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Colchicine for Post- operative Pericardial Effusion: The post-operative pericardial effusion (POPE-2) Study. A multicenter, double-blind, randomized trial

ESC Congress 2014 - Hot Line report

Pericardial Disease


By Philippe Meurin, (Villeneuve-St.-Denis, France)
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List of Authors:
P. Meurin 1, LS. Lelay-Kubas 2, BP. Pierre 3, MCI. Iliou 4, BP. Pavy 5, JLB. Bussiere 6, JPB. Beugin 7, TF. Farrokhi 8, H. Pereira 9, JY. Tabet 1

(1) Les Grands Prés, Villeneuve Saint Denis, France (2) Centre de Réadaptation, Bois Gibert, France (3) I.R.I.S, Marcy L'étoile, France (4) Corentin Celton Hospital, Issy Les Moulineaux, France (5) Hospital Center Loire-Vendee-Ocean, Machecoul, France (6) Les Fauvettes, Chatillon, France (7) La Mitterie, Lomme, France (8) Hospital of Bligny, Briis Sous Forges, France (9) European Hospital Georges Pompidou, Paris, France


Background and objectives:
The objective of this prospective, double-blind, randomized multicenter study was to assess the efficacy of colchicine in reducing pericardial effusion volume and the incidence of post -operative cardiactamponades. After cardiac surgery, the incidence of pericardial effusion is high (50% to 85%). Cardiac tamponade occurs in 1% to 2% of patients. Early tamponade (during the first 7 days post-operatively) is due to surgical bleeding and accounts for about one third of all cases of tamponade. Early tamponades are usually easily diagnosed and treated because they occur while the patient is still in the intensive care unit. However, most tamponades occur more than 7 days after surgery and may develop slowly without clear-cut symptoms. This is a concern because at this time, patients have often been discharged from the hospital.
Growing evidence suggests that colchicine may be useful to treat acute pericarditis and to prevent -- not treat -- postpericardiotomy syndrome (PPS). However, PPS is a rare inflammatory post-injury syndrome that usually includes chest pain and fever and has little in common with asymptomatic post-operative pericardial effusion. Thus, colchicine efficacy in this latest setting remains unknown.
This was a prospective double-blind, randomized study conducted in 10 cardiac rehabilitation centers comparing colchicine versus placebo to reduce pericardial effusion in patients who underwent cardiac surgery within the previous 30 days. In total, 172 patients (86 in each group) were needed for 80% power to detect a significant difference between colchicine and placebo.
We prospectively screened 8 140 consecutive post-operative patients; 252 met the inclusion criteria: moderate to large pericardial effusion (grade 2, 3 or 4 on a scale of 0 to 4 as measured by echocardiography) persisting 7 to 30 days after cardiac surgery, which indicated high risk of cardiac tamponade within the next 2 weeks. Among these 252 patients, 197 could be included (see flow chart in the PDF file). Patients were randomly assigned to receive colchicine, 1 mg daily (n =98), or a matching placebo (n =99) for 14 days. The primary endpoint was change in pericardial effusion grade after 14-day treatment. A secondary endpoint was incidence of cardiac tamponade.
Patients were 64 years old on average, and 86% were male. Surgeries performed (total > 100 due to combined operations) were CABG (n =110, 56%), aortic valve replacement (n = 82, 42%), mitral valve replacement (n = 12, 4%), mitral valve repair (n = 14, 7%), and ascending aorta replacement (n= 30, 15%). The initial mean pericardial effusion grade was 2.9±0.8 and 3.0±0.8 in the placebo and colchicine groups, respectively (p=0.46). The placebo and the colchicine groups showed similar pericardial effusion grade reduction after treatment (- 1.1±1.3 vs - 1.3±1.3 grade, respectively, p=0.23). In all, 13 cases of cardiac tamponade (6.6%) occurred during the 14-day treatment (7 and 6 in the placebo and colchicine groups, respectively, p = 0.80). At 6-month follow-up, a total of 22 patients (11.2%) had required a pericardial drainage without significant difference between the 2 groups.
We confirm that persisting moderate to large pericardial effusion at 7 to 30 days after cardiac surgery is a severe condition. In these patients, the administration of colchicine did not reduce the volume of effusion or prevent the occurrence of cardiac tamponade.


By Jae K Oh, FESC (Rochester, United States of America)
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The content of this article reflects the personal opinion of the author/s and is not necessarily the official position of the European Society of Cardiology.