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Volumn 10, Issue , 2014, Pages 157-167

Benefit-risk assessment of rivaroxaban versus enoxaparin for the prevention of venous thromboembolism after total hip or knee arthroplasty

Author keywords

DVT; PE; Thromboprophylaxis; Total hip arthroplasty; Total knee arthroplasty; VTE

Indexed keywords

ENOXAPARIN; RIVAROXABAN;

EID: 84898017504     PISSN: 11766344     EISSN: 11782048     Source Type: Journal    
DOI: 10.2147/VHRM.S54714     Document Type: Article
Times cited : (29)

References (39)
  • 2
    • 0037704209 scopus 로고    scopus 로고
    • Natural history of venous thromboembolism
    • Kearon C. Natural history of venous thromboembolism. Circulation. 2003;107(23 Suppl 1):I22-I30.
    • (2003) Circulation. , vol.107 , Issue.23 SUPPL. 1
    • Kearon, C.1
  • 3
    • 0037182022 scopus 로고    scopus 로고
    • Effect of postthrombotic syndrome on health-related quality of life after deep venous thrombosis
    • Kahn SR, Hirsch A, Shrier I. Effect of postthrombotic syndrome on health-related quality of life after deep venous thrombosis. Arch Intern Med. 2002;162(10):1144-1148.
    • (2002) Arch Intern Med. , vol.162 , Issue.10 , pp. 1144-1148
    • Kahn, S.R.1    Hirsch, A.2    Shrier, I.3
  • 4
    • 0346688755 scopus 로고    scopus 로고
    • Relationship between deep venous thrombosis and the postthrombotic syndrome
    • Kahn SR, Ginsberg JS. Relationship between deep venous thrombosis and the postthrombotic syndrome. Arch Intern Med. 2004;164(1): 17-26.
    • (2004) Arch Intern Med. , vol.164 , Issue.1 , pp. 17-26
    • Kahn, S.R.1    Ginsberg, J.S.2
  • 5
    • 33748795599 scopus 로고    scopus 로고
    • Risk factors for chronic thromboembolic pulmonary hypertension
    • Lang I, Kerr K. Risk factors for chronic thromboembolic pulmonary hypertension. Proc Am Thorac Soc. 2006;3(7):568-570.
    • (2006) Proc Am Thorac Soc. , vol.3 , Issue.7 , pp. 568-570
    • Lang, I.1    Kerr, K.2
  • 6
    • 2442643903 scopus 로고    scopus 로고
    • Thromboembolic Pulmonary Hypertension Study Group. Incidence of chronic thromboembolic pulmonary hypertension after pulmonary embolism
    • Pengo V, Lensing AWA, Prins MH, etal. Thromboembolic Pulmonary Hypertension Study Group. Incidence of chronic thromboembolic pulmonary hypertension after pulmonary embolism. N Engl J Med. 2004;350(22):2257-2264.
    • (2004) N Engl J Med. , vol.350 , Issue.22 , pp. 2257-2264
    • Pengo, V.1    Lensing, A.W.A.2    Prins, M.H.3
  • 7
    • 60249096578 scopus 로고    scopus 로고
    • 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?
    • 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(2):513-520.
    • (2009) Chest. , vol.135 , Issue.2 , pp. 513-520
    • Eikelboom, J.W.1    Karthikeyan, G.2    Fagel, N.3    Hirsh, J.4
  • 8
    • 84856797169 scopus 로고    scopus 로고
    • American College of Chest Physicians. Prevention of VTE in orthopedic surgery patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines
    • Falck-Ytter Y, Francis CW, Johanson NA, etal. American College of Chest Physicians. Prevention of VTE in orthopedic surgery patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(Suppl 2):e278S-e325S.
    • (2012) Chest. , vol.141 , Issue.SUPPL. 2
    • Falck-Ytter, Y.1    Francis, C.W.2    Johanson, N.A.3
  • 9
    • 34547536841 scopus 로고    scopus 로고
    • 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
    • Warwick D, Friedman RJ, Agnelli G, etal. 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. J Bone Joint Surg Br. 2007;89(6):799-807.
