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

Conen, David; Popova, Ekaterine; Wang, Michael Ke; Chan, Matthew T.V.; Landoni, Giovanni; Reimer, Cara; Srinathan, Sadeesh; Cata, Juan P.; McLean, Sean R.; Reyes, Juan Carlos Trujillo; Grande, Ascensión Martín; Tallada, Anna Gonzalez; 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; Wells, Jennifer R.; McIntyre, William F.; Blum, Steffen; Ofori, Sandra; Vincent, Jessica; Xu, Lizhen; Li, Zhuoru; Healey, Jeff S.; Garg, Amit X.; Devereaux, P.J.

doi:10.1016/j.ahj.2023.01.018

Cited by 4 publications

(15 citation statements)

References 54 publications

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“…Six studies reported LOS. 1,7,[9][10][11][12] Generally, no significant difference in overall length of hospital stay was seen with…”

Section: Losmentioning

confidence: 99%

“…Postoperative atrial fibrillation (POAF) is a serious complication after major cardiac and thoracic surgery and is associated with adverse outcomes, such as increased risk of stroke and prolonged hospital stay. 1 Besides atrial trauma as the plausible reason, other factors, including surgery-related pericardial inflammation, dysautonomia, and changes in blood volume regulation, may play a role in its pathogenesis. 2 Because inflammatory processes are known to play an essential role in the pathogenesis of POAF, there has been significant interest in the potential use of anti-inflammatory agents, such as colchicine, as therapeutics.…”

Section: Introductionmentioning

confidence: 99%

“…2 Because inflammatory processes are known to play an essential role in the pathogenesis of POAF, there has been significant interest in the potential use of anti-inflammatory agents, such as colchicine, as therapeutics. 1 Colchicine inhibits microtubule polymerization by binding to tubulin, thus affecting any process that requires cytoskeletal changes, including neutrophil motility. 3 Colchicine was associated with reduced systemic inflammatory response after coronary artery bypass grafting and extracorporeal circulation.…”

Section: Introductionmentioning

confidence: 99%

“…5 Since then, colchicine has been evaluated in several randomized controlled trials (RCTs) to prevent POAF in patients undergoing cardiothoracic surgery, yet their results were equivocal. 1,[5][6][7][8][9][10][11][12][13] To address this, we conducted a meta-analysis to evaluate colchicine's efficacy and safety in POAF prevention in patients after major cardiothoracic surgery. This updated metaanalysis is the most extensive to date and has included the latest RCTs and a larger number of participants.…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and Safety of Colchicine for the Prevention of Postoperative Atrial Fibrillation Among Patients Undergoing Major Cardiothoracic Surgery: A Meta-analysis and Meta-regression of Randomized Controlled Trials

Rivera,

Whoy Cha,

Aparece

et al. 2024

Journal of Cardiovascular Pharmacology

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The role of colchicine for the prevention of postoperative atrial fibrillation (POAF) following cardiothoracic surgery is not well-established. We aimed to evaluate its potential in preventing POAF using data from randomized controlled trials (RCTs). A literature search was performed to identify studies reporting POAF as an outcome after cardiac or thoracic surgery in adult patients randomized to either colchicine or placebo. Primary outcome measured was incidence of POAF. Secondary outcomes included gastrointestinal (GI) adverse effects, sepsis, and length of stay (LOS). Subgroup analyses based on treatment durations and type of surgery were also performed, as well as regression analyses to control for covariates. We identified a total of 5,377 patients (colchicine = 2,689, placebo = 2,688). While colchicine use was associated with a significantly reduced risk for POAF, risk for GI adverse effects were significantly higher. Rates of infection and LOS were similar across the groups. Subgroup analyses showed that colchicine was effective for POAF prevention in cardiac surgery but not in thoracic surgery. Prevention of PAOF and incidence of GI adverse effects were similar in short-term and long-term colchicine treatment. Colchicine significantly reduces the incidence of POAF in patients undergoing cardiac surgery, but not in thoracic surgery.

