Post-Operative Pericardial Effusion-2 - POPE-2
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.
- Placebo Controlled
- 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%
- Allergy to colchicine
- Cardiac transplantation or correction of congenital anomaly
- Change in pericardial effusion grade
- Incidence of cardiac tamponade
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.
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).
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.
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.
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