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January 1, 2002Thrombosis and Haemostasis

A Dose-ranging Study of the Oral Direct Thrombin Inhibitor, Ximelagatran, and Its Subcutaneous Form, Melagatran, Compared with Dalteparin in the Prophylaxis of Thromboembolism after Hip or Knee Replacement: METHRO I

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Why the study?

Does sequential subcutaneous melagatran and oral ximelagatran prevent deep vein thrombosis compared to dalteparin in patients undergoing elective total hip or knee replacement?

Population

136 patients scheduled for elective total hip or total knee replacement

Comparison

Subcutaneous melagatran for 2 days commencing… vs Dalteparin 5000 IU subcutaneous once daily…

Design

RCT, randomized, parallel-group

Follow-up

8-11 days

Authors

AAAnn-Christin ArfwidssonAstraZeneca (United Kingdom)LFLars FrisonAstraZeneca (Sweden)UEUlf G. ErikssonAstraZeneca (Sweden)

Discussion

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Implication

Melagatran/ximelagatran yields similar DVT rates to dalteparin; extends oral direct thrombin inhibition for post-orthopedic VTE prophylaxis.

Structured PICO

Does sequential subcutaneous melagatran and oral ximelagatran prevent deep vein thrombosis compared to dalteparin in patients undergoing elective total hip or knee replacement?

P
Population
136 patients scheduled for elective total hip or total knee replacement
I
Intervention
Subcutaneous melagatran (1, 2 or 4 mg bid) for 2 days commencing immediately before surgery, followed by oral ximelagatran (6, 12 or 24 mg bid) for 6-9 days
C
Comparator
Dalteparin 5000 IU subcutaneous once daily, started the evening before surgery, for 8-11 days
O
Outcome
Deep vein thrombosis assessed by bilateral venographyhard clinical

In this first clinical study, sequential subcutaneous melagatran and oral ximelagatran demonstrated similar rates of deep vein thrombosis and bleeding compared to dalteparin for VTE prophylaxis after orthopedic surgery.

Limitations

  • The study did not evaluate a dose-response for efficacy

Cite This Study

Arfwidsson et al. (2002) studied this question.

synapsesocial.com/papers/6a7100cce71d69abee08fcb4https://doi.org/10.1055/s-0037-1612978
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Ximelagatran in Orthopaedic Surgery2005 · 6 citations
  2. 2Ximelagatran: An orally active direct thrombin inhibitor2005 · 23 citations
  3. 3Oral Thrombin Inhibitor Ximelagatran2004
  4. 4Direct thrombin inhibitor melagatran followed by oral ximelagatran in comparison with enoxaparin for prevention of venous thromboembolism after total hip or knee replacement2003 · 252 citations
  5. 5Oral Direct Thrombin Inhibitor Ximelagatran Compared with Warfarin for the Prevention of Venous Thromboembolism After Total Knee Arthroplasty2005 · 74 citations