POPE-2: Colchicine failed to reduce postoperative pericardial effusion

BARCELONA, Spain — Colchicine is not an effective treatment for patients who develop postoperative pericardial effusion, researchers for the POPE-2 study concluded at ESC Congress.

“Colchicine neither reduced the volume of effusions or prevented the occurrence of cardiac tamponade,” Philippe Meurin, MD, from Le Centre de Réadaptation Cardiaque Prés in Villeneuve Saint Denis, France, said in a press release.

POPE-2 was a randomized, double blind, placebo-controlled study conducted at 10 centers in France. Researchers enrolled 197 consecutive patients (mean age, 64 years; 86% men) with moderate to large postoperative pericardial effusions (grade 2 or higher) between 7 and 30 days after cardiac surgery.

Patients were randomly assigned to colchicine (n=98) or matching placebo (n=99) for 14 days. The colchicine was dosed according to patient weight. Those weighing 70 kg or more received a loading dose of 1 mg twice daily on day 1 followed by a maintenance dose of 1 mg daily for 14 days. Those weighing less than 70 kg received 1 mg daily with no loading dose.

The primary endpoint was change in pericardial effusion grade after treatment. The secondary endpoint was cardiac tamponade.

According to results presented, there was no difference after 14 days of treatment in the mean decrease in postoperative pericardial effusion grade from baseline (colchicine, –1.3%; placebo, –1.1%; P=.23).

Thirteen cases of cardiac tamponade were reported; seven were in the placebo group and six in the colchicine group (P=.8).

Meurin noted that this study was underpowered to evaluate adverse clinical events.

“Colchicine has been shown to be effective in other pericardial conditions — both the treatment of pericarditis, as well as the prevention of postpericardiotomy syndrome — so it was reasonable to explore its utility in treatment postoperative pericardial effusion. But in the POPE-2 study, in which we had to screen over 8,000 individuals to identify 197 cases, colchicine was no better than placebo at reducing the effusion and the risk of cardiac tamponade,” Meurin said in a press release.

For more information:

Meurin P. Hot Line I. Cardiovascular Disease: Novel Therapies. Presented at: the European Society of Cardiology Congress; Aug. 30-Sept. 3, 2014; Barcelona, Spain.

Disclosure: The study was funded by the French Society of Cardiology and the French Federation of Cardiology. Laboratoires Mayoly-Spindler provided colchicine and matched placebo. Meurin reports no relevant financial disclosures.