TY - JOUR
T1 - Rationale and design of the colchicine for the prevention of perioperative atrial fibrillation in patients undergoing major noncardiac thoracic noncardiac thoracic surgery (COP-AF) trial
AU - The COP-AF Investigators
AU - Conen, David
AU - Popova, Ekaterine
AU - Wang, Michael Ke
AU - Chan, Matthew T.V.
AU - Landoni, Giovanni
AU - Reimer, Cara
AU - Srinathan, Sadeesh K.
AU - Cata, Juan P.
AU - McLean, Sean R.
AU - Reyes, Juan Carlos Trujillo
AU - Grande, Ascensión Martín
AU - Tallada, Anna Gonzalez
AU - Sessler, Daniel I.
AU - Fleischmann, Edith
AU - Maziak, Donna E.
AU - Kabon, Barbara
AU - Voltolini, Luca
AU - Gutiérrez-Soriano, Laura
AU - Tandon, Vikas
AU - DuMerton, Deborah
AU - Kidane, Biniam
AU - Rajaram, Ravi
AU - Shargall, Yaron
AU - Neary, John D.
AU - Wells, Jennifer R.
AU - McIntyre, William F.
AU - Blum, Steffen
AU - Ofori, Sandra N.
AU - Vincent, Jessica
AU - Xu, Lizhen
AU - Li, Zhuoru
AU - Healey, Jeff S.
AU - Garg, Amit X.
AU - Devereaux, P. J.
AU - Reiterer, Christian
AU - Taschner, Alexander
AU - Horvath, Katharina
AU - Adamowitsch, Nikolas
AU - Zotti, Oliver
AU - Hantáková, Nicole
AU - Hochreiter, Beatrix
AU - Schmartz, Denis
AU - Huybrechts, Isabelle
AU - Cappeliez, Serge
AU - Finley, Christian
AU - Agzarian, John
AU - Mehran, Reza
AU - Sepesi, Boris
AU - Walsh, Garrett
AU - Rice, David
N1 - Publisher Copyright:
© 2023 Elsevier Inc.
PY - 2023/5
Y1 - 2023/5
N2 - Background: Perioperative atrial fibrillation (AF) and myocardial injury after noncardiac surgery (MINS) are common complications after noncardiac surgery. Inflammation has been implicated in the pathogenesis of both disorders. The COP-AF trial tests the hypothesis that colchicine reduces the incidence of perioperative AF and MINS in patients undergoing major noncardiac thoracic surgery. Methods and Results: The ‘COlchicine for the Prevention of Perioperative Atrial Fibrillation’ (COP-AF) trial is an international, blinded, randomized trial that compares colchicine to placebo in patients aged at least 55 years and undergoing major noncardiac thoracic surgery with general anesthesia. Exclusion criteria include a history of AF and a contraindication to colchicine (eg, severe renal dysfunction). Oral colchicine at a dose of 0.5 mg or matching placebo is given within 4 hours before surgery. Thereafter, patients receive colchicine 0.5 mg or placebo twice daily for a total of 10 days. The 2 independent co-primary outcomes are clinically important perioperative AF (including atrial flutter) and MINS during 14 days of follow-up. The main safety outcomes are sepsis or infection and non-infectious diarrhea. We aim to enroll 3,200 patients from approximately 40 sites across 11 countries to have at least 80% power for the independent evaluation of the 2 co-primary outcomes. The COP-AF main results are expected in 2023. Conclusions: COP-AF is a large randomized and blinded trial designed to determine whether colchicine reduces the risk of perioperative AF or MINS in patients who have major noncardiac thoracic surgery.
AB - Background: Perioperative atrial fibrillation (AF) and myocardial injury after noncardiac surgery (MINS) are common complications after noncardiac surgery. Inflammation has been implicated in the pathogenesis of both disorders. The COP-AF trial tests the hypothesis that colchicine reduces the incidence of perioperative AF and MINS in patients undergoing major noncardiac thoracic surgery. Methods and Results: The ‘COlchicine for the Prevention of Perioperative Atrial Fibrillation’ (COP-AF) trial is an international, blinded, randomized trial that compares colchicine to placebo in patients aged at least 55 years and undergoing major noncardiac thoracic surgery with general anesthesia. Exclusion criteria include a history of AF and a contraindication to colchicine (eg, severe renal dysfunction). Oral colchicine at a dose of 0.5 mg or matching placebo is given within 4 hours before surgery. Thereafter, patients receive colchicine 0.5 mg or placebo twice daily for a total of 10 days. The 2 independent co-primary outcomes are clinically important perioperative AF (including atrial flutter) and MINS during 14 days of follow-up. The main safety outcomes are sepsis or infection and non-infectious diarrhea. We aim to enroll 3,200 patients from approximately 40 sites across 11 countries to have at least 80% power for the independent evaluation of the 2 co-primary outcomes. The COP-AF main results are expected in 2023. Conclusions: COP-AF is a large randomized and blinded trial designed to determine whether colchicine reduces the risk of perioperative AF or MINS in patients who have major noncardiac thoracic surgery.
KW - Atrial fibrillation
KW - Colchicine
KW - Inflammation
KW - Myocardial injury
KW - Prevention
KW - Thoracic surgery
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U2 - 10.1016/j.ahj.2023.01.018
DO - 10.1016/j.ahj.2023.01.018
M3 - Article
C2 - 36754105
AN - SCOPUS:85151233458
SN - 0002-8703
VL - 259
SP - 87
EP - 96
JO - American Heart Journal
JF - American Heart Journal
ER -