Rationale and design of the colchicine for the prevention of perioperative atrial fibrillation in patients undergoing major noncardiac thoracic surgery (COP-AF) trial.
Atrial fibrillation
Colchicine
Inflammation
Myocardial injury
Prevention
Thoracic surgery
Journal
American heart journal
ISSN: 1097-6744
Titre abrégé: Am Heart J
Pays: United States
ID NLM: 0370465
Informations de publication
Date de publication:
05 2023
05 2023
Historique:
received:
04
11
2022
revised:
23
01
2023
accepted:
26
01
2023
medline:
11
4
2023
pubmed:
9
2
2023
entrez:
8
2
2023
Statut:
ppublish
Résumé
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. 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. 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.
Sections du résumé
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.
Identifiants
pubmed: 36754105
pii: S0002-8703(23)00025-X
doi: 10.1016/j.ahj.2023.01.018
pii:
doi:
Substances chimiques
Colchicine
SML2Y3J35T
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
87-96Subventions
Organisme : CIHR
ID : PJT-162458
Pays : Canada
Organisme : CIHR
ID : PJT-165842
Pays : Canada
Investigateurs
None Devereaux
Jessica Vincent
(J)
Michael Ke Wang
(MK)
Jennifer R Wells
(JR)
David Conen
(D)
P J Devereaux
(PJ)
Jeff S Healey
(JS)
Giovanni Landoni
(G)
William F McIntyre
(WF)
Ekaterine Popova
(E)
Daniel I Sessler
(DI)
Sadeesh K Srinathan
(SK)
Jessica Vincent
(J)
Michael Ke Wang
(MK)
Jennifer R Wells
(JR)
P J Devereaux
(PJ)
Mohammed Amir
(M)
Shrikant I Bangdiwala
(SI)
Matthias Bossard
(M)
Matthew T V Chan
(MTV)
John W Eikelboom
(JW)
Edith Fleischmann
(E)
Jeff S Healey
(JS)
Sanjit S Jolly
(SS)
Giovanni Landoni
(G)
William F McIntyre
(WF)
Felix Ramón Montes
(FR)
Ekaterine Popova
(E)
Cara Reimer
(C)
Denis Schmartz
(D)
Daniel I Sessler
(DI)
Sadeesh K Srinathan
(SK)
Jessica Vincent
(J)
Chew Yin Wang
(CY)
Michael Ke Wang
(MK)
Jennifer R Wells
(JR)
William F McIntyre
(WF)
Jesus Alvarez-Garcia
(J)
Giuliana Lo Bianco
(GL)
Steffen Blum
(S)
Danielle de Sa Boasquevisque
(DS)
Flavia K Borges
(FK)
Helene Chiarella-Redfern
(H)
Aranzazu Gonzalez-Osuna
(A)
Jose M Guerra-Ramos
(JM)
Maura Marcucci
(M)
Pascal B Meyre
(PB)
Sandra N Ofori
(SN)
Christopher Oleynick
(C)
Anna Ramos-Pachón
(A)
Hugh Traquair
(H)
Michael Ke Wang
(MK)
L Brent Mitchell
(LB)
George Wyse
(G)
Davy Cheng
(D)
Finlay A McAlister
(FA)
George A Wells
(GA)
Geethan Baskaran
(G)
Julia Gennaccaro
(J)
Rosemary Howe
(R)
Louise Mastrangelo
(L)
Shirley Pettit
(S)
Subana Shahbaz
(S)
Makayla Tosh
(M)
Jessica Vincent
(J)
Jennifer R Wells
(JR)
Simona J Zucchetto
(SJ)
Shrikant I Bangdiwala
(SI)
Laura Heenan
(L)
Shun Fu Lee
(SF)
Zhuoru Li
(Z)
Lizhen Xu
(L)
Mohammed Amir
(M)
Matthias Bossard
(M)
Matthew T V Chan
(MTV)
Edith Fleischmann
(E)
Giovanni Landoni
(G)
Felix Ramón Montes
(FR)
Ekaterine Popova
(E)
Denis Schmartz
(D)
Daniel I Sessler
(DI)
Chew Yin Wang
(CY)
Barbara Kabon
(B)
Edith Fleischmann
(E)
Christian Reiterer
(C)
Alexander Taschner
(A)
Katharina Horvath
(K)
Nikolas Adamowitsch
(N)
Oliver Zotti
(O)
Nicole Hantáková
(N)
Beatrix Hochreiter
(B)
Denis Schmartz
(D)
Isabelle Huybrechts
(I)
Serge Cappeliez
(S)
John D Neary
(JD)
Yaron Shargall
(Y)
Vikas Tandon
(V)
Christian Finley
(C)
John Agzarian
(J)
Waël Hanna
(W)
Muammar Abdulrahman
(M)
Kelly Lawrence
(K)
Krysten Gregus
(K)
Faraaz Quraishi
(F)
Spencer Wikkerink
(S)
Christine Wallace
(C)
Merissa Prine
(M)
Emily Gregus
(E)
Jacqueline Hare
(J)
Kristen Lombardo
(K)
Behashta Fezia
(B)
