• David Conen, Ke WangMichaelMPopulation Health Research Institute, Hamilton, ON, Canada; Department of Medicine, McMaster University, Hamilton, ON, Canada., Ekaterine Popova, ChanMatthew T VMTVThe Chinese University of Hong Kong, Shatin, Hong Kong Special Administrative Region, China., Giovanni Landoni, Juan P Cata, Cara Reimer, Sean R McLean, Sadeesh K Srinathan, Juan Carlos Trujillo Reyes, Ascension Martín Grande, Anna Gonzalez Tallada, Daniel I Sessler, Edith Fleischmann, Barbara Kabon, Luca Voltolini, Patrícia Cruz, Donna E Maziak, Laura Gutiérrez-Soriano, William F McIntyre, Vikas Tandon, Elisabeth Martínez-Téllez, Juan Jose Guerra-Londono, Deborah DuMerton, WongRandolph H LRHLDivision of Cardiothoracic Surgery, Department of Surgery, The Chinese University of Hong Kong, Hong Kong Special Administrative Region, China., Anna L McGuire, Biniam Kidane, Diego Parise Roux, Yaron Shargall, Jennifer R Wells, Sandra N Ofori, Jessica Vincent, Lizhen Xu, Zhuoru Li, John W Eikelboom, Sanjit S Jolly, Jeff S Healey, P J Devereaux, and COP-AF Investigators.
• Population Health Research Institute, Hamilton, ON, Canada; Department of Medicine, McMaster University, Hamilton, ON, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada. Electronic address: david.conen@phri.ca.
• Lancet. 2023 Nov 4; 402 (10413): 162716351627-1635.

BackgroundHigher levels of inflammatory biomarkers are associated with an increased risk of perioperative atrial fibrillation and myocardial injury after non-cardiac surgery (MINS). Colchicine is an anti-inflammatory drug that might reduce the incidence of these complications.MethodsCOP-AF was a randomised trial conducted at 45 sites in 11 countries. Patients aged 55 years or older and undergoing major non-cardiac thoracic surgery were randomly assigned (1:1) to receive oral colchicine 0·5 mg twice daily or matching placebo, starting within 4 h before surgery and continuing for 10 days. Randomisation was done with use of a computerised, web-based system, and was stratified by centre. Health-care providers, patients, data collectors, and adjudicators were masked to treatment assignment. The coprimary outcomes were clinically important perioperative atrial fibrillation and MINS during 14 days of follow-up. The main safety outcomes were a composite of sepsis or infection, and non-infectious diarrhoea. The intention-to-treat principle was used for all analyses. This trial is registered with ClinicalTrials.gov, NCT03310125.FindingsBetween Feb 14, 2018, and June 27, 2023, we enrolled 3209 patients (mean age 68 years [SD 7], 1656 [51·6%] male). Clinically important atrial fibrillation occurred in 103 (6·4%) of 1608 patients assigned to colchicine, and 120 (7·5%) of 1601 patients assigned to placebo (hazard ratio [HR] 0·85, 95% CI 0·65 to 1·10; absolute risk reduction [ARR] 1·1%, 95% CI -0·7 to 2·8; p=0·22). MINS occurred in 295 (18·3%) patients assigned to colchicine and 325 (20·3%) patients assigned to placebo (HR 0·89, 0·76 to 1·05; ARR 2·0%, -0·8 to 4·7; p=0·16). The composite outcome of sepsis or infection occurred in 103 (6·4%) patients in the colchicine group and 83 (5·2%) patients in the placebo group (HR 1·24, 0·93-1·66). Non-infectious diarrhoea was more common in the colchicine group (134 [8·3%] events) than the placebo group (38 [2·4%]; HR 3·64, 2·54-5·22).InterpretationIn patients undergoing major non-cardiac thoracic surgery, administration of colchicine did not significantly reduce the incidence of clinically important atrial fibrillation or MINS but increased the risk of mostly benign non-infectious diarrhoea.FundingCanadian Institutes of Health Research, Accelerating Clinical Trials Consortium, Innovation Fund of the Alternative Funding Plan for the Academic Health Sciences Centres of Ontario, Population Health Research Institute, Hamilton Health Sciences, Division of Cardiology at McMaster University, Canada; Hanela Foundation, Switzerland; and General Research Fund, Research Grants Council, Hong Kong.Copyright © 2023 Elsevier Ltd. All rights reserved.

34 keywords...

hide…