Colchicine for the Prevention of the Post-Pericardiotomy Syndrome Atrial Fibrillation Substudy - COPPS POAF

Nov 16, 2011
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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:
Italian National Healthcare System, Acarpia Lda.
Date Presented:
01/01/2011
Date Published:
01/01/2011
Date Updated:
11/16/2011
Original Posted Date:
11/16/2011
References

Description:

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

Hypothesis:

Colchicine will prevent postoperative atrial fibrillation.

Study Design

  • Randomized
  • Blinded
  • Parallel

Patient Populations:

  • 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%

Exclusions:

  • 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

Primary Endpoints:

  • Postoperative atrial fibrillation at 1 month

Drug/Procedures Used:

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.

Principal Findings:

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.

Interpretation:

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.

References:

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.

Keywords: Stroke, Colchicine, Coronary Artery Bypass, Cardiac Surgical Procedures, Diabetes Mellitus, Postoperative Period


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