Post-Operative Pericardial Effusion-2 - POPE-2

Dec 18, 2015
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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:
French Society of Cardiology and Mayoly-Spindler
Date Presented:
08/30/2014
Date Published:
11/01/2015
Date Updated:
12/18/2015
Original Posted Date:
08/30/2014
References

Description:

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

Contribution to the Literature: The POPE-2 trial failed to show that colchicine reduced postoperative pericardial effusion volume.

Study Design

  • Placebo Controlled
  • Randomized
  • Blinded
  • Parallel

Patient Populations:

  • Participants with moderate to large pericardial effusion 7-30 days after cardiac surgery

    Number of screened applicants: 8,140
    Number of enrollees: 197
    Duration of follow-up: 6 months
    Mean patient age: 64 years
    Percentage female: 14%

Exclusions:

  • Allergy to colchicine
  • Cardiac transplantation or correction of congenital anomaly

Primary Endpoints:

  • Change in pericardial effusion grade

Secondary Endpoints:

  • Incidence of cardiac tamponade

Drug/Procedures Used:

Patients with moderate to large pericardial effusion after cardiac surgery were randomized to colchicine 2 mg loading dose, then 1 mg daily (n = 98) versus placebo (n = 99) for 14 days. Patients <70 kg received colchicine 1 mg daily without a loading dose.

Principal Findings:

Overall, 197 patients were randomized. The mean age was 64 years and 86% were male. Surgical procedures were coronary artery bypass grafting in 59%, aortic valve replacement in 35%, mitral valve repair/replacement in 27%, and ascending aorta replacement in 15%.

The initial mean pericardial effusion grade was 3.0 for colchicine and 2.9 for placebo (grade 1 = small, grade 4 = large). Pericardial effusion grade decreased by 1.3 points in the colchicine group and 1.1 points in the placebo group (p = 0.23).

At 14 days, six cases of tamponade occurred in the colchicine group versus seven cases in the placebo group (p = 0.80). The incidence of tamponade was also similar at 6 months (p = 0.20). At 6 months, eight surgical pericardiotomies occurred in the colchicine group versus 14 surgical pericardiotomies in the placebo group (p = 0.20).

Interpretation:

Patients with moderate to large pericardial effusion at least 7 days after cardiac surgery are at risk of tamponade. Unfortunately, colchicine did not improve pericardial effusion grade or the incidence of tamponade. The POPE-1 study also found no benefit from nonsteroidal anti-inflammatory drugs in reducing severity of postoperative pericardial effusion.

References:

Meurin P, Lelay-Kubas S, Pierre B, et al. Colchicine for postoperative pericardial effusion: a multicentre, double-blind, randomised controlled trial. Heart 2015;101:1711-6.

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

Keywords: Heart Valve Prosthesis, Colchicine, Pyridinolcarbamate, Coronary Artery Bypass, Cardiac Surgical Procedures, Mitral Valve, Pericardial Effusion, ESC Congress


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