title: Colchicine for postoperative pericardial effusion: a multicentre, double-blind, randomised controlled trial.
abstract: OBJECTIVE
  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.
  
  
  BACKGROUND
  NCT01266694.
authors.affiliation: Department of Cardiology, Les Grands Prés (CRCB), Villeneuve St Denis, France.
authors.forename: P
authors.initials: P
authors.lastname: Meurin
authors.affiliation: Centre de Réadaptation Bois Gibert, Ballan Mire, France.
authors.forename: S
authors.initials: S
authors.lastname: Lelay-Kubas
authors.affiliation: IRIS, Marcy l'étoile, France.
authors.forename: B
authors.initials: B
authors.lastname: Pierre
authors.affiliation: Assistance Publique, Hôpitaux de Paris, Hôpital Européen Georges-Pompidou, Unité d'Épidémiologie et de Recherche Clinique, Paris, France INSERM, Centre d'Investigation Clinique 1418, module Épidémiologie Clinique, Paris, France.
authors.forename: H
authors.initials: H
authors.lastname: Pereira
authors.affiliation: Centre Hospitalier Loire Vendée Océan, Machecoul, France.
authors.forename: B
authors.initials: B
authors.lastname: Pavy
authors.affiliation: Corentin-Celton Hospital, Issy Les Moulineaux, France.
authors.forename: M C
authors.initials: MC
authors.lastname: Iliou
authors.affiliation: Clinique De Chatillon, Châtillon, France.
authors.forename: J L
authors.initials: JL
authors.lastname: Bussière
authors.affiliation: Department of Cardiology, Les Grands Prés (CRCB), Villeneuve St Denis, France.
authors.forename: H
authors.initials: H
authors.lastname: Weber
authors.affiliation: Clinique de la Mitterie 195 rue Adolphe Defrenne, Lomme, France.
authors.forename: J P
authors.initials: JP
authors.lastname: Beugin
authors.affiliation: Bligny Hospital, Briis-sous-Forges, France.
authors.forename: T
authors.initials: T
authors.lastname: Farrokhi
authors.affiliation: La Maison du Mineur, Vence, France.
authors.forename: A
authors.initials: A
authors.lastname: Bellemain-Appaix
authors.affiliation: Centre Dieuleufit santé, Dieulefit, France.
authors.forename: L
authors.initials: L
authors.lastname: Briota
authors.affiliation: Department of Cardiology, Les Grands Prés (CRCB), Villeneuve St Denis, France Private Hospital Jacques Cartier, Institut cardiovasculaire Paris Sud, Massy, France.
authors.forename: J Y
authors.initials: JY
authors.lastname: Tabet
mesh_terms: D000368:Aged; D006348:Cardiac Surgical Procedures / Q000009:adverse effects; D002305:Cardiac Tamponade / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control; D003078:Colchicine / Q000008:administration & dosage / Q000009:adverse effects; D004311:Double-Blind Method; D016903:Drug Monitoring / Q000379:methods; D004452:Echocardiography / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010490:Pericardial Effusion / Q000175:diagnosis / Q000188:drug therapy / Q000209:etiology / Q000503:physiopathology; D011183:Postoperative Complications / Q000175:diagnosis / Q000188:drug therapy / Q000503:physiopathology; D016896:Treatment Outcome; D050257:Tubulin Modulators / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D050257:Tubulin Modulators; D003078:Colchicine