Arrhythmias & electrophysiologyRandomised controlled 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
- Randomised controlled trial
- placebo-controlled
- masked
- multicentre (45 sites, 11 countries)
- stratified by centre
Authors' conclusion
In 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.
Study context
- Population
- Patients aged ≥55 years undergoing major non-cardiac thoracic surgery
- Participants
- 3,209 patients
- Comparison
- Colchicine vs placebo
- Colchicinen = 1,608
- Placebon = 1,601reference
- Primary endpoint
- Coprimary: clinically important perioperative AF and MINS (myocardial injury after non-cardiac surgery)
- Follow-up
- 14 days
Primary result
As reported in the abstract
Colchicine
103 (6.4%)
Clinically important AF · MINS 295 (18.3%)
Placebo
120 (7.5%)
Clinically important AF · MINS 325 (20.3%)
Colchicine vs PlaceboHRP value
clinically important AF; ARR 1.1% (95% CI −0.7 to 2.8)
0.85(95% CI 0.65–1.10)
P = 0.22MINS; ARR 2.0% (−0.8 to 4.7)
0.89(CI 0.76–1.05)
P = 0.16Safety
| Outcome | Colchicine | Placebo | HR (CI) | |
|---|---|---|---|---|
| Sepsis or infection (composite) | 6.4% | 5.2% | 1.24 (0.93–1.66) | |
| Non-infectious diarrhoea · events | 8.3% | 2.4% | 3.64 (2.54–5.22) | |
| 0.20.5125Hazard ratio (log scale) |
Original publication
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. Published 25 August 2023. doi:10.1016/s0140-6736(23)01689-6
Summarised from the published abstract; every number is checked against it