TB-402 for the prevention of venous thromboembolism in orthopaedic surgery: Something new and promising, or not?

Francesco Dentali; Nicoletta Riva

doi:10.1160/TH13-05-0361

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 2013; 109(06): 977-979
DOI: 10.1160/TH13-05-0361

Invited Editorial Focus

Schattauer GmbH

TB-402 for the prevention of venous thromboembolism in orthopaedic surgery: Something new and promising, or not?

Francesco Dentali

¹Research Center On Thromboembolic Disorders and Antithrombotic Therapies, Department of Clinical and Experimental Medicine, University of Insubria, Varese, Italy

,

Nicoletta Riva

¹Research Center On Thromboembolic Disorders and Antithrombotic Therapies, Department of Clinical and Experimental Medicine, University of Insubria, Varese, Italy

› Author Affiliations

Abstract

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References

References
1 Kyrle PA, Eichinger S. Clinical scores to predict recurrence risk of venous thromboembolism. Thromb Haemost 2012; 108: 1061-1064.
2 Spyropoulos AC, McGinn T, Khorana AA. The use of weighted and scored risk assessment models for venous thromboembolism. Thromb Haemost 2012; 108: 1072-1076.
3 Ageno W, Spyropoulos AC, Turpie AG. Role of new anticoagulants for the prevention of venous thromboembolism after major orthopaedic surgery and in hospitalised acutely ill medical patients. Thromb Haemost 2012; 107: 1027-1034.
4 Falck-Ytter Y, Francis CW, Johanson NA. et al. American College of Chest Physicians. Prevention of VTE in orthopedic surgery patients: Anti-thrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141 (Suppl. 02) e278S-e325S.
5 Emmerechts J, Vanassche T, Loyen S. et al. Partial versus complete factor VIII inhibition in a mouse model of venous thrombosis. Thromb Res 2012; 129: 514-519.
6 Verhamme P, Pakola S, Jensen TJ. et al. Tolerability and pharmacokinetics of TB-402 in healthy male volunteers. Clin Ther 2010; 32: 1205-1220.
7 Tangelder M, Long C, Emmerechts J. et al. Antidote strategies to reverse anticoagulation with TB-402, a long-acting partial inhibitor of factor VIII. J Thromb Haemost 2012; 10: 1371-1378.
8 Verhamme P, Tangelder M, Verhaeghe R. et al. TB-402 Study Group. Single intravenous administration of TB-402 for the prophylaxis of venous thromboembolism after total knee replacement: a dose-escalating, randomized, controlled trial. J Thromb Haemost 2011; 09: 664-671.
9 Verhamme P, Gunn S, Sonesson E. et al. Single-dose TB-402 or Rivaroxaban for the Prevention of Venous Thromboembolism after Total Hip Replacement: A Randomised, Controlled Trial. Thromb Haemost 2013; 109: 1091-1098.
10 Schulz KF, Grimes DA. Blinding in randomised trials: hiding who got what. Lancet 2002; 359: 696-700.
11 O’Neil WM, Welner SA, Lip GY. Do open label blinded outcome studies of novel anticoagulants versus warfarin have equivalent validity to those carried out under double-blind conditions?. Thromb Haemost 2013; 109: 497-503.
12 Eriksson BI, Borris LC, Friedman RJ. et al. REC-ORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med 2008; 358: 2765-2775.
13 Kakkar AK, Brenner B, Dahl OE. et al. RECORD2 Investigators. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthro-plasty: a double-blind, randomised controlled trial. Lancet 2008; 372: 31-39.
14 Lassen MR, Ageno W, Borris LC. et al. RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med 2008; 358: 2776-2786.
15 Turpie AG, Lassen MR, Davidson BL. et al. REC-ORD4 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet 2009; 373: 1673-1680.
16 Turpie AG, Lassen MR, Eriksson BI. et al. Riva-roxaban for the prevention of venous thromboembolism after hip or knee arthroplasty. Pooled analysis of four studies. Thromb Haemost 2011; 105: 444-453.
17 Raskob GE, Hirsh J. Controversies in timing of the first dose of anticoagulant prophylaxis against venous thromboembolism after major orthopedic surgery. Chest 2003; 124 (Suppl. 06) 379S-385S.
18 Strebel N, Prins M, Agnelli G. et al. Preoperative or postoperative start of prophylaxis for venous thromboembolism with low-molecular-weight heparin in elective hip surgery?. Arch Intern Med 2002; 162: 1451-1456.
19 Kamphuisen PW, Eikenboom JC, Bertina RM. Elevated factor VIII levels and the risk of thrombosis. Arterioscler Thromb Vasc Biol 2001; 21: 731-738.