P Meurin1, S Lelay-Kubas2, B Pierre3, H Pereira4, B Pavy5, M C Iliou6, J L Bussière7, H Weber1, J P Beugin8, T Farrokhi9, A Bellemain-Appaix10, L Briota11, J Y Tabet12. 1. Department of Cardiology, Les Grands Prés (CRCB), Villeneuve St Denis, France. 2. Centre de Réadaptation Bois Gibert, Ballan Mire, France. 3. IRIS, Marcy l'étoile, France. 4. 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. 5. Centre Hospitalier Loire Vendée Océan, Machecoul, France. 6. Corentin-Celton Hospital, Issy Les Moulineaux, France. 7. Clinique De Chatillon, Châtillon, France. 8. Clinique de la Mitterie 195 rue Adolphe Defrenne, Lomme, France. 9. Bligny Hospital, Briis-sous-Forges, France. 10. La Maison du Mineur, Vence, France. 11. Centre Dieuleufit santé, Dieulefit, France. 12. Department of Cardiology, Les Grands Prés (CRCB), Villeneuve St Denis, France Private Hospital Jacques Cartier, Institut cardiovasculaire Paris Sud, Massy, France.
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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Authors: Spyridon G Deftereos; Frans J Beerkens; Binita Shah; George Giannopoulos; Dimitrios A Vrachatis; Sotiria G Giotaki; Gerasimos Siasos; Johny Nicolas; Clare Arnott; Sanjay Patel; Mark Parsons; Jean-Claude Tardif; Jason C Kovacic; George D Dangas Journal: Circulation Date: 2021-12-29 Impact factor: 29.690