Safety of prothrombin complex concentrates for rapid anticoagulation reversal of vitamin K antagonists
- 1 January 2011
- journal article
- research article
- Published by Georg Thieme Verlag KG in Thrombosis and Haemostasis
- Vol. 106 (09), 429-438
- https://doi.org/10.1160/th11-01-0052
Abstract
Prothrombin complex concentrates (PCCs) are recommended as the treatment of choice in warfarin-related coagulopathy. However, the risk of thromboembolic complications associated with their use is not well defined. We performed a meta-analysis to estimate the rate of thromboembolic complications in patients receiving vitamin K antagonists (VKAs) treated with PCCs for bleeding or before urgent surgery. Medline and Embase databases were searched. Two reviewers performed study selection and extracted data independently. Studies providing data on incidence of thromboembolic complications in VKA-treated patients were eligible for the study. Weighted mean proportion of the rate of thromboembolic complications and the mortality rate were calculated. Twenty-seven studies (1,032 patients) were included. Seven studies used 3-factor, and 20 4-factor PCCs. Twelve patients had a thromboembolic complication (weighted mean 1.4%; 95% CI 0.8–2.1), of which two were fatal. The incidence of thromboembolic events was 1.8% (95% CI 1.0–3.0) in patients treated with 4-factor PCCs, and 0.7% (95% CI 0.0–2.4) in patients treated with 3-factor PCCs. Total mortality rate was 10.6% (95% CI 5.9–16.6). In conclusion, our results suggest there is a low but quantifiable risk of thromboembolism in VKA-treated patients receiving PCCs for anticoagulation reversal. These findings should be confirmed in randomised, controlled trials.This publication has 47 references indexed in Scilit:
- Safety of Recombinant Activated Factor VII in Randomized Clinical TrialsThe New England Journal of Medicine, 2010
- Prothrombin complex concentrate in surgical patients: retrospective evaluation of vitamin K antagonist reversal and treatment of severe bleedingCritical Care, 2009
- Prevention and treatment of bleeding complications in patients receiving vitamin K antagonists, part 2: TreatmentAmerican Journal of Hematology, 2009
- Pharmacology and Management of the Vitamin K Antagonists: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition)Social psychiatry. Sozialpsychiatrie. Psychiatrie sociale, 2008
- Prothrombin complex concentrate (Beriplex P/N) in severe bleeding: experience in a large tertiary hospitalCritical Care, 2008
- Bleeding Complications With Warfarin UseArchives of Internal Medicine, 2007
- Measuring inconsistency in meta-analysesBMJ, 2003
- Prothrombin complex concentrate for oral anticoagulant reversal in neurosurgical emergenciesBritish Journal of Neurosurgery, 2000
- Emergency reversal of anticoagulation after intracerebral hemorrhage.Stroke, 1992
- Comparison of prothrombin complex concentrate and vitamin K1 in oral anticoagulant reversal.BMJ, 1976