International open clinical trial XAMOS — evaluation of the efficiency of rivaroxaban in the prevention of venous thromboembolism (review)

Authors

  • Oleg Vyrva

DOI:

https://doi.org/10.15674/0030-598720143130-135

Keywords:

rivaroxaban, orthopedic practice, thromboprophylaxis

Abstract

Venous thromboembolism (VTE) occupies a leading position in the structure of postoperative morbidity and mortality, especially in patients of orthopedics and trauma profile. The maximal risk is typical for arthroplasty of large joints (40–60 %), for osteosynthesis of massive injuries of musculoskeletal system (40–80 %). Objective: To explore the risk factors of VTE in patients with skeletal injuries and orthopedic disorders, to develop principles of prevention and treatment of thromboembolism on the basis of trial XAMOS for confirmation the efficacy and safety Rivaroksaban in orthopedic practice. Methods: Patients of age 18 years and older whom were prescribed thromboprophylaxis in surgeries for replacement of hip or knee joints from 250 clinical centers in 37 countries were included in this study. There were randomized 17 413 patients, 8778 of whom received Rivaroksaban and 8 635 additionally received other drugs (low molecular weight heparin — 81.7 % fondaparinuks — 7.9 %, dabigatran — 5.5 %, acetylsalicylic acid and vitamin K antagonists — 4.9 %). They studied cases of symptomatic thromboembolism, rare side effects, bleeding and overall mortality. They also evaluated the ease of use, patient consent, use of health care resources, efficiency and safety in selected populations of patients. Results: Cases of symptomatic thromboembolism (arterial and venous) were observed in 78 (0.89 %) patients in Rivaroxaban group, and in 117 (1.35 %) patients in standard therapy group. Symptomatic VTE was detected in 0.65 % of patients in Rivaroxaban group and in 1.02 % in standard therapy group (relative risk reduction of VTE in Rivaroxaban group 37 %). Conclusions: According to trial XAMOS Rivaroxaban comparing with other low molecular weight heparin provides a lower frequency of symptomatic thromboembolism without increasing the risk of massive bleeding and other severe side effects, significantly reduces the incidence of thrombocytopenia, provides ease of use, and minimizes loading on nursing stuff.

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How to Cite

Vyrva, O. (2014). International open clinical trial XAMOS — evaluation of the efficiency of rivaroxaban in the prevention of venous thromboembolism (review). ORTHOPAEDICS TRAUMATOLOGY and PROSTHETICS, (3), 130–135. https://doi.org/10.15674/0030-598720143130-135

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Section

DIGESTS AND REVIEWS