COlchicine for Prevention of the Postpericardiotomy Syndrome and Postoperative Atrial Fibrillation - COPPS 2

Aug 30, 2014
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Azienda Sanitaria 3, Acarpia, and FAR.G.IM
Date Presented:
01/01/2014
Date Published:
01/01/2014
Date Updated:
08/30/2014
Original Posted Date:
08/30/2014
References

Description:

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

Hypothesis:

Colchicine will prevent postpericardiotomy syndrome, postoperative atrial fibrillation, and postoperative effusions.

Study Design

  • Placebo Controlled
  • Randomized
  • Blinded
  • Parallel

Patient Populations:

  • Participants at least 18 years of age undergoing cardiac surgery

    Number of screened applicants: 758
    Number of enrollees: 360
    Duration of follow-up: 3 months
    Mean patient age: 67 years
    Percentage female: 26%
    Ejection fraction: 55%
    NYHA class: I: 32%; II: 53%; III: 13%; IV: 2%

Exclusions:

  • Current atrial fibrillation
  • Candidate for cardiac transplantation
  • Severe liver or renal disease
  • Myopathy
  • Chronic intestinal disease or blood dyscrasia
  • Pregnancy
  • Hypersensitivity to colchicine
  • Current treatment with colchicine

Primary Endpoints:

  • Postpericardiotomy syndrome within 3 months, based on at least two of the following criteria:
    - Fever without alternative cause
    - Pleuritic chest pain
    - Friction rub
    - New or worsening pleural effusion
    - New or worsening pericardial effusion

Secondary Endpoints:

  • Postoperative atrial fibrillation
  • Postoperative effusions (pleural and/or pericardial)

Drug/Procedures Used:

Participants undergoing cardiac surgery were randomized to colchicine 0.5 mg twice daily 48-72 hours before surgery (n = 180) versus placebo (n = 180). Study drugs were continued for 1 month. Participants <70 kg received colchicine 0.5 mg daily.

Principal Findings:

Overall, 360 participants were randomized. The mean age was 67 years, 26% were women, 27% were current smokers, and 21% had diabetes. The mean left ventricular ejection fraction was 55%. Type of surgery was coronary artery bypass grafting in 35%, valvular in 34%, aortic in 6%, and combined in 25%.

The primary outcome of postpericardiotomy syndrome occurred in 19.4% of the colchicine group vs. 29.4% of the placebo group (p < 0.05).

- Postoperative atrial fibrillation: 33.9% vs. 41.7% (p = not significant [NS]), respectively
- Postoperative effusions: 57.2% vs. 58.9% (p = NS), respectively
- Gastrointestinal intolerance: 14.4% vs. 6.7% (p < 0.05), respectively

Interpretation:

Among participants undergoing cardiac surgery, colchicine appeared to be effective at reducing the incidence of postpericardiotomy syndrome compared with placebo. However, this medication did not reduce the incidence of postoperative atrial fibrillation or postoperative effusions.

Several components of the primary outcome were subjective in nature, which could explain why benefit was observed in the primary outcome, but not the secondary outcomes. Colchicine was also associated with an increased incidence of gastrointestinal intolerance.

References:

Imazio M, Brucato A, Ferrazzi P, et al., on behalf of the COPPS-2 Investigators. Colchicine for Prevention of Postpericardiotomy Syndrome and Postoperative Atrial Fibrillation: The COPPS-2 Randomized Clinical Trial. JAMA 2014;Aug 30:[Epub ahead of print].

Presented by Dr. Massimo Imazio at the European Society of Cardiology Congress, Barcelona, Spain, August 30, 2014.

Keywords: Colchicine, Stroke Volume, Postpericardiotomy Syndrome, Coronary Artery Bypass, Cardiac Surgical Procedures, Diabetes Mellitus, Postoperative Period, ESC Congress


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