Study of rivaroxaban for venous thromboembolism prophylaxis after lower extremity fractures in Russian clinical practice


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Abstract

The purpose of the study was to evaluate the efficacy and safety of rivaroxaban in patients after surgical treatment for the lower extremity fractures. Patients and methods. Retrospective multicenter study included 663 patients with femur fractures, 43 patients with complications after total hip arthroplasty (periprosthetic femur fractures, recurrent dislocation) and 10 patients with shinbone fractures. The majority (81.99%) of patients were elderly or senile. In postoperative period all patients received a standard prophylactic dose of anticoagulants. Out of them 75 (main group) - rivaroxaban (10 mg/day), 241 (control group) - other drugs (enoxaparin - 40 mg/day and dabigatran etexilate 150 or 220 mg/day). The efficacy of prophylaxis was assessed by clinical picture and Doppler ultrasound scans. Results. Average bed day made up 9.28. During hospitalization no cases of PE were recorded. In the main and control groups the rate of deep vein thrombosis with clinical manifestations made up 1.89 and 3.31%, respectively. No cases of fatal bleeding occurred. Signs of continuous bleeding in the area of surgical intervention (soaking dressings or recurring wound hematomas) in the main group was recorded rarely (3.15%) than in the control one (8.29%). Conclusion. Reduction of VTE rate with no increase in bleeding risk indicates the feasibility of rivaroxaban use for postoperative PE prophylaxis in patients with lower extremity fractures.

About the authors

Mikhail V. Belov

Yaroslavl State Medical University

Email: micbelov@yandex.ru
Cand. med. sci., Head of orthopaedic department; assistant professor, chair of traumatology and orthopaedics Yaroslavl’, Russia

References

  1. Lapidus L., Ponzer S., Pettersson H., de Bri E. et al. Symptomatic venous thromboembolism and mortality in orthopaedic surgery - an observational study of 45 968 consecutive procedures. BMC Musculoskelet Disord. 2013; 14: 177. doi: 10.1186/1471-2474-14-177.
  2. Российские клинические рекомендации «Профилактика венозных тромбоэмболических осложнений в травматологии и ортопедии». Травматология и ортопедия России. 2012; 1 (приложение): 2-24.
  3. Jameson S.S., Augustine A., James P. et al. Venous thromboembolic events following foot and ankle surgery in the English National Health Service. J. Bone Joint Surg. Br. 2011; 93 (4): 490-7. doi: 10.1302/0301-620X.93B4.25731.
  4. Geerts W.H., Bergqvist D., Pineo G.F. et al. Prevention of venous thromboembolism: American College of Chest Physicians evidence-based clinical practice guidelines (8th ed). Chest. 2008; 133 (6 suppl): 381S-453S.
  5. Eriksson B.I., Borris L.C., Friedman R.J. et al.; RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N. Engl. J. Med. 2008; 358 (26): 2765-75. doi: 10.1056/NEJMoa0800374.
  6. Kakkar A.K., Brenner B., Dahl O.E. et al.; RECORD2 Investigators. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet. 2008; 372 (9632): 31-9. doi: 10.1016/S0140-6736(08)60880-6.
  7. Lassen M.R., Ageno W., Borris L.C. et al.; RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N. Engl. J. Med. 2008; 358 (26): 2776-86. doi: 10.1056/NEJMoa076016.
  8. Turpie A.G.G., Lassen M.R., Davidson B.L. et al.; RECORD4 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet. 2009; 373 (9676): 1673-80. doi: 10.1016/S0140-6736(09)60734-0.
  9. Eriksson B.I., Dahl O.E., Rosencher N. et al.; RE-NOVATE Study Group. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet. 2007; 370: 949-56.
  10. Eriksson B.E., Dahl O.E., Huo M.H. et al.; RE-NOVATE II Study Group. Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthroplasty (RE-NOVATE II). Thromb. Haemost. 2011; 105: 721-9.
  11. Eriksson B.I., Dahl O.E., Rosencher N. et al.; RE-MODEL Study Group. Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. J. Thromb. Haemost. 2007; 5: 2178-85.
  12. Ginsberg J.S., Davidson B.L., Comp P.C. et al. for the RE-MOBILIZE Writing Committee. Oral thrombin inhibitor dabigatran etexilate vs North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery. J. Arthroplasty. 2009; 24: 1-9.
  13. Lassen M.R., Raskob G.E., Gallus A. et al. Apixaban or enoxaparin for thromboprophylaxis after knee replacement. N. Engl. J. Med. 2009; 361: 594-604.
  14. Lassen M.R., Raskob G.E., Gallus A., Pineo G., Chen D., Hornick P. and the ADVANCE-2 investigators. Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial. Lancet. 2010; 375: 807-15. doi: 10.1016/S0140-6736(09)62125-5.
  15. Lassen M.R., Gallus A., Raskob G.E. et al. for the ADVANCE-3 investigators. Apixaban versus enoxaparin for thromboprophylaxis after hip replacement. N. Engl. J. Med. 2010; 363: 2487-98. doi: 10.1056/NEJMoa1006885.
  16. Lassen M.R., Haas S., Kreutz R. et al. Rivaroxaban for thromboprophylaxis after fracture-related orthopedic surgery in routine clinical practice. Clin. Appl. Thromb. Hemost. 2016; 22 (2): 138-46. doi: 10.1177/1076029615607303.
  17. Balducci L. Epidemiology of anemia in the elderly: information on diagnostic evaluation. J. Am. Geriatr. Soc. 2003; 51 (3 Suppl): S2-S9.
  18. Еськин Н.А., Деркач Е.В., Пядушкина Е.А. Клинико-экономический анализ применения эноксапарина, ривароксабана и дабигатрана для профилактики венозных тромбоэмболий у пациентов после больших ортопедических операций. Вестник травматологии и ортопедии им. Н.Н. Приорова. 2016; 4: 28-33.

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