State-of-the-art review: Assessing the safety profiles of new anticoagulants for major orthopedic surgery thromboprophylaxis

Clinical and Applied Thrombosis/Hemostasis

Volumn 15, Issue 4, 2009, Pages 377-388

  Hull, Russell D ^a   Yusen, Roger D ^b   Bergqvist, David ^c  

^a UNIVERSITY OF CALGARY   (Canada)

^b WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c UPPSALA UNIVERSITY HOSPITAL   (Sweden)

Author keywords

Anticoagulants; Bleeding; Major orthopedic surgery; Thromboprophylaxis

Indexed keywords

DABIGATRAN; ENOXAPARIN; FONDAPARINUX; MELAGATRAN; RIVAROXABAN; XIMELAGATRAN;

ANTICOAGULANT THERAPY; BRAIN HEMORRHAGE; CLINICAL TRIAL; DRUG EFFICACY; DRUG SAFETY; HEMOPERICARDIUM; HIP ARTHROPLASTY; HUMAN; PRIORITY JOURNAL; RETROPERITONEAL HEMORRHAGE; REVIEW; SPINAL HEMATOMA; THROMBOSIS PREVENTION; VENOUS THROMBOEMBOLISM; WOUND COMPLICATION;

ANTICOAGULANTS; HUMANS; ORTHOPEDIC PROCEDURES; POSTOPERATIVE HEMORRHAGE; RISK FACTORS; THROMBOSIS;

EID: 69749100371     PISSN: 10760296     EISSN: None     Source Type: Journal    
DOI: 10.1177/1076029609338712     Document Type: Review

References (41)

1. Geerts WH, Bergqvist D., Pineo GF, et al. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8 th Edition). Chest. 2008 ; 133 (6 suppl). 381S - 453S.
2. Nurmohamed MT, Rosendaal FR, Büller HR, et al. Low-molecular-weight heparin versus standard heparin in general and orthopaedic surgery: a meta-analysis. Lancet. 1992 ; 340 (8812). 152-156.
3. Leizorovicz A., Haugh MC, Chapuis FR, Samama MM, Boissel JP Low molecular weight heparin in prevention of perioperative thrombosis. BMJ. 1992 ; 305 (6859). 913-920.
4. Paiement GD, Wessinger SJ, Hughes R., Harris WH Routine use of adjusted low-dose warfarin to prevent venous thromboembolism after total hip replacement. J Bone Joint Surg Am. 1993 ; 75 (6). 893-898.
5. Turpie AG, Bauer KA, Eriksson BI, Lassen MR Fondaparinux vs enoxaparin for the prevention of venous thromboembolism in major orthopedic surgery: a meta-analysis of 4 randomized double-blind studies. Arch Intern Med. 2002 ; 162 (16). 1833-1840.
6. Deitelzweig SB, McKean SC, Amin AN, Brotman DJ, Jaffer AK, Spyropoulos AC Prevention of venous thromboembolism in the orthopedic surgery patient. Cleve Clin J Med. 2008 ; 75 (suppl 3). S27 - S36.
7. Haas S. Deep vein thrombosis: beyond the operating table. Orthopedics. 2000 ;23(6 suppl): S629 - S632.
8. Cohen AT, Agnelli G., Anderson FA, et al. Venous thromboembolism (VTE) in Europe. The number of VTE events and associated morbidity and mortality. Thromb Haemost. 2007 ; 98 (4). 756-764.
9. Cohen AT, Tapson VF, Bergman JF, et al. Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study): a multinational cross-sectional study. Lancet. 2008 ; 371 (9610). 387-394.
10. Harneberg J., Wehling M. Current and future prospects for anticoagulant therapy: inhibitors of factor Xa and factor IIa. Semin Thromb Hemost. 2008 ; 34 (1). 39-57.
11. Committee for Medicinal Products for Human Use (CHMP). Guideline on clinical investigation of medicinal products for prophylaxis of high intra- and postoperative venous thromboembolic risk, 15 November 2007. http://www.emea. europa.eu/pdfs/human/ewp/70798en-fin.pdf. Accessed February 23, 2009.
12. Dahl OE, Borris LC, Bergqvist D., et al. Major joint replacement. A model for antithrombotic drug development: from proof-of-concept to clinical use. Int Angiol. 2008 ; 27 (1). 60-67.
13. Schulman S., Beyth RJ, Kearon C., Levine MN, and the American College of Chest Physicians. Hemorrhagic complications of anticoagulant and thrombolytic treatment. American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 ; 133 (6 suppl). 257S - 298S. (Pubitemid 351892969)
14. Turpie AG, Bauer KA, Eriksson BI, Lassen MR, for the PENTATHALON