COlchicine for the Prevention of the Post-pericardiotomy Syndrome - COPPS

Sep 15, 2010
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Date Published:
01/01/2010
Date Updated:
09/15/2010
Original Posted Date:
09/15/2010
References

Description:

The goal of the trial was to evaluate treatment with colchicine compared with placebo among patients undergoing cardiac surgery.

Hypothesis:

Colchicine will be more effective in preventing the post-pericardiotomy syndrome.

Study Design

  • Blinded
  • Parallel
  • Placebo Controlled
  • Randomized

Patient Populations:

  • 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%

Exclusions:

  • 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
  • Pregnancy

Primary Endpoints:

  • 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

Secondary Endpoints:

  • Combined incidence of disease-related hospitalization, cardiac tamponade, constrictive pericarditis, and relapses

Drug/Procedures Used:

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.

Principal Findings:

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.

Interpretation:

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.

References:

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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