2; Silvia Maestroni, MD,2; Francesco Musumeci, MD,13; Jae Oh, MD,14; Amedeo Pergolini, MD,13; Vincenzo Polizzi, MD,13; Arsen Ristic, MD,15; Caterina Simon, MD,2; David H Spodick, MD,16; Vincenzo Tarzia, MD, 5; Stefania Trimboli, MD,8; Anna Valenti, MD,2; Riccardo Belli, MD,1; and Fiorenzo Gaita, MD,17; for the COPPS-2 Investigators.
1-Cardiology Department, Maria Vittoria Hospital, ASLTO2, and University of Torino, Torino, Italy.2-Internal Medicine Department, Ospedale Papa Giovanni XXIII, Bergamo, Italy.3-Chaim Sheba Medical Center, Tel Hashomer and Sacker University, Tel Aviv, Israel.4-Internal Medicine and Cardiac Surgery, Ospedale Niguarda, Milano, Italy.5Department of Cardiological Thoracic and Vascular Sciences, University of Padova, Italy.6-Cardiology Department, Ospedale Regionale San Maurizio, Bolzano, Italy.7-Cardiology and Cardiac Surgery Department, Ca Foncello Hospital, Treviso, Italy.8-Cardiac Surgery and Rehabilitation, Villa Maria Pia Hospital, Torino, Italy.9-Cardiology Department, Ospedale degli Infermi, Rivoli, Italy-10-Department of Pediatrics, Hospital for Sick Children, Toronto, Ontario, Canada.11-Cardiac Surgery, Ospedale Mauriziano, Torino, Italy.12-Case Western Reserve University, Cleveland, Ohio; and the University Hospitals Case Medical Center, Cleveland, Ohio, USA.13-Cardiac Surgery, Ospedale San Camillo, Roma, Italy.14-Division of Cardiovascular Disease, Mayo Clinic, Rochester, MN, USA.15-Department of Cardiology, Belgrade University School of Medicine and Clinical Centre of Serbia, Belgrade, Serbia.16-St Vincent Hospital, Worcester, Massachusetts, USA.17-University Cardiology Department, Ospedale Maggiore San Giovanni Battista della Città di Torino and University of Torino, Torino, Italy.
ImportancePost-pericardiotomy syndrome, post-operative atrial fibrillation (AF), and post-operative effusions may be responsible for increased morbidity and healthcare costs after cardiac surgery. Postoperative use of colchicine prevented these complications in a single trial.ObjectiveTo determine whether perioperative use of oral colchicine is safe and reduces these complications. Design, Setting, and ParticipantsThe Colchicine for Prevention of the Post-pericardiotomy Syndrome and post-operative atrial fibrillation (COPPS-2 trial) is an investigator-initiated, double-blind, placebo-controlled, randomized clinical trial. A total of 360 consecutive candidates for cardiac surgery, 180 for each arm, were enrolled in 11 Italian centers between March 2012 and March 2014. Main exclusion criteria were absence of sinus rhythm at enrollment, cardiac transplantation, and contraindications to colchicine.InterventionPatients were randomized to receive placebo or colchicine (0.5 mg twice daily in patients ≥70 kg or 0.5 mg once daily in patients <70kg) between 48-72 hours before surgery and continued for 1 month after surgery.Main Outcome MeasureOccurrence of post-pericardiotomy syndrome within 3 months. Main secondary study end points were postoperative AF and effusions. ResultsAt enrollment, mean age of the trial participants was 67.5±10.6 years, 69% were men, and 36% had planned valvular surgery. The primary end point occurred in 35 (19.4%) patients assigned to colchicine and in 53 (29.4%) assigned to placebo (absolute difference 10.0% 95%CI 1.1-18.7%, NNT=10). None of the secondary end points were significantly different between placebo and colchicine, except for a post-operative AF which was recorded in 61 (41.2%) patients assigned to placebo and 38 (27.0%) assigned to colchicine (absolute difference 14.3% 95%CI 3.3-24.7, NNT=7) at the pre-specified on-treatment analysis. Adverse events occurred in 21 (11.7%) patients for placebo group vs. 36 (20.0%) for colchicine (absolute difference 8.3% 95%CI 0.76-15.9%, NNH=12), but discontinuation rates were similar. No serious adverse events were observed.Conclusions and RelevanceAmong patients undergoing cardiac surgery, the perioperative use of colchicine compared with placebo reduced the incidence of post-pericardiotomy syndrome but not of post-operative AF or postoperative effusions. The increased risk of gastrointestinal adverse effects reduced the potential benefits of colchicine in this setting.Trial Registration ClinicalTrials.gov Identifier: NCT01552187Accepted by JAMA for contemporary online presentation
By Stavros V Konstantinides, FESC (Mainz, Germany)Open the presentationWatch the Webcast
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