Rationale and design of the colchicine for the prevention of perioperative atrial fibrillation in patients undergoing major noncardiac thoracic surgery (COP-AF) trial

Conen D 1 , Popova E 2 , Wang MK 3 , Chan MTV 4 , Landoni G 5 , Reimer C 6 Show all authors , Srinathan SK 7 , Cata JP 8 , McLean SR 9 , Trujillo Reyes JC 10 , Grande AM 11 , Gonzalez Tallada A 12 , Sessler DI 13 , Fleischmann E 14 , Maziak DE 15 , Kabon B 14 , Voltolini L 16 , Gutiérrez-Soriano L 17 , Tandon V 18 , DuMerton D 6 , Kidane B 19 , Rajaram R 20 , Shargall Y 21 , Neary JD 18 , Wells JR 22 , McIntyre WF 3 , Blum S 23 , Ofori SN 24 , Vincent J 22 , Xu L 25 , Li Z 22 , Healey JS 25 , Garg AX 26 , Devereaux PJ 3 , COP-AF Investigators

Affiliations 

  • 1 Population Health Research Institute, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada. Electronic address: David.conen@phri.ca
  • 2 Biomedical Research Institute (IIB Sant Pau), Barcelona, Spain; Iberoamerican Cochrane Centre, Barcelona, Spain
  • 3 Population Health Research Institute, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada
  • 4 The Chinese University of Hong Kong, Shatin, Hong Kong Special Administrative Region, China
  • 5 Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy
  • 6 Kingston Health Sciences Centre, Kingston, Ontario, Canada
  • 7 Department of Surgery, University of Manitoba, Winnipeg, Manitoba , Canada
  • 8 Department of Anesthesiology and Perioperative Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX
  • 9 Department of Anesthesia, Vancouver Acute (Vancouver General Hospital and UBC Hospital), The University of British Columbia, Vancouver, British Columbia, Canada; Department of Anesthesia, Pharmacology and Therapeutics, The University of British Columbia, Vancouver, British Columbia, Canada
  • 10 Department of Thoracic Surgery, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
  • 11 Hospital Universitario Ramón y Cajal, Madrid, Spain
  • 12 Department of Anesthesiology, Hospital Universitari Vall d'Hebron, Barcelona, Spain
  • 13 Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH
  • 14 Department of Anesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria
  • 15 University of Ottawa, Ottawa, Ontario, Canada
  • 16 Thoracic Surgery Unit, Careggi University Hospital, Florence, Italy
  • 17 Department of Anesthesiology, Fundación CardioInfantil - Instituto de Cardiología, Bogotá, Colombia
  • 18 Department of Medicine, McMaster University, Hamilton, Ontario, Canada
  • 19 Departments of Surgery, Physiology and Pathophysiology, University of Manitoba, Winnipeg, Manitoba, Canada
  • 20 Department of Cardiothoracic Surgery, The University of Texas - MD Anderson Cancer Center, Houston, TX
  • 21 Division of Thoracic Surgery, Department of Surgery, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada
  • 22 Population Health Research Institute, Hamilton, Ontario, Canada
  • 23 Population Health Research Institute, Hamilton, Ontario, Canada; Cardiovascular Research Institute Basel, University Hospital Basel, Basel, Switzerland
  • 24 Population Health Research Institute, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada; University of Port Harcourt, Choba, Nigeria
  • 25 Population Health Research Institute, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada
  • 26 Population Health Research Institute, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Departments of Medicine, Epidemiology and Biostatistics, Western University, London, Ontario, Canada
Am Heart J, 2023 May;259:87-96.
PMID: 36754105 DOI: 10.1016/j.ahj.2023.01.018

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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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