To study the efficacy and safety of Rivaroxaban in the prevention of venous thromboembolism after Total Hip and Knee Arthroplasty

Vol 3 | Issue 2 | Sep-Dec 2017 | page: 3-7 | S. K. Rai, V. P. Raman, Naveen Shejale, S. S. Wani, Rohit Varma


Author: S. K. Rai [1], V. P. Raman [2], Naveen Shejale[3], S. S. Wani [1], Rohit Varma [1].

[1]Department of Orthopaedics, Indian Naval Hospital Ship Asvini, Colaba, Mumbai, 400005, India.
[2]Malla Reddy Institute of Medical Sciences, Suraram, Hyderabad, 500055, India.
[3]Department of Orthopaedics, Indian Naval Hospital Ship Kalyani, Visakhapatnam, 530005, India.

Address of Correspondence
Dr. SK Rai
Department of Orthopaedics, Indian Naval Hospital Ship Asvini, Colaba, Mumbai, 400005, India.
Email: skrai47@yahoo.com


Learning Points for this Article: To prevent of venous thromboembolism after total Hip and Knee Arthroplasty there is parenteral low molecular weight heparin is available and being used in many centers but it has to be given my trained paramedic or nurse however oral drug like Rivaroxaban in once daily doses and it is patients friendly and can be taken at home after discharge. It is safe and as effective as parenteral low molecular weight heparin.


Abstract

Objective: Development of venous thrombo-embolism (VTE) including deep venous thrombosis (DVT) is a common complication after total hip and total knee Arthroplasty, pelvic fracture or long bone fractures especially in the lower limb. Currently used drugs for DVT prophylaxis after these procedures have important limitations, including parenteral administration, and unpredictable plasma levels requiring frequent monitoring and dose adjustment leading to decreased patient compliance. In our study we used oral rivaroxaban, which is one of the newer oral anticoagulants and is a direct factor Xa inhibitor that has demonstrated superior efficacy, compared to that of enoxaparin or any parenteral low molecular weight heparin (LMWH).
Materials and Methods: In our study, 180 patients who underwent Total knee replacement (TKR) or Total hip replacement (THR) in our center were included. They were put on oral rivaroxaban, 10 mg once daily, started 6 h after surgery and continued for 3 weeks in case of TKR and 6 weeks in case of THR.
Results: VTE and DVT are common complications after THR and TKR and cause a substantial burden to patients, healthcare providers, increase costs to the patients and increase both morbidity and mortality, if not addressed promptly. Currently available anticoagulants in the form of subcutaneous injection have limitations that lead to decreased compliance with DVT prophylaxis guidelines. Rivaroxaban which is oral 10 mg once daily has superior efficacy compared to enoxaparin or any parenteral LMWH for the prevention of the same and the patient compliance is also very good. There were no incidences of increased bleeding or wound infection in our study as compared to control group which were given subcutaneous enoxaparin.
Keywords: Venous thrombo-embolism, deep vein thrombosis, Total knee replacement, Total hip replacement, Rivaroxaban, deep venous thrombosis prophylaxis.


