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November 16, 2005Blood

Prevention of Venous Thromboembolism after Total Hip Replacement with Once-Daily BAY 59-7939 - An Oral, Direct Factor Xa Inhibitor.

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Why the study?

Does oral BAY 59-7939 prevent venous thromboembolism compared to enoxaparin in patients undergoing elective total hip replacement?

Population

810 males over the age of 18 and postmenopausal females undergoing elective total hip replacement. European…

Comparison

Oral BAY 59-7939 5, 10, 20, 30, or 40 mg once… vs Subcutaneous enoxaparin 40 mg once daily…

Design

RCT, randomized, double-blind, double-dummy

Follow-up

30-60 days after the last study treatment

Authors

BEBengt I. ErikssonKarolinska InstitutetLBLars C. BorrisAarhus University HospitalODOla E. DahlGeneral / Preventive / Lipids

Discussion

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Implication

Rivaroxaban was superior to enoxaparin for VTE prevention after hip replacement with similar bleeding; extends RCT support for oral Factor Xa inhibitors in orthopedic prophylaxis.

Structured PICO

Does oral BAY 59-7939 prevent venous thromboembolism compared to enoxaparin in patients undergoing elective total hip replacement?

P
Population
810 males over the age of 18 and postmenopausal females undergoing elective total hip replacement. European cohort.
I
Intervention
Oral BAY 59-7939 5, 10, 20, 30, or 40 mg once daily, initiated 6-8 hours after surgery and given every 24±2 hours.
C
Comparator
Subcutaneous enoxaparin 40 mg once daily, initiated on the evening before surgery and at least 6-8 hours after surgery.
O
Outcome
Composite of any DVT, objectively confirmed non-fatal pulmonary embolism (PE), and all-cause mortalitycomposite

Cite This Study

Eriksson et al. (2005) studied this question.

synapsesocial.com/papers/6a72714f35aa2c282ce340dchttps://doi.org/10.1182/blood.v106.11.280.280
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Also Consider

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

  1. 1Oral direct factor Xa inhibition with edoxaban for thromboprophylaxis after elective total hip replacement2010 · 147 citations
  2. 2Once Daily YM150, an Oral Direct Factor Xa Inhibitor, for Prevention of Venous Thromboembolism in Patients Undergoing Elective Primary Hip Replacement.2007 · 7 citations
  3. 3Rivaroxaban for thromboprophylaxis after orthopaedic surgery: Pooled analysis of two studies2007 · 76 citations
  4. 4A Synthetic Pentasaccharide for the Prevention of Deep-Vein Thrombosis after Total Hip Replacement2001 · 382 citations
  5. 5Oral rivaroxaban for the prevention of symptomatic venous thromboembolism after elective hip and knee replacement2009 · 182 citations