Conen David, Popova Ekaterine, Wang Michael Ke, Chan Matthew T V, Landoni Giovanni, Reimer Cara, Srinathan Sadeesh K, Cata Juan P, McLean Sean R, Trujillo Reyes Juan Carlos, Grande Ascensión Martín, Gonzalez Tallada Anna, Sessler Daniel I, Fleischmann Edith, Maziak Donna E, Kabon Barbara, Voltolini Luca, Gutiérrez-Soriano Laura, Tandon Vikas, DuMerton Deborah, Kidane Biniam, Rajaram Ravi, Shargall Yaron, Neary John D, Wells Jennifer R, McIntyre William F, Blum Steffen, Ofori Sandra N, Vincent Jessica, Xu Lizhen, Li Zhuoru, Healey Jeff S, Garg Amit X, Devereaux P J
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.
Biomedical Research Institute (IIB Sant Pau), Barcelona, Spain; Iberoamerican Cochrane Centre, Barcelona, Spain.
Am Heart J. 2023 May;259:87-96. doi: 10.1016/j.ahj.2023.01.018. Epub 2023 Feb 7.
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.
围手术期房颤（AF）和非心脏手术后心肌损伤（MINS）是非心脏手术后常见的并发症。炎症与这两种疾病的发病机制有关。COP-AF试验检验了秋水仙碱可降低接受非心脏大手术患者围手术期房颤和MINS发生率的假设。
“预防围手术期房颤的秋水仙碱”（COP-AF）试验是一项国际、双盲、随机试验，在年龄至少55岁且接受全身麻醉的非心脏大手术患者中比较秋水仙碱与安慰剂。排除标准包括房颤病史和秋水仙碱禁忌症（如严重肾功能不全）。在手术前4小时内给予0.5mg口服秋水仙碱或匹配的安慰剂。此后，患者每天接受两次0.5mg秋水仙碱或安慰剂，共10天。两个独立的共同主要结局是随访14天期间具有临床意义的围手术期房颤（包括心房扑动）和MINS。主要安全结局是败血症或感染以及非感染性腹泻。我们的目标是从11个国家的约40个地点招募3200名患者，以便对两个共同主要结局进行独立评估时具有至少80%的检验效能。COP-AF的主要结果预计在2023年得出。
COP-AF是一项大型随机双盲试验，旨在确定秋水仙碱是否能降低接受非心脏大手术患者围手术期房颤或MINS的风险。
