Article Text

other Versions

PDF
Original article
Colchicine for postoperative pericardial effusion: a multicentre, double-blind, randomised controlled trial
  1. P Meurin1,
  2. S Lelay-Kubas2,
  3. B Pierre3,
  4. H Pereira4,5,
  5. B Pavy6,
  6. M C Iliou7,
  7. J L Bussière8,
  8. H Weber1,
  9. J P Beugin9,
  10. T Farrokhi10,
  11. A Bellemain-Appaix11,
  12. L Briota12,
  13. J Y Tabet1,13,
  14. for the French Society of Cardiology
  1. 1Department of Cardiology, Les Grands Prés (CRCB), Villeneuve St Denis, France
  2. 2Centre de Réadaptation Bois Gibert, Ballan Mire, France
  3. 3IRIS, Marcy l’étoile, France
  4. 4Assistance Publique, Hôpitaux de Paris, Hôpital Européen Georges-Pompidou, Unité d'Épidémiologie et de Recherche Clinique, Paris, France
  5. 5INSERM, Centre d'Investigation Clinique 1418, module Épidémiologie Clinique, Paris, France
  6. 6Centre Hospitalier Loire Vendée Océan, Machecoul, France
  7. 7Corentin-Celton Hospital, Issy Les Moulineaux, France
  8. 8Clinique De Chatillon, Châtillon, France
  9. 9Clinique de la Mitterie 195 rue Adolphe Defrenne, Lomme, France
  10. 10Bligny Hospital, Briis-sous-Forges, France
  11. 11La Maison du Mineur, Vence, France
  12. 12Centre Dieuleufit santé, Dieulefit, France
  13. 13Private Hospital Jacques Cartier, Institut cardiovasculaire Paris Sud, Massy, France
  1. Correspondance to Dr P Meurin, Department of Cardiology, Les Grands Prés, 27 rue Sainte Christine, Villeneuve Saint Denis 77174, France; philippemeurin{at}hotmail.com

Abstract

Objectives Pericardial effusion is common after cardiac surgery. Growing evidence suggests that colchicine may be useful for acute pericarditis, but its efficacy in reducing pericardial effusion volume postoperatively has not been assessed.

Methods This randomised, double-blind, placebo-controlled study conducted in 10 centres in France included 197 patients at high risk of tamponade (ie, with moderate to large-sized persistent effusion (echocardiography grades 2, 3 or 4 on a scale of 0–4)) at 7–30 days after cardiac surgery. Patients were randomly assigned to receive colchicine, 1 mg daily (n=98), or a matching placebo (n=99). The main end point was change in pericardial effusion grade after 14-day treatment. Secondary end points included frequency of late cardiac tamponade.

Results The placebo and the colchicine groups showed a similar mean baseline pericardial effusion grade (2.9±0.8 vs 3.0±0.8) and similar mean decrease from baseline after treatment (−1.1±1.3 vs −1.3±1.3 grades). The mean difference in grade decrease between groups was −0.19 (95% CI −0.55 to 0.16, p=0.23). In total, 13 cases of cardiac tamponade occurred during the 14-day treatment (7 and 6 in the placebo and colchicine groups, respectively; p=0.80). At 6-month follow-up, all patients were alive and had undergone a total of 22 (11%) drainages: 14 in the placebo group and 8 in the colchicine group (p=0.20).

Conclusions In patients with pericardial effusion after cardiac surgery, colchicine administration does not reduce the effusion volume or prevent late cardiac tamponade.

Clinical trial reg No NCT01266694.

View Full Text

Statistics from Altmetric.com

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

Linked Articles