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“…Six studies reported LOS. 1,7,[9][10][11][12] Generally, no significant difference in overall length of hospital stay was seen with…”

Section: Losmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Efficacy and Safety of Colchicine for the Prevention of Postoperative Atrial Fibrillation Among Patients Undergoing Major Cardiothoracic Surgery: A Meta-analysis and Meta-regression of Randomized Controlled Trials

Rivera,

Whoy Cha,

Aparece

et al. 2024

Journal of Cardiovascular Pharmacology

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“…[14][15][16] A new trial, "Colchicine for the prevention of perioperative atrial fibrillation in patients undergoing thoracic surgery," is currently underway at 40 centers in 11 countries until 2023 (NCT03310125). 17 Colchicine for the prevention of perioperative atrial fibrillation is planning to enroll 3200 patients. Patients are randomly assigned to receive colchicine (0.5 mg) or placebo, twice daily starting 2 to 4 hours before surgery for a total of 10 days.…”

Section: Introductionmentioning

confidence: 99%

Effect of Colchicine on the Risk of Perioperative Acute Kidney Injury: Clinical Protocol of a Substudy of the Colchicine for the Prevention of Perioperative Atrial Fibrillation Randomized Clinical Trial

Garg

Cuerden

Cata

et al. 2023

Can J Kidney Health Dis

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Background: Inflammation during and after surgery can lead to organ damage including acute kidney injury. Colchicine, an established inexpensive anti-inflammatory medication, may help to protect the organs from pro-inflammatory damage. This protocol describes a kidney substudy of the colchicine for the prevention of perioperative atrial fibrillation (COP-AF) study, which is testing the effect of colchicine versus placebo on the risk of atrial fibrillation and myocardial injury among patients undergoing thoracic surgery. Objective: Our kidney substudy of COP-AF will determine whether colchicine reduces the risk of perioperative acute kidney injury compared with a placebo. We will also examine whether colchicine has a larger absolute benefit in patients with pre-existing chronic kidney disease, the most prominent risk factor for acute kidney injury. Design and Setting: Randomized, superiority clinical trial conducted in 40 centers in 11 countries from 2018 to 2023. Patients: Patients (~3200) aged 55 years and older having major thoracic surgery. Intervention: Patients are randomized 1:1 to receive oral colchicine (0.5 mg tablet) or a matching placebo, given twice daily starting 2 to 4 hours before surgery for a total of 10 days. Patients, health care providers, data collectors, and outcome adjudicators will be blinded to the randomized treatment allocation. Methods: Serum creatinine concentrations will be measured before surgery and on postoperative days 1, 2, and 3 (or until hospital discharge). The primary outcome of the substudy is perioperative acute kidney injury, defined as an increase (from the prerandomization value) in serum creatinine concentration of either ≥26.5 μmol/L (≥0.3 mg/dL) within 48 hours of surgery or ≥50% within 7 days of surgery. The primary analysis (intention-to-treat) will examine the relative risk of acute kidney injury in patients allocated to receive colchicine versus placebo. We will repeat the primary analysis using alternative definitions of acute kidney injury and examine effect modification by pre-existing chronic kidney disease, defined as a prerandomization estimated glomerular filtration rate (eGFR) <60 mL/min per 1.73 m2. Limitations: The substudy will be underpowered to detect small effects on more severe forms of acute kidney injury treated with dialysis. Results: Substudy results will be reported in 2024. Conclusions: This substudy will estimate the effect of colchicine on the risk of perioperative acute kidney injury in older adults undergoing major thoracic surgery. Clinical trial registration number: NCT03310125

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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

Tallada¹,

McIntyre²,

Wong³

et al. 2023

The Lancet

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

Cited by 4 publications

References 54 publications

Efficacy and Safety of Colchicine for the Prevention of Postoperative Atrial Fibrillation Among Patients Undergoing Major Cardiothoracic Surgery: A Meta-analysis and Meta-regression of Randomized Controlled Trials

Efficacy and Safety of Colchicine for the Prevention of Postoperative Atrial Fibrillation Among Patients Undergoing Major Cardiothoracic Surgery: A Meta-analysis and Meta-regression of Randomized Controlled Trials

Effect of Colchicine on the Risk of Perioperative Acute Kidney Injury: Clinical Protocol of a Substudy of the Colchicine for the Prevention of Perioperative Atrial Fibrillation Randomized Clinical Trial

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

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