Teresa Columbus
(T)
Cara Reimer
(C)
Deborah DuMerton
(D)
Ken Reid
(K)
Joel Parlow
(J)
Wiley Chung
(W)
Maria Karizhenskaia
(M)
Aftab Malik
(A)
Sadeesh K Srinathan
(SK)
Biniam Kidane
(B)
Richard Liu
(R)
Lawrence Tan
(L)
Stephen Gowing
(S)
Gordon Buduhan
(G)
Stephanie Enns
(S)
Emma Poole
(E)
Kristin Graham
(K)
Sean R McLean
(SR)
Anna McGuire
(A)
Jens Lohser
(J)
Shirley Lim
(S)
Rebecca Grey
(R)
Kyle Grant
(K)
Alex L Lee
(AL)
James J Choi
(JJ)
Leith R Dewar
(LR)
John Yee
(J)
Donna E Maziak
(DE)
Andrew J E Seely
(AJE)
Sebastien Gilbert
(S)
P James Villeneuve
(PJ)
Sudhir Sundaresan
(S)
Susan D Moffatt-Bruce
(SD)
Molly Gingrich
(M)
Anna Fazekas
(A)
Kirby Bucciero
(K)
Richard A Malthaner
(RA)
Deb Lewis
(D)
Dalilah Fortin
(D)
Mehdi Qiabi
(M)
Rahul Nayak
(R)
Madelaine Marie Plourde
(MM)
Daniel Sellers
(D)
Laura Donahoe
(L)
Marco Lefebvre
(M)
Luc Lanthier
(L)
Colin Schieman
(C)
Amal Bessissow
(A)
Matthew T V Chan
(MTV)
Gavin M Joynt
(GM)
Randolph H L Wong
(RHL)
Rainbow W H Lau
(RWH)
Wai Tat Wong
(WT)
Gordon Y S Choi
(GYS)
Eva Lee
(E)
Ka Yan Hui
(KY)
Beaker Fung
(B)
Chee Sam Chan
(CS)
Laura Gutiérrez-Soriano
(L)
Felix Ramón Montes
(FR)
Laura Carmenza Castañeda
(LC)
Luis Jaime Téllez
(LJ)
Lina Marcela Ortiz-Ramirez
(LM)
Giovanni Landoni
(G)
Simona De Santis
(S)
Giovanni Favaro
(G)
Piergiorgio Muriana
(P)
Cristina Nakhnoukh
(C)
Pierluigi Novellis
(P)
Stefano Turi
(S)
Giulia Veronesi
(G)
Matteo Angelini
(M)
Luca Voltolini
(L)
Stefano Bongiolatti
(S)
Alberto Salvicchi
(A)
Lavinia Gatteschi
(L)
Rossella Indino
(R)
Simone Tombelli
(S)
Alice Ravasin
(A)
Ottavia Salimbene
(O)
Giulio Luca Rosboch
(GL)
Eleonora Balzani
(E)
Domenico Massullo
(D)
Silvia Fiorelli
(S)
Francesco Londero
(F)
William Grossi
(W)
Chew Yin Wang
(CY)
Tyng Yan Ng
(TY)
Woan Shiang See
(WS)
Mohammed Amir
(M)
Mohammed Asghar Nawaz
(MA)
Juan Carlos Trujillo Reyes
(JCT)
Ekaterine Popova
(E)
Elisabeth Martinez Tellez
(EM)
Josep Belda Sanchis
(JB)
Georgina Planas Cánovas
(GP)
Ana Parera Ruiz
(AP)
Esther Cladellas Gutierrez
(EC)
Mauro Guarino
(M)
Gerard Urrutia Cuchi
(GU)
Marta Argilaga Nogues
(MA)
Anna Rovira Juan
(AR)
Jose M Guerra-Ramos
(JM)
Jesus Alvarez-Garcia
(J)
Aranzazu Gonzalez-Osuna
(A)
Melixa Medina-Aedo
(M)
Ascensión Martín Grande
(AM)
Diego Parise Roux
(DP)
Luis Gajate Martín
(LG)
Angélica De Pablo Pajares
(AP)
Angel Manuel Candela Toha
(AMC)
Nicolás Moreno Mata
(NM)
Gema Muñoz Molina
(GM)
Usue Caballero Silva
(UC)
Alberto Cabañero
(A)
Sara Fra Fernandez
(SF)
Anna Gonzàlez Tallada
(AG)
Susana González Suarez
(SG)
Montserrat Ribas Ball
(MR)
Miriam De Nadal Clanchet
(MN)
Laura Ruiz-Villa
(L)
M M Martí-Ejarque
(MM)
Mireia Gili-Bueno
(M)
Jorge Hernández Ferrández
(JH)
Neus Pons Llobet
(NP)
Patricia Cruz
(P)
Guillermo Sánchez-Pedrosa
(G)
Patricia Duque
(P)
Leire Azcárate
(L)
Lorena Martín-Albo
(L)
Alberto Rodríguez-Fuster
(A)
Silvia Bermejo-Martínez
(S)
Albert Carramiñana
(A)
Matthias Bossard
(M)
Fabrizio Minervini
(F)
Juan P Cata
(JP)
Ravi Rajaram
(R)
German Corrales
(G)
Juan Jose Guerra-Londono
(JJ)
Reza Mehran
(R)
Boris Sepesi
(B)
Garrett Walsh
(G)
Daniel S Cukierman
(DS)
Bryan E Marchant
(BE)
Lynne C Harris
(LC)
Bruce D Cusson
(BD)
Scott A Miller
(SA)
Steven C Minear
(SC)
Camila Teixeira
(C)
Mario Pimentel
(M)
Andrew M Popoff
(AM)
Wing Lee Cheung
(WL)
Kelly Marsack
(K)
Sabry Ayad
(S)
Jorge Araujo
(J)
Tzonghuei H Chen
(TH)
Michael Essandoh
(M)
Jeremy S Poppers
(JS)
Informations de copyright
Copyright © 2023 Elsevier Inc. All rights reserved.