International open clinical trial XAMOS — evaluation of the efficiency of rivaroxaban in the prevention of venous thromboembolism (review)
DOI:
https://doi.org/10.15674/0030-598720143130-135Keywords:
rivaroxaban, orthopedic practice, thromboprophylaxisAbstract
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.
References
- A non-interventional comparison of rivaroxaban with standard of care for thromboprophylaxis after major orthopaedic surgery in 17.701 patients with propensity score adjustment / A. G. Turpie, S. Haas, R. Kreutz [et al.] // Thromb. Haemost. — 2014. — Vol. 111. — P. 94–102. DOI: 10.1160/TH13-08-0666.
- Insufficient duration of venous thromboembolism prophylaxis after total hip or knee replacement when compared with the time course of thromboembolic events: findings from the Global Orthopaedic Registry / D. Warwick, R. J. Friedman, G. Agnelli [et al.] // J. Bone Joint Surg. — 2007. — Vol. 89-A. — P. 799–807.
- Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty / B. I. Eriksson, L. C. Borris, R. J. Friedman [et al.] // N. Engl. J. Med. — 2008. — Vol. 358. — P. 2765–2775. DOI: 10.1056/NEJMoa0800374.
- Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial / A. K. Kakkar, B. Brenner, O. E. Dahl [et al.] // Lancet. — 2008. — Vol. 372. — P. 31–39. DOI: 10.1016/S0140-6736(08)60880-6.
- Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty / M. R. Lassen, W. Ageno, L. C. Borris [et al.] // N. Engl. J. Med. — 2008. — Vol. 358. — P. 2776–2786. DOI: 10.1056/NEJMoa076016.
- Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomized trial / A. G. Turpie, M. R. Lassen, B. L. Davidson [et al.] // Lancet. — 2009. — Vol. 373. — P. 1673–1680. DOI: 10.1016/S0140-6736(09)60734-0.
- Rubin D. B. The design versus the analysis of observational studies for causal effects: parallels with the design of randomized trials / D. B. Rubin // Stat. Med. — 2007. — Vol. 26. — P. 20–36.
- Rivaroxaban for the prevention of venous thromboembolism after hip or knee arthroplasty. Pooled analysis of four studies / A. G. Turpie, M. R. Lassen, B. I. Eriksson [et al.] // Thromb. Haemost. — 2011. — Vol. 105. — P. 444–453. DOI: 10.1160/TH10-09-0601.
- European Medicines Agency. Guideline on clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in patients undergoing high VTE-risk surgery.
- Rationale and design of XAMOS: noninterventional study of rivaroxaban for prophylaxis of venous thromboembolism after major hip and knee surgery / A. G. Turpie, A. C. Schmidt, R. Kreutz [et al.] // Vasc. Health Risk Manag. — 2012. — Vol. 8. — P. 363–370. DOI: 10.2147/VHRM.S30064.
- Holland P. W. Statistics and causal inference / P. W. Holland // J. Am. Statistical Assoc. — 1986. — Vol. 81. — P. 945–960.
- Rubin D. B. Estimating causal effects of treatments in randomized and nonrandomized studies / D. B. Rubin // J. Educ. Psychol. — 1974. — Vol. 66. — P. 668–701.
- Rubin D. B. Bayesian inference for causal effects: The role of randomization / D. B. Rubin // Annals of Statistics. — 1978. — Vol. 6. — P. 34–58.
- Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients / S. Schulman, U. Angeras, D. Bergqvist [et al.] // J. Thromb. Haemost. — 2010. — Vol. 8. — P. 202–204. DOI: 10.1111/j.1538-7836.2009.03678.x.
- Weber J. C. P. Epidemiology of adverse reactions to nonsteroidal anti-inflammatory drugs / J. C. P. Weber // Advances in Inflammatory Research. — Raven Press, 1984. — P. 1–7.
- Management consensus guidance for the use of rivaroxaban — an oral, direct Factor Xa inhibitor / A. G. Turpie, R. Kreutz, J. Llau [et al.] // Thromb. Haemost. — 2012. — Vol. 108. — P. 876–886. DOI: 10.1160/TH12-03-0209.
Downloads
How to Cite
Issue
Section
License
Copyright (c) 2014 Oleg Vyrva
This work is licensed under a Creative Commons Attribution 4.0 International License.
The authors retain the right of authorship of their manuscript and pass the journal the right of the first publication of this article, which automatically become available from the date of publication under the terms of Creative Commons Attribution License, which allows others to freely distribute the published manuscript with mandatory linking to authors of the original research and the first publication of this one in this journal.
Authors have the right to enter into a separate supplemental agreement on the additional non-exclusive distribution of manuscript in the form in which it was published by the journal (i.e. to put work in electronic storage of an institution or publish as a part of the book) while maintaining the reference to the first publication of the manuscript in this journal.
The editorial policy of the journal allows authors and encourages manuscript accommodation online (i.e. in storage of an institution or on the personal websites) as before submission of the manuscript to the editorial office, and during its editorial processing because it contributes to productive scientific discussion and positively affects the efficiency and dynamics of the published manuscript citation (see The Effect of Open Access).