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October 1, 2005Journal of Bone and Joint Surgery

Oral Direct Thrombin Inhibitor Ximelagatran Compared with Warfarin for the Prevention of Venous Thromboembolism After Total Knee Arthroplasty

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Why the study?

Does ximelagatran reduce venous thromboembolism and death compared to warfarin in patients undergoing total knee arthroplasty?

Population

Patients undergoing total knee arthroplasty (n=1,949 in efficacy population)

Comparison

Fixed-dose oral ximelagatran started the morning… vs Warfarin initiated on the evening of the day of…

Design

RCT, Randomly assigned, Double-blind, double-dummy design

Follow-up

7 to 12 days

Authors

CCClifford W. ColwellJr.Scripps Clinic

Discussion

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Implication

Ximelagatran outperforms warfarin for VTE prevention after TKA; extends oral options without monitoring.

Structured PICO

Does ximelagatran reduce venous thromboembolism and death compared to warfarin in patients undergoing total knee arthroplasty?

P
Population
Patients undergoing total knee arthroplasty (n=1,949 in efficacy population)
I
Intervention
Fixed-dose oral ximelagatran (36 mg twice daily) started the morning after surgery, administered for 7 to 12 days
C
Comparator
Warfarin (target international normalized ratio, 2.5) initiated on the evening of the day of surgery, administered for 7 to 12 days
O
Outcome
Composite of asymptomatic deep-vein thrombosis determined by bilateral venography, objectively confirmed symptomatic deep-vein thrombosis or pulmonary embolism, and death from all causes during treatmentcomposite

Oral ximelagatran demonstrated superior efficacy compared with warfarin for preventing venous thromboembolism after total knee arthroplasty, without a statistically significant increase in major bleeding.

Cite This Study

Clifford W. ColwellJr. (2005) studied this question.

synapsesocial.com/papers/6a1553b09b87f33fc69f73afhttps://doi.org/10.2106/jbjs.d.02184

Topics

Pulmonary embolismAnticoagulation in AF
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Also Consider

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

  1. 1Direct thrombin inhibitor melagatran followed by oral ximelagatran in comparison with enoxaparin for prevention of venous thromboembolism after total hip or knee replacement2003 · 252 citations
  2. 2Prevention of Venous Thromboembolism after Knee Arthroplasty1996 · 234 citations
  3. 3A Comparison of Subcutaneous Low-Molecular-Weight Heparin with Warfarin Sodium for Prophylaxis against Deep-Vein Thrombosis after Hip or Knee Implantation1993 · 440 citations
  4. 4Fondaparinux Compared with Enoxaparin for the Prevention of Venous Thromboembolism after Elective Major Knee Surgery2001 · 667 citations
  5. 5The Incidence of Symptomatic Venous Thromboembolism During and After Prophylaxis With Enoxaparin<subtitle>A Multi-institutional Cohort Study of Patients Who Underwent Hip or Knee Arthroplasty</subtitle>1998 · 181 citations