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AVE5026, a new hemisynthetic ultra-low-molecular-weight heparin for the prevention of venous thromboembolism in patients after total knee replacement surgery--TREK: a dose-ranging study

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  1. Plasma levels of mannose-binding lectin and future risk of venous thromboembolism

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  2. Towards patient-specific management of trauma hemorrhage: the effect of resuscitation therapy on parameters of thromboelastometry

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  3. Recommendations on thromboprophylaxis in major joint arthroplasty - many guidelines, little consensus?

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  4. Filaggrin loss-of-function mutations as risk factors for ischemic stroke in the general population

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  1. Rivaroxaban for Thromboprophylaxis After Nonelective Orthopedic Trauma Surgery in Switzerland

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  2. Rivaroxaban for the prevention of venous thromboembolism after hip or knee arthroplasty. Pooled analysis of four studies

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  3. Assessment of HIT Antibody Complex in Hip Fracture Patients Receiving Enoxaparin or Unfractionated Heparin

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  • M R Lassen
  • O E Dahl
  • P Mismetti
  • D Destrée
  • A G G Turpie
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BACKGROUND: AVE5026 is a new hemisynthetic ultra-low-molecular-weight heparin, with a novel anti-thrombotic profile resulting from high anti-factor (F)Xa activity and residual anti-FIIa activity. AVE5026 is in clinical development for venous thromboembolism (VTE) prevention, a frequent complication after total knee replacement (TKR) surgery. OBJECTIVES: This study evaluated the dose-response of AVE5026 for the prevention of VTE in patients undergoing TKR surgery. PATIENTS/METHODS: In this parallel-group, double-blind, double-dummy study, 690 patients were randomized, and 678 treated with once-daily doses of AVE5026 (5, 10, 20, 40, or 60 mg) or enoxaparin 40 mg in the calibrator arm. The primary efficacy end point was VTE until post-operative day 11, defined as deep vein thrombosis (DVT) detected by bilateral venography, symptomatic DVT, non-fatal pulmonary embolism (PE) and VTE-related death. The primary safety outcome was the incidence of major bleeding. RESULTS: The primary efficacy outcome was assessed in 464 patients. There was a significant dose-response across the five AVE5026 groups for VTE prevention (P<0.0001), with the incidence of VTE ranging from 5.3% to 44.1% compared with 35.8% in the enoxaparin group and for proximal DVT (P=0.0002). Also, a significant dose-response for AVE5026 was seen for major bleeding (P=0.0231) and any bleeding (P=0.0003). Six patients in the AVE5026 groups, four in the 60 mg group, experienced major bleeding; none did in the enoxaparin group. CONCLUSIONS: The safety and efficacy results of this study suggest that a AVE5026 dose of between 20 and 40 mg presents an adequate benefit-to-risk ratio.
Original languageEnglish
JournalJournal of Thrombosis and Haemostasis
Volume7
Issue number4
Pages (from-to)566-72
Number of pages6
ISSN1538-7933
DOIs
Publication statusPublished - 2009

Bibliographical note

Keywords: Adult; Aged; Aged, 80 and over; Arthroplasty, Replacement, Knee; Dose-Response Relationship, Drug; Double-Blind Method; Female; Hemorrhage; Heparin; Heparin, Low-Molecular-Weight; Humans; Male; Middle Aged; Postoperative Complications; Premedication; Risk Assessment; Venous Thromboembolism

ID: 171922