    • (2007) J Bone Joint Surg Br. , vol.89 , Issue.6 , pp. 799-807
    • Warwick, D.1    Friedman, R.J.2    Agnelli, G.3
  • 10
    • 84856784474 scopus 로고    scopus 로고
    • American College of Chest Physicians. Oral anticoagulant therapy: Antithrombotic Therapy and Prevention of Thrombosis. 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines
    • Ageno W, Gallus AS, Wittkowsky A, Crowther M, Hylek EM, Palareti G. American College of Chest Physicians. Oral anticoagulant therapy: Antithrombotic Therapy and Prevention of Thrombosis. 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(Suppl 2):e44S-e88S.
    • (2012) Chest. , vol.141 , Issue.SUPPL. 2
    • Ageno, W.1    Gallus, A.S.2    Wittkowsky, A.3    Crowther, M.4    Hylek, E.M.5    Palareti, G.6
  • 11
    • 45949099359 scopus 로고    scopus 로고
    • Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty
    • RECORD1 Study Group
    • Eriksson BI, Borris LC, Friedman RJ, etal; RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008;358(26):2765-2775.
    • (2008) N Engl J Med. , vol.358 , Issue.26 , pp. 2765-2775
    • Eriksson, B.I.1    Borris, L.C.2    Friedman, R.J.3
  • 12
    • 46049106502 scopus 로고    scopus 로고
    • Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: A double-blind, randomised controlled trial
    • RECORD2 Investigators
    • Kakkar AK, Brenner B, Dahl OE, etal; 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):31-39.
    • (2008) Lancet. , vol.372 , Issue.9632 , pp. 31-39
    • Kakkar, A.K.1    Brenner, B.2    Dahl, O.E.3
  • 13
    • 45949103416 scopus 로고    scopus 로고
    • Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty
    • RECORD3 Investigators
    • Lassen MR, Ageno W, Borris LC, etal; RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008;358(26):2776-2786.
    • (2008) N Engl J Med. , vol.358 , Issue.26 , pp. 2776-2786
    • Lassen, M.R.1    Ageno, W.2    Borris, L.C.3
  • 14
    • 65549169515 scopus 로고    scopus 로고
    • Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): A randomised trial
    • RECORD4 Investigators
    • Turpie AGG, Lassen MR, Davidson BL, etal; RECORD4 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet. 2009;373(9676): 1673-1680.
    • (2009) Lancet. , vol.373 , Issue.9676 , pp. 1673-1680
    • Turpie, A.G.G.1    Lassen, M.R.2    Davidson, B.L.3
  • 15
    • 79952496003 scopus 로고    scopus 로고
    • Rivaroxaban for the prevention of venous thromboembolism after hip or knee arthroplasty. Pooled analysis of four studies
    • Turpie AGG, Lassen MR, Eriksson BI, etal. Rivaroxaban for the prevention of venous thromboembolism after hip or knee arthroplasty. Pooled analysis of four studies. Thromb Haemost. 2011;105(3):444-453.
    • (2011) Thromb Haemost. , vol.105 , Issue.3 , pp. 444-453
    • Turpie, A.G.G.1    Lassen, M.R.2    Eriksson, B.I.3
  • 16
    • 78951480208 scopus 로고    scopus 로고
    • Development of a framework for enhancing the transparency, reproducibility and communication of the benefit-risk balance of medicines
    • Coplan PM, Noel RA, Levitan BS, Ferguson J, Mussen F. Development of a framework for enhancing the transparency, reproducibility and communication of the benefit-risk balance of medicines. Clin Pharmacol Ther. 2011;89(2):312-315.
    • (2011) Clin Pharmacol Ther. , vol.89 , Issue.2 , pp. 312-315
    • Coplan, P.M.1    Noel, R.A.2    Levitan, B.S.3    Ferguson, J.4    Mussen, F.5
  • 17
    • 84897987032 scopus 로고    scopus 로고
    • London: European Medicines Agency; 2011, Available from, Accessed July 16
    • Benefit-risk methodology [webpage on the Internet]. London: European Medicines Agency; 2011. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000314.jsp&mid=WC0b01ac0580223ed6&murl=menus/special_topics/special_topics.jsp&jsenabled=true. Accessed July 16, 2013.
    • (2013) Benefit-risk methodology [webpage on the Internet]
  • 18
    • 78951477988 scopus 로고    scopus 로고
    • Application of the BRAT framework to case studies: Observations and insights
    • Levitan BS, Andrews EB, Gilsenan A, etal. Application of the BRAT framework to case studies: observations and insights. Clin Pharmacol Ther. 2011;89(2):217-224.