References

1. Kucher N. Clinical practice. Deep-vein thrombosis of the upper extremities. N Engl J Med. 2011;364:861–869. [PubMed]
2. Ciccone WJ, II, Fox PS, Neumyer M, Rubens D, Parrish WM, Pellegrini VD., Jr Ultrasound surveillance for asymptomatic deep venous thrombosis after total joint replacement. J Bone Joint Surg Am. 1998;80:1167–74. [PubMed].
3. Selby R, Borah BJ, McDonald HP, Henk HJ, Crowther M, Wells PS. Impact of thrombo-prophylaxis guidelines on clinical outcomes following total hip and total knee replacement. Thromb Res. 2012;130(2):166–72. [PubMed].
4. Prevention of venous thrombosis and pulmonary embolism. NIH Consensus Development. JAMA. 1986;256:744–749. [PubMed].
5. Cohen AT. Asia-Pacific Thrombosis Advisory Board. Asia-Pacific Thrombosis Advisory Board consensus paper on prevention of venous thromboembolism after major orthopaedic surgery. Thromb Haemost. 2010;104:919–930. [PubMed].
6. Piovella F, Wang CJ, Lu H, Lee K, Lee LH, Lee WC, et al. Deep-vein thrombosis rates after major orthopedic surgery in Asia. An epidemiological study based on postoperative screening with centrally adjudicated bilateral venography. J Thromb Haemost. 2005;3:2664–2670. [PubMed]
7. Januel JM, Chen G, Ruffieux C, Quan H, Douketis JD, Crowther MA, et al. Symptomatic in-hospital deep vein thrombosis and pulmonary embolism following hip and knee arthroplasty among patients receiving recommended prophylaxis: a systematic review. JAMA. 2012;307:294–303. [PubMed]
8. Eikelboom JW, Karthikeyan G, Fagel N, Hirsh J. American Association of Orthopedic Surgeons and American College of Chest Physicians guidelines for venous thromboembolism prevention in hip and knee arthroplasty differ: what are the implications for clinicians and patients? Chest. 2009;135:513–520. [PubMed]
9. D. Kubitza, M. Becka, W. Mueck et al., “Effects of renal impairment on the pharmacokinetics, pharmacodynamics and safety of rivaroxaban, an oral, direct Factor Xa inhibitor,” British Journal of Clinical Pharmacology, vol. 70, no. 5, pp. 703–712, 2010.
10. Geerts WH, Bergqvist D, Pineo GF, Heit JA, Samama CM, Lassen MR, et al. Prevention of venous thromboembolism: American College of Chest Physicians evidence-based clinical practice guidelines (8th Edition) Chest. 2008;133(6 Suppl):381S–453S. doi: 10.1378/chest.08-0656 . [PubMed]
11. Kim YH, Oh SH, Kim JS. Incidence and natural history of deep-vein thrombosis after total hip arthroplasty. A prospective and randomised clinical study. J Bone Joint Surg Br. 2003;85(5):661–665.[PubMed]
12. Stringer MD, Steadman CA, Hedges AR, Thomas EM, Morley TR, Kakkar VV. Deep vein thrombosis after elective knee surgery. An incidence study in 312 patients. J Bone Joint Surg Br. 1989;71(3):492–497.[PubMed]
13. Fisher CG, Blachut PA, Salvian AJ, Meek RN, O’Brien PJ. Effectiveness of pneumatic leg compression devices for the prevention of thromboembolic disease in orthopaedic trauma patients: a prospective, randomized study of compression alone versus no prophylaxis. J Orthop Trauma. 1995;9(1):1–7. [PubMed]
14. Lachiewicz PF, Kelley SS, Haden LR. Two mechanical devices for prophylaxis of thromboembolism after total knee arthroplasty. A prospective, randomised study. J Bone Joint Surg Br. 2004;86(8):1137–1141.[PubMed]
15. Hull R, Raskob G, Pineo G, Rosenbloom D, Evans W, Mallory T, et al. A comparison of subcutaneous low-molecular-weight heparin with warfarin sodium for prophylaxis against deep-vein thrombosis after hip or knee implantation. N Engl J Med. 1993;329(19):1370–1376. [PubMed]
16. Hull RD, Pineo GF, Francis C, Bergqvist D, Fellenius C, Soderberg K, et al. Low-molecular-weight heparin prophylaxis using dalteparin extended out-ofhospital vs in-hospital warfarin/out-of-hospital placebo in hip arthroplasty patients: a doubleblind, randomized comparison. North American Fragmin Trial Investigators. Arch Intern Med. 2000;160(14):2208–2215. [PubMed]
17. Stewart DW, Freshour JE. Aspirin for the prophylaxis of venous thromboembolic events in orthopedic surgery patients: a comparison of the AAOS and ACCP guidelines with review of the evidence. Ann Pharmacother. 2013;47(1):63–74. [PubMed]
18. Palmer AJ, Koppenhagen K, Kirchhof B, Weber U, Bergemann R. Efficacy and safety of low molecular weight heparin, unfractionated heparin and warfarin for thrombo-embolism prophylaxis in orthopaedic surgery: a meta-analysis of randomised clinical trials. Haemostasis. 1997;27(2):75–84. [PubMed]
19. Mont MA, Jacobs JJ. AAOS clinical practice guideline: preventing venous thromboembolic disease in patients undergoing elective hip and knee arthroplasty. [[cited 2014 Jan 19]];J Am Acad Orthop Surg. 2011 Dec 19(12):777–8. [Internet] Available from: http://www.ncbi.nlm.nih.gov/pubmed/22134210 . [PubMed]
20. Lassen MR, Gallus A, Raskob GE, Pineo G, Chen D, Ramirez LM. Apixaban versus enoxaparin for thromboprophylaxis after hip replacement. N Engl J Med. 2010;363(26):2487–2498. [PubMed]
21. Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, et al. 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(11):2178–2185. [PubMed]
22. Eriksson BI, Borris LC, Friedman RJ, Haas S, Huisman MV, Kakkar AK, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008;358(26):2765–2775.[PubMed].
23. Jameson SS, Rymaszewska M, Hui ACW, James P, Serrano-Pedraza I, Muller SD. Wound complications following rivaroxaban administration: a multicenter comparison with low-molecular-weight heparins for thromboprophylaxis in lower limb arthroplasty. J Bone Joint Surg Am. 2012;94(17):1554–1558. [PubMed].


How to Cite this article: Rai S K, Raman V P, Shejale N, Wani S S, Varma R. To study the efficacy and safety of Rivaroxaban in the prevention of venous thromboembolism after Total Hip and Knee Arthroplasty. Trauma International Sep – Dec 2017;3(2):3-7.


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