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

The COP-AF Investigators

doi:10.1016/j.ahj.2023.01.018

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

The COP-AF Investigators

Anesthesiology

Population Health Research Institute, Ontario
McMaster University
Research Institute of the Santa Creu i Sant Pau Hospital
Iberoamerican Cochrane Centre
Hospital de La Santa Creu I Sant Pau
Chinese University of Hong Kong
San Raffaele Scientific Institute
Vita-Salute San Raffaele University
Kingston Health Sciences Centre
University of Manitoba
Winnipeg Regional Health Authority
University of Texas MD Anderson Cancer Center
University of British Columbia
Vancouver General Hospital
Hospital Ramon y Cajal
University Hospital Vall d'Hebron
Cleveland Clinic Foundation
Medical University of Vienna
University of Ottawa
Azienda Ospedaliera Careggi
Fundación Cardioinfantil - Instituto de Cardiología
University of Basel
University of Port Harcourt
Western University
Brugmann University Hospital
Université libre de Bruxelles
University Hospital of Charlero

Research output: Contribution to journal › Article › peer-review

4 Scopus citations

Abstract

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.

Original language	English
Pages (from-to)	87-96
Number of pages	10
Journal	American Heart Journal
Volume	259
DOIs	https://doi.org/10.1016/j.ahj.2023.01.018
State	Published - May 2023

Keywords

Atrial fibrillation
Colchicine
Inflammation
Myocardial injury
Prevention
Thoracic surgery

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10.1016/j.ahj.2023.01.018

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@article{61e86608ada34bf188a69a5b5c1575af,

title = "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",

abstract = "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 {\textquoteleft}COlchicine for the Prevention of Perioperative Atrial Fibrillation{\textquoteright} (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.",

keywords = "Atrial fibrillation, Colchicine, Inflammation, Myocardial injury, Prevention, Thoracic surgery",

author = "\{The COP-AF Investigators\} and David Conen and Ekaterine Popova and Wang, \{Michael Ke\} and Chan, \{Matthew T.V.\} and Giovanni Landoni and Cara Reimer and Srinathan, \{Sadeesh K.\} and Cata, \{Juan P.\} and McLean, \{Sean R.\} and Reyes, \{Juan Carlos Trujillo\} and Grande, \{Ascensi{\'o}n Mart{\'i}n\} and Tallada, \{Anna Gonzalez\} and Sessler, \{Daniel I.\} and Edith Fleischmann and Maziak, \{Donna E.\} and Barbara Kabon and Luca Voltolini and Laura Guti{\'e}rrez-Soriano and Vikas Tandon and Deborah DuMerton and Biniam Kidane and Ravi Rajaram and Yaron Shargall and Neary, \{John D.\} and Wells, \{Jennifer R.\} and McIntyre, \{William F.\} and Steffen Blum and Ofori, \{Sandra N.\} and Jessica Vincent and Lizhen Xu and Zhuoru Li and Healey, \{Jeff S.\} and Garg, \{Amit X.\} and Devereaux, \{P. J.\} and Christian Reiterer and Alexander Taschner and Katharina Horvath and Nikolas Adamowitsch and Oliver Zotti and Nicole Hant{\'a}kov{\'a} and Beatrix Hochreiter and Denis Schmartz and Isabelle Huybrechts and Serge Cappeliez and Christian Finley and John Agzarian and Wa{\"e}l Hanna and Muammar Abdulrahman and Kelly Lawrence and Poppers, \{Jeremy S.\}",

note = "Publisher Copyright: {\textcopyright} 2023 Elsevier Inc.",

year = "2023",

month = may,

doi = "10.1016/j.ahj.2023.01.018",

language = "English",

volume = "259",

pages = "87--96",

journal = "American Heart Journal",

issn = "0002-8703",

}

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 - Hanna, Waël

AU - Abdulrahman, Muammar

AU - Lawrence, Kelly

AU - Poppers, Jeremy S.

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

UR - https://www.scopus.com/pages/publications/85151233458

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 -

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

Abstract

Keywords

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