    • (2011) Clin Pharmacol Ther. , vol.89 , Issue.2 , pp. 217-224
    • Levitan, B.S.1    Andrews, E.B.2    Gilsenan, A.3
  • 19
    • 84884716641 scopus 로고    scopus 로고
    • US Food and Drug Administration; 2013, Available from, Accessed September 2
    • Structured Approach to Benefit-Risk Assessment in drug Regulatory Decision-Making. US Food and Drug Administration; 2013. Available from: http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM329758.pdf. Accessed September 2, 2013.
    • (2013) Structured Approach to Benefit-Risk Assessment in drug Regulatory Decision-Making
  • 20
    • 84897973118 scopus 로고    scopus 로고
    • Benefit-risk integration and representation [webpage on the Internet]
    • Available from, Accessed July 16
    • Benefit-risk integration and representation [webpage on the Internet]. PROTECT Investigators Innovative Medicines Initiative. Available from: http://www.imi-protect.eu/benefitPres.shtml. Accessed July 16, 2013.
    • (2013) PROTECT Investigators Innovative Medicines Initiative
  • 21
    • 78951480226 scopus 로고    scopus 로고
    • Refining the benefit-risk framework for the assessment of medicines: Valuing and weighting benefit and risk parameters
    • Walker S, Liberti L, McAuslane N, Levitan BS. Refining the benefit-risk framework for the assessment of medicines: valuing and weighting benefit and risk parameters. Clin Pharmacol Ther. 2011;89(2):179-182.
    • (2011) Clin Pharmacol Ther. , vol.89 , Issue.2 , pp. 179-182
    • Walker, S.1    Liberti, L.2    McAuslane, N.3    Levitan, B.S.4
  • 22
    • 79951985258 scopus 로고    scopus 로고
    • Effects of age, weight, gender and renal function in a pooled analysis of four rivaroxaban studies
    • PP-WE-421, RECORD 1-4 Investigators
    • Bauer KA, Turpie AGG, Lassen MR, Kakkar AK, Eriksson BI, Gent M; RECORD 1-4 Investigators. Effects of age, weight, gender and renal function in a pooled analysis of four rivaroxaban studies. J Thromb Haemost. 2009;7(S2):767:PP-WE-421.
    • (2009) J Thromb Haemost. , vol.7 , Issue.S2 , pp. 767
    • Bauer, K.A.1    Turpie, A.G.G.2    Lassen, M.R.3    Kakkar, A.K.4    Eriksson, B.I.5    Gent, M.6
  • 23
    • 65649094404 scopus 로고    scopus 로고
    • Oral rivaroxaban for the prevention of symptomatic venous thromboembolism after elective hip and knee replacement
    • Eriksson BI, Kakkar AK, Turpie AGG, etal. Oral rivaroxaban for the prevention of symptomatic venous thromboembolism after elective hip and knee replacement. J Bone Joint Surg Br. 2009;91(5):636-644.
    • (2009) J Bone Joint Surg Br. , vol.91 , Issue.5 , pp. 636-644
    • Eriksson, B.I.1    Kakkar, A.K.2    Turpie, A.G.G.3
  • 24
    • 79957715797 scopus 로고    scopus 로고
    • Anticoagulant options-why the FDA approved a higher but not a lower dose of dabigatran
    • Beasley BN, Unger EF, Temple R. Anticoagulant options-why the FDA approved a higher but not a lower dose of dabigatran. N Engl J Med. 2011;364(19):1788-1790.
    • (2011) N Engl J Med. , vol.364 , Issue.19 , pp. 1788-1790
    • Beasley, B.N.1    Unger, E.F.2    Temple, R.3
  • 25
    • 84897991546 scopus 로고    scopus 로고
    • A net clinical outcome analysis comparing fatal or irreversible ischemic and bleeding events in ATLAS ACS 2-TIMI 51
    • Gibson CM, Levitan B, Murphy SA, etal. A net clinical outcome analysis comparing fatal or irreversible ischemic and bleeding events in ATLAS ACS 2-TIMI 51. Circulation. 2012;126:A13152.
