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01-01-2005 | Original Research Article

Postoperative Melagatran/ Ximelagatran for the Prevention of Venous Thromboembolism following Major Elective Orthopaedic Surgery

Effects of Timing of First Dose and Risk Factors for Thromboembolism and Bleeding Complications on Efficacy and Safety

Authors: Dr Ola E. Dahl, Bengt I. Eriksson, Giancarlo Agnelli, Alexander T. Cohen, Patrick Mouret, Nadia Rosencher, Seva Panfilov, Anders Bylock, Magnus Andersson

Published in: Clinical Drug Investigation | Issue 1/2005

Abstract

Objectives: To examine the influence of timing of postoperative initiation of subcutaneous melagatran followed by oral ximelagatran, and of risk factors for venous thromboembolism (VTE; including deep vein thrombosis [DVT] and pulmonary embolism [PE]) and bleeding complications, on the efficacy and safety of this regimen, compared with preoperative enoxaparin sodium, following total hip replacement (THR) or total knee replacement (TKR) surgery.

Design: Statistical analyses of efficacy and safety in subgroups of the METHRO III intention-to-treat population.

Main outcome measures: Main efficacy outcome measures were major VTE (proximal DVT, PE or VTE-related death) and total VTE (distal or proximal DVT, fatal or non-fatal PE). The main safety outcome measures were blood transfusion, severe bleeding events, blood loss, bleeding-related adverse events and need for reoperation.

Results: In the combined THR and TKR population, melagatran initiated 4–<8 hours postoperatively was non-inferior to enoxaparin sodium with respect to the risks of total VTE (absolute risk reduction [ARR] 0; 95% confidence interval [CI] ∼-4.4, 4.4) and major VTE (ARR −0.63; 95% CI −2.94, 1.67). The rate of major VTE was unaffected by the different risk factors. In the combined THR and TKR population, blood transfusion requirements were lower with melagatran/ximela-gatran than enoxaparin sodium (odds ratio 0.83; 95% CI 0.71, 0.96; p = 0.016).

Conclusions: Melagatran/ximelagatran initiated 4–<8 hours postoperatively provided a comparable level of protection against total and major VTE to preoperative enoxaparin sodium. Major VTE rates and safety were consistent across different patient subgroups. Subcutaneous melagatran followed by fixed-dose oral ximelagatran offers an alternative to the standard European low molecular-weight heparin regimen in a wide range of patients.

The use of trade names is for product identification purposes only and does not imply endorsement.

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Title: Postoperative Melagatran/ Ximelagatran for the Prevention of Venous Thromboembolism following Major Elective Orthopaedic Surgery
Effects of Timing of First Dose and Risk Factors for Thromboembolism and Bleeding Complications on Efficacy and Safety
Authors: Dr Ola E. Dahl
Bengt I. Eriksson
Giancarlo Agnelli
Alexander T. Cohen
Patrick Mouret
Nadia Rosencher
Seva Panfilov
Anders Bylock
Magnus Andersson
Publication date: 01-01-2005
Publisher: Springer International Publishing
Published in: Clinical Drug Investigation / Issue 1/2005
Print ISSN: 1173-2563
Electronic ISSN: 1179-1918
DOI: https://doi.org/10.2165/00044011-200525010-00006

Keynote webinar | Spotlight on medication adherence

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Postoperative Melagatran/ Ximelagatran for the Prevention of Venous Thromboembolism following Major Elective Orthopaedic Surgery

Effects of Timing of First Dose and Risk Factors for Thromboembolism and Bleeding Complications on Efficacy and Safety

Abstract

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

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