Colchicine for the Prevention of the Post-Pericardiotomy Syndrome Atrial Fibrillation Substudy - COPPS POAF
The goal of the trial was to compare treatment with colchicine compared with placebo among patients undergoing cardiac surgery.
Colchicine will prevent postoperative atrial fibrillation.
- Patients at least 18 years of age in sinus rhythm undergoing cardiac surgery
Number of screened applicants: 600
Number of enrollees: 336
Mean patient age: 65 years
Percentage female: 30%
- Chronic atrial fibrillation
- Persistent postoperative atrial fibrillation on day 3 before starting colchicine
- Severe liver disease
- Renal insufficiency (creatinine >2.5 mg/dl)
- Gastrointestinal disease
- Bleeding disorder
- Myopathy or elevated preoperative creatine kinase
- Pregnant or lactating women
- Hypersensitivity to colchicine
- Current treatment with colchicine
- Limited life span
- Postoperative atrial fibrillation at 1 month
Eligible patients undergoing cardiac surgery were randomized to colchicine 1 mg twice daily for 1 day, then 0.5 mg twice daily (n = 169) versus placebo (n = 167). Study medications were started on day 3.
Overall, 336 patients were randomized. The mean age was 65 years, 30% were women, 20% had diabetes, 54% had coronary artery bypass grafting, 25% had valvular surgery, 2% had aortic surgery, and 17% had combined surgery.
The primary outcome, postoperative atrial fibrillation, occurred in 12% of the colchicine group versus 22% of the placebo group (p = 0.021).
Hospital duration was 9 days versus 10 days (p = 0.04), rehabilitation duration was 12 days versus 14 days (p = 0.009), and death or stroke was 1.2% versus 1.2% (p = 0.62), respectively for colchicine versus placebo.
Gastrointestinal side effects occurred in 9.5% versus 4.2% (p = 0.082), and drug withdrawal occurred in 11.8% versus 6.6% (p = 0.13), respectively.
Among patients undergoing cardiac surgery, the use of colchicine prevented postoperative atrial fibrillation compared with placebo. There was a nonsignificant increase in gastrointestinal side effects with colchicine. Confirmatory studies are needed.
Imazio M, Brucato A, Ferrazzi P, et al., on behalf of the COPPS Investigators. Colchicine Reduces Postoperative Atrial Fibrillation: Results of the Colchicine for the Prevention of the Postpericardiotomy Syndrome (COPPS) Atrial Fibrillation Substudy. Circulation 2011;Nov 16:[Epub ahead of print].
Presented by Dr. Massimo Imazio at the American Heart Association Scientific Sessions, Orlando, FL, November 16, 2011.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention
Keywords: Stroke, Colchicine, Coronary Artery Bypass, Cardiac Surgical Procedures, Diabetes Mellitus, Postoperative Period
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