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Journal of Bone and Joint Surgery - British Volume, Vol 91-B, Issue 5, 636-644.
doi: 10.1302/0301-620X.91B5.21691  
Copyright © 2009 by British Editorial Society of Bone and Joint Surgery
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Oral rivaroxaban for the prevention of symptomatic venous thromboembolism after elective hip and knee replacement

B. I. Eriksson, MD, PhD, Orthopaedic Surgeon1; A. K. Kakkar, MD, PhD, Professor2; A. G. G. Turpie, MD, Professor3; M. Gent, DSc, Professor4; T.-J. Bandel, MD, Clinical Development5; M. Homering, MSPH, Biostatistician5; F. Misselwitz, MD, PhD, Clinical Development5; and M. R. Lassen, MD, Orthopaedic Surgeon6

1 Sahlgrenska University Hospital/Östra, SE-41685 Gothenburg, Sweden.
2 Barts and the London School of Medicine and Dentistry, Turner Street, London E1 2AD, UK.
3 McMaster University, 237 Barton Street East, Hamilton, Ontario L8L 2X2, Canada.
4 Emeritus McMaster University, 1200 Main Street West, Hamilton, Ontario L8N 3Z5, Canada.
5 Bayer Schering Pharma AG, Aprather Weg 42096, Wuppertal, Germany.
6 Hørsholm Hospital, Usserød Kongevej 102, DK-2970, Hørsholm, Denmark.

Correspondence should be sent to Dr B. I. Eriksson; e-mail: b.eriksson{at}orthop.gu.se

A once-daily dose of rivaroxaban 10 mg, an oral, direct Factor Xa inhibitor, was compared with enoxaparin 40 mg subcutaneously once daily for prevention of venous thromboembolism in three studies of patients undergoing elective hip and knee replacement (RECORD programme).

A pooled analysis of data from these studies (n = 9581) showed that rivaroxaban was more effective than enoxaparin in reducing the incidence of the composite of symptomatic venous thromboembolism and all-cause mortality at two weeks (0.4% vs 0.8%, respectively, odds ratio 0.44; 95% confidence interval 0.23 to 0.79; p = 0.005), and at the end of the planned medication period (0.5% vs 1.3%, respectively; odds ratio 0.38; 95% confidence interval 0.22 to 0.62; p < 0.001). The rate of major bleeding was similar at two weeks (0.2% for both) and at the end of the planned medication period (0.3% vs 0.2%).

Rivaroxaban started six to eight hours after surgery was more effective than enoxaparin started the previous evening in preventing symptomatic venous thromboembolism and all-cause mortality, without increasing major bleeding.




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Use of surrogate endpoints in studies of thromboprophylaxis
Robert A E Clayton, et al.
J Bone Joint Surg Br Online, 11 Jun 2009 [Full text]
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Bengt I, Eriksson, et al.
J Bone Joint Surg Br Online, 10 Jul 2009 [Full text]


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Hip, Knee, Trauma, Upper limb, Foot & Ankle, Paediatrics, Oncology, Spine, Arthroplasty, General