Type of anaesthesia and the safety and efficacy of thromboprophylaxis with enoxaparin or dabigatran etexilate in major orthopaedic surgery: Pooled analysis of three randomized controlled trials

被引：13

作者：

Nadia Rosencher

Herbert Noack

Martin Feuring

Andreas Clemens

Richard J Friedman

Bengt I Eriksson

机构：

[1] Staff Anaesthesiologist, Department of Anaesthesiology and Intensive Care, Paris Descartes University, Cochin Hospital (AP HP), 75014, Paris, rue du Faubourg Saint-Jacques

[2] Medical Data Services, Boehringer Ingelheim Pharma GmbH and Co. KG, Ingelheim am Rhein

[3] Department of Clinical Development and Medical Affairs, Boehringer Ingelheim International GmbH, Ingelheim am Rhein

[4] Department of Orthopaedic Surgery, Roper Hospital, Medical University of South Carolina, Charleston, SC

[5] Department of Orthopaedic Surgery, University of Gothenburg, Sahlgrenska University Hospital, Mölndal

来源：

Thrombosis Journal | / 10卷 / 1期

关键词：

Bleeding; Dabigatran etexilate; Thromboprophylaxis; Type of anaesthesia; Venous thromboembolism;

D O I：

10.1186/1477-9560-10-9

中图分类号：

学科分类号：

摘要：

Background: There has been a shift towards greater use of neuraxial over general anaesthesia for patients undergoing total hip or knee arthroplasty. Furthermore, suggestions that peripheral nerve block may reduce adverse effects have recently been put forward. Although older studies showed a reduction in venous thromboembolism (VTE) with neuraxial compared with general anaesthesia, this difference has not been confirmed in studies using effective current thromboprophylaxis. We used a large data set to investigate the pattern of anaesthesia usage, and whether anaesthesia type affects efficacy and bleeding outcomes of thromboprophylaxis overall, within each treatment group, or for the novel oral anticoagulant dabigatran etexilate versus enoxaparin.Methods: Three previously reported trials compared 220 mg and 150 mg dabigatran etexilate once daily with enoxaparin after knee or hip arthroplasty. A pooled analysis was performed in patients receiving general or neuraxial anaesthesia, or the combination of either with peripheral nerve block (n = 8062). Outcome measures were major VTE plus VTE-related mortality, major bleeding and major plus clinically relevant bleeding events.Results: General, neuraxial and combination anaesthesia were used in 29%, 52% and 19% of patients, respectively. Differences in efficacy and safety between anaesthesia subgroups were small and not significant, except for a slightly higher rate of major VTE and VTE-related mortality with general versus neuraxial anaesthesia (odds ratio: 1.40; 95% confidence interval: 1.03-1.90; p = 0.035) in the overall population. There were no significant effects of anaesthesia type on efficacy or safety of dabigatran etexilate versus enoxaparin.Conclusions: Anaesthesia type did not greatly affect efficacy and safety outcomes in the pooled population of all three treatment groups. The efficacy and safety of dabigatran etexilate was comparable with enoxaparin, regardless of type of anaesthesia.Trial registration: ClinicalTrials.gov identifiers: NCT00168805, NCT00168818, NCT00152971. © 2012 Rosencher et al.; licensee BioMed Central Ltd.

引用

共 28 条

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