    • (2012) Circulation. , vol.126
    • Gibson, C.M.1    Levitan, B.2    Murphy, S.A.3
  • 26
    • 69749100371 scopus 로고    scopus 로고
    • State-of-the-art review: Assessing the safety profiles of new anticoagulants for major orthopedic surgery thromboprophylaxis
    • Hull RD, Yusen RD, Bergqvist D. State-of-the-art review: assessing the safety profiles of new anticoagulants for major orthopedic surgery thromboprophylaxis. Clin Appl Thromb Hemost. 2009;15(4):377-388.
    • (2009) Clin Appl Thromb Hemost. , vol.15 , Issue.4 , pp. 377-388
    • Hull, R.D.1    Yusen, R.D.2    Bergqvist, D.3
  • 27
    • 84897978383 scopus 로고    scopus 로고
    • Does rivaroxaban provide a clinically relevant favorable benefit-risk profile compared with enoxaparin after hip or knee arthroplasty?
    • A172
    • Kaul S, Diamond GA. Does rivaroxaban provide a clinically relevant favorable benefit-risk profile compared with enoxaparin after hip or knee arthroplasty? J Am Coll Cardiol. 2010;55(10):E1616-E1618: A172.
    • (2010) J Am Coll Cardiol. , vol.55 , Issue.10
    • Kaul, S.1    Diamond, G.A.2
  • 28
    • 78650511391 scopus 로고    scopus 로고
    • Quantitative benefit-risk assessment of rivaroxaban for the prevention of venous thromboembolism
    • Levitan B, Yuan Z, Turpie AGG, etal. Quantitative benefit-risk assessment of rivaroxaban for the prevention of venous thromboembolism. Blood (ASH Annual Meeting Abstracts). 2009;114(22):75-76:A169.
    • (2009) Blood (ASH Annual Meeting Abstracts). , vol.114 , Issue.22
    • Levitan, B.1    Yuan, Z.2    Turpie, A.G.G.3
  • 29
    • 69849100157 scopus 로고    scopus 로고
    • The net clinical benefit of warfarin anticoagulation in atrial fibrillation
    • Singer DE, Chang Y, Fang MC, etal. The net clinical benefit of warfarin anticoagulation in atrial fibrillation. Ann Intern Med. 2009;151(5): 297-305.
    • (2009) Ann Intern Med. , vol.151 , Issue.5 , pp. 297-305
    • Singer, D.E.1    Chang, Y.2    Fang, M.C.3
  • 30
    • 69949163560 scopus 로고    scopus 로고
    • Weighing benefits and risks-the FDA's review of prasugrel
    • Unger EF. Weighing benefits and risks-the FDA's review of prasugrel. N Engl J Med. 2009;361(10):942-945.
    • (2009) N Engl J Med. , vol.361 , Issue.10 , pp. 942-945
    • Unger, E.F.1
  • 31
    • 69749090257 scopus 로고    scopus 로고
    • Interpretation of benefit-risk of enoxaparin as comparator in the RECORD program: Rivaroxaban oral tablets (10 milligrams) for use in prophylaxis in deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery
    • Van Thiel D, Kalodiki E, Wahi R, Litinas E, Haque W, Rao G. Interpretation of benefit-risk of enoxaparin as comparator in the RECORD program: rivaroxaban oral tablets (10 milligrams) for use in prophylaxis in deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery. Clin Appl Thromb Hemost. 2009;15(4):389-394.
    • (2009) Clin Appl Thromb Hemost. , vol.15 , Issue.4 , pp. 389-394
    • Van Thiel, D.1    Kalodiki, E.2    Wahi, R.3    Litinas, E.4    Haque, W.5    Rao, G.6
  • 32
    • 84863224773 scopus 로고    scopus 로고
    • Dabigatran, rivaroxaban, or apixaban versus enoxaparin for thromboprophylaxis after total hip or knee replacement: Systematic review, meta-analysis, and indirect treatment comparisons
    • Gómez-Outes A, Terleira-Fernández AI, Suárez-Gea ML, Vargas-Castrillón E. Dabigatran, rivaroxaban, or apixaban versus enoxaparin for thromboprophylaxis after total hip or knee replacement: systematic review, meta-analysis, and indirect treatment comparisons. BMJ. 2012;344:e3675.
