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Rivaroxaban for venous thromboembolism prevention after major orthopedic surgery: translating trial data into routine clinical practice

Authors Beyer-Westendorf J, Mouret P, Turpie AGG

Received 28 January 2016

Accepted for publication 31 May 2016

Published 31 January 2017 Volume 2017:9 Pages 1—11

DOI https://doi.org/10.2147/ORR.S105227

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Lucy Goodman

Peer reviewer comments 2

Editor who approved publication: Professor Clark Hung


Jan Beyer-Westendorf,1 Patrick Mouret,2 Alexander GG Turpie3

1Thrombosis Research and Angiology, Dresden University Clinic, Dresden, Germany; 2Orthopedic Clinic, Klinikum Frankfurt Höchst GmbH, Frankfurt, Germany; 3Department of Medicine, General Division, Hamilton Health Sciences, Hamilton, ON, Canada

Abstract: An established standard of care for the prevention of venous thromboembolism after major orthopedic surgery has been subcutaneous low-molecular-weight heparin. The non-vitamin K antagonist oral anticoagulant rivaroxaban has demonstrated superior efficacy and similar safety to all tested regimens of enoxaparin in large Phase III clinical studies of venous thromboembolism prevention after elective hip and knee arthroplasty. Despite regulatory approval of rivaroxaban for this indication, concerns remain among physicians regarding its optimal and effective use in routine clinical practice. Real-life studies, such as XAMOS and ORTHO-TEP, are providing physicians with more information on the routine use of rivaroxaban for venous thromboembolism prevention after orthopedic surgery, helping to establish its safety and effectiveness in everyday clinical care. Among the most important issues are the risk of bleeding complications, wound healing, timing of first dose, impact of type of anesthesia on thromboprophylaxis effectiveness, patient comorbidities and comedication use, periprocedural management, associated costs, and clinical outcomes in trauma-related fractures. Many of these issues are difficult to study in randomized, double-blind, Phase III trials, and can be assessed more readily using real-life data. In particular, real-life or noninterventional studies lack many of the strict inclusion and exclusion criteria associated with Phase III trials and involve unselected patients who often present with significant comorbidities or comedication use.

Keywords: anticoagulants, arthroplasty, orthopedics, rivaroxaban, thrombosis

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