Abstract | OBJECTIVES: 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: CLINICAL TRIAL REG NO: NCT01266694.
|
Authors | P Meurin, S Lelay-Kubas, B Pierre, H Pereira, B Pavy, M C Iliou, J L Bussière, H Weber, J P Beugin, T Farrokhi, A Bellemain-Appaix, L Briota, J Y Tabet, French Society of Cardiology |
Journal | Heart (British Cardiac Society)
(Heart)
Vol. 101
Issue 21
Pg. 1711-6
(Nov 2015)
ISSN: 1468-201X [Electronic] England |
PMID | 26076938
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
|
Copyright | 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. |
Chemical References |
- Tubulin Modulators
- Colchicine
|
Topics |
- Aged
- Cardiac Surgical Procedures
(adverse effects)
- Cardiac Tamponade
(diagnosis, etiology, prevention & control)
- Colchicine
(administration & dosage, adverse effects)
- Double-Blind Method
- Drug Monitoring
(methods)
- Echocardiography
(methods)
- Female
- Humans
- Male
- Middle Aged
- Pericardial Effusion
(diagnosis, drug therapy, etiology, physiopathology)
- Postoperative Complications
(diagnosis, drug therapy, physiopathology)
- Treatment Outcome
- Tubulin Modulators
(administration & dosage, adverse effects)
|