    • (2012) BMJ. , vol.344
    • Gómez-Outes, A.1    Terleira-Fernández, A.I.2    Suárez-Gea, M.L.3    Vargas-Castrillón, E.4
  • 33
    • 84898007953 scopus 로고    scopus 로고
    • Advisory Committee Briefing Book: Rivaroxaban for the Prophylaxis of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) in Patients Undergoing Hip or Knee Replacement Surgery
    • Available from, Accessed September 2
    • Advisory Committee Briefing Book: Rivaroxaban for the Prophylaxis of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) in Patients Undergoing Hip or Knee Replacement Surgery. Johnson & Johnson Pharmaceutical Research and Development, LLC; 2009. Available from: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/UCM138385.pdf. Accessed September 2, 2013.
    • (2013) Johnson & Johnson Pharmaceutical Research and Development, LLC; 2009
  • 34
    • 84870042793 scopus 로고    scopus 로고
    • The effects of rivaroxaban on the complications of surgery after total hip or knee replacement: Results from the RECORD programme
    • Lassen MR, Gent M, Kakkar AK, etal. The effects of rivaroxaban on the complications of surgery after total hip or knee replacement: results from the RECORD programme. J Bone Joint Surg Br. 2012;94(11): 1573-1578.
    • (2012) J Bone Joint Surg Br. , vol.94 , Issue.11 , pp. 1573-1578
    • Lassen, M.R.1    Gent, M.2    Kakkar, A.K.3
  • 35
    • 79955010436 scopus 로고    scopus 로고
    • Complications and functional outcomes after total hip arthroplasty and total knee arthroplasty: Results from the Global Orthopaedic Registry (GLORY)
    • Cushner F, Agnelli G, FitzGerald G, Warwick D. Complications and functional outcomes after total hip arthroplasty and total knee arthroplasty: results from the Global Orthopaedic Registry (GLORY). Am J Orthop (Belle Mead NJ). 2010;39(Suppl 9):22-28.
    • (2010) Am J Orthop (Belle Mead NJ). , vol.39 , Issue.SUPPL. 9 , pp. 22-28
    • Cushner, F.1    Agnelli, G.2    FitzGerald, G.3    Warwick, D.4
  • 36
    • 84866623327 scopus 로고    scopus 로고
    • Wound complications following rivaroxaban administration: A multicenter comparison with low-molecular-weight heparins for thromboprophylaxis in lower limb arthroplasty
    • Jameson SS, Rymaszewska M, James P, et al. 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.
    • (2012) J Bone Joint Surg Am. , vol.94 , Issue.17 , pp. 1554-1558
    • Jameson, S.S.1    Rymaszewska, M.2    James, P.3
  • 37
    • 78651252397 scopus 로고    scopus 로고
    • Return to theatre following total hip and knee replacement, before and after the introduction of rivaroxaban: A retrospective cohort study
    • Jensen CD, Steval A, Partington PF, Reed MR, Muller SD. Return to theatre following total hip and knee replacement, before and after the introduction of rivaroxaban: a retrospective cohort study. J Bone Joint Surg Br. 2011;93(1):91-95.
    • (2011) J Bone Joint Surg Br. , vol.93 , Issue.1 , pp. 91-95
    • Jensen, C.D.1    Steval, A.2    Partington, P.F.3    Reed, M.R.4    Muller, S.D.5
  • 38
    • 79952114761 scopus 로고    scopus 로고
    • Preferences in traumatic intracranial hemorrhage: Bleeding vs. clotting
    • Chan CM, Zilberberg MD. Preferences in traumatic intracranial hemorrhage: bleeding vs. clotting. Crit Care. 2010;14(3):153.
    • (2010) Crit Care. , vol.14 , Issue.3 , pp. 153
    • Chan, C.M.1    Zilberberg, M.D.2
  • 39
    • 84870937675 scopus 로고    scopus 로고
    • Thromboembolism and antithrombotic therapy for heart failure in sinus rhythm. An Executive Summary of a joint Consensus Document from the ESC Heart Failure Association and the ESC Working Group on Thrombosis
    • Lip GYH, Piotrponikowski P, Andreotti F, etal. Thromboembolism and antithrombotic therapy for heart failure in sinus rhythm. An Executive Summary of a joint Consensus Document from the ESC Heart Failure Association and the ESC Working Group on Thrombosis. Thromb Haemost. 2012;108(6): 1009-1022.
    • (2012) Thromb Haemost. , vol.108 , Issue.6 , pp. 1009-1022
    • Lip, G.Y.H.1    Piotrponikowski, P.2    Andreotti, F.3


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