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http://hdl.handle.net/11375/29541
Title: | Effect of colchicine on perioperative atrial fibrillation and myocardial injury after noncardiac surgery in patients undergoing major thoracic surgery – the COP-AF randomised controlled trial |
Other Titles: | COP-AF |
Authors: | Conen, David Wang, Michael Ke Popova, Ekaterine Chan, Matthew TV Landoni, Giovanni Cata, Juan P. Reimer, Cara McLean, Sean R. Srinathan, Sadeesh K. Trujillo Reyes, Juan Carlos Grande, Ascension Martín Gonzalez Tallada, Anna Sessler, Daniel I. Fleischmann, Edith Kabon, Barbara Voltolini, Luca Cruz, P. Maziak, Donna E. Gutiérrez-Soriano, Laura McIntyre, William F. Tandon, Vikas Martínez-Téllez, Elisabeth Guerra-Londono, Juan Jose DuMerton, Deborah Wong, Randolph HL McGuire, Anna L. Kidane, Biniam Parise Roux, Diego Shargall, Yaron Wells, Jennifer R. Ofori, Sandra N. Vincent, Jessica Xu, Lizhen Li, Zhuoru Eikelboom, John W. Jolly, Sanjit S. Healey, Jeff S. Devereaux, PJ |
Department: | Medicine |
Keywords: | Colchicine;inflammation;atrial fibrillation;myocardial injury;prevention;thoracic surgery |
Publication Date: | 25-Aug-2023 |
Publisher: | The Lancet |
Citation: | Conen D, Ke Wang M, Popova E, Chan MTV, Landoni G, Cata JP, Reimer C, McLean SR, Srinathan SK, Reyes JCT, Grande AM, Tallada AG, Sessler DI, Fleischmann E, Kabon B, Voltolini L, Cruz P, Maziak DE, Gutiérrez-Soriano L, McIntyre WF, Tandon V, Martínez-Téllez E, Guerra-Londono JJ, DuMerton D, Wong RHL, McGuire AL, Kidane B, Roux DP, Shargall Y, Wells JR, Ofori SN, Vincent J, Xu L, Li Z, Eikelboom JW, Jolly SS, Healey JS, Devereaux PJ; COP-AF Investigators. Effect of colchicine on perioperative atrial fibrillation and myocardial injury after non-cardiac surgery in patients undergoing major thoracic surgery (COP-AF): an international randomised trial. Lancet. 2023 Aug 25:S0140-6736(23)01689-6. doi: 10.1016/S0140-6736(23)01689-6. Epub ahead of print. PMID: 37640035. |
Abstract: | Background Higher levels of inflammatory biomarkers are associated with an increased risk of perioperative atrial fibrillation (AF) and myocardial injury after noncardiac surgery (MINS). Colchicine is an anti-inflammatory drug that may prevent these complications. Methods We performed an international, randomised trial at 45 sites in 11 countries. Patients aged ≥55 years and undergoing major noncardiac thoracic surgery were randomised to receive oral colchicine 0·5mg twice daily or matching placebo, starting within four hours before surgery and continuing for ten days. Healthcare providers, patients, data collectors, and adjudicators were blinded to treatment assignment. The co-primary outcomes were clinically important perioperative AF and MINS during 14 days of follow-up. This trial is registered at ClinicalTrials.gov (NCT03310125). Findings We enrolled 3209 patients between February 14, 2018, and June 27, 2023. Clinically important AF developed in 103 of 1608 (6·4%) patients assigned to colchicine, and 120 of 1601 (7·5%) patients assigned to placebo, hazard ratio (HR) 0·85 (95% confidence interval [CI] 0·65-1·10), absolute risk reduction (ARR) 1·1%, 95% CI -0·7-2·8, p=0.22. MINS occurred in 295 (18·3%) patients assigned to colchicine, and 325 (20·3%) patients assigned to placebo, HR 0·89 (95% CI 0·76-1·05), ARR 2·0%, 95% CI -0·8-4·7, p=0.16. Non-infectious diarrhoea was more common in the colchicine group, 134 (8·3%) versus 38 (2·4%) events, HR 3·64 (95% CI 2·54-5·22), but did not prolong median length of hospital stay and led to only one readmission.. Interpretation In patients undergoing major noncardiac thoracic surgery, administration of colchicine did not significantly reduce the incidence of the co-primary outcomes clinically important AF or MINS. While colchicine increased the risk of mostly benign non-infectious diarrhoea, there was an encouraging trend of fewer cardiovascular events with colchicine that requires further research. |
Rights: | This content is published Open Access under Creative Commons license: Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) |
URI: | http://hdl.handle.net/11375/29541 |
Identifier: | https://doi.org/10.1016/S0140-6736(23)01689-6 |
Appears in Collections: | Medicine Publications |
Files in This Item:
File | Description | Size | Format | |
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COP-AF Main paper Revision1 final clean no endnote.docx | 49.1 kB | Microsoft Word XML | View/Open | |
COP-AF_Results Paper_Supplementary Appendix_2023-08-05.docx | 46.34 kB | Microsoft Word XML | View/Open | |
COP-AF Main paper Figure 1_revised.docx | 40.09 kB | Microsoft Word XML | View/Open | |
Figure2_A_Clinical_important_AF_02AUG23.pdf | 77.58 kB | Adobe PDF | View/Open | |
Figure2_B_MINS_02AUG23.pdf | 77.58 kB | Adobe PDF | View/Open | |
Figure3_A_forest_plot_primary_CPAF_01AUG23.pdf | 158.66 kB | Adobe PDF | View/Open | |
Figure3_B_forest_plot_primary_MINS_01AUG23.pdf | 158.61 kB | Adobe PDF | View/Open |
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