COlchicine for the Prevention of the Post-pericardiotomy Syndrome - COPPS
The goal of the trial was to evaluate treatment with colchicine compared with placebo among patients undergoing cardiac surgery.
Colchicine will be more effective in preventing the post-pericardiotomy syndrome.
- Placebo Controlled
- Patients undergoing cardiac surgery at least 18 years of age
Number of enrollees: 360
Duration of follow-up: 1 year
Age range: mean 65 years
Percentage female: 31%
Ejection fraction: mean 54%
New York Heart Association class: I-II: 71%; III-IV: 30%
- Limited life span
- Contraindication to colchicine
- Severe liver disease or transaminase >1.5 x the upper limit of normal
- Serum creatinine >2.5 mg/dl
- Myopathy or elevated preoperative creatine kinase
- Blood dyscrasia
- Gastrointestinal disease
- The incidence of post-pericardiotomy syndrome at 1 year
- Post-pericardiotomy syndrome was diagnosed by at least two of the following:
o Fever after the first postoperative week without evidence for infection
o Pleuritic chest pain
o Friction rub
o Pleural effusion
o Pericardial effusion
- Combined incidence of disease-related hospitalization, cardiac tamponade, constrictive pericarditis, and relapses
Three days after cardiac surgery, eligible patients were randomized to colchicine 1 mg twice daily for the first day, then 0.5 mg twice daily for 1 month (n = 180) versus placebo (n = 180). Patients <70 kg received one-half of the maintenance dose of colchicine.
Overall, 360 patients were randomized. In the colchicine group, the mean age was 65 years, 31% were women, 22% had diabetes, 18% had a creatinine clearance <60 ml/min, and mean left ventricular ejection fraction was 54%. In 51%, the type of surgery was coronary artery bypass grafting, in 28% it was valvular surgery, and in 17% it was combined coronary/valvular surgery.
The incidence of the primary outcome, post-pericardiotomy syndrome at 1 year, was 8.9% in the colchicine group versus 21.1% in the placebo group (p = 0.0002). Most (85%) of these events occurred in the first month. The incidence of the combined secondary endpoint was 0.6% versus 5.0% (p = 0.024), respectively. Side effects (gastrointestinal intolerance) and drug withdrawal were 8.9% versus 5.0% (p = 0.21), respectively.
After cardiac surgery, the use of 1 month of colchicine was beneficial at preventing the post-pericardiotomy syndrome and its related complications. Colchicine appeared to be well tolerated with a similar rate of side effects and drug discontinuation compared with placebo. Although confirmatory reports are needed, this agent appears to be a safe and effective mechanism to prevent what can be a serious and disabling complication of cardiac surgery.
Imazio M, Trinchero R, Brucato A, et al.; on behalf of the COPPS Investigators. COlchicine for the prevention of the Post-pericardiotomy Syndrome (COPPS): a multicentre, randomized, double-blind, placebo-controlled trial. Eur Heart J 2010;Aug 30:[Epub ahead of print].
Keywords: Pericardiectomy, Colchicine, Stroke Volume, Postpericardiotomy Syndrome, Creatinine, Coronary Artery Bypass, Cardiac Surgical Procedures, Diabetes Mellitus, Primary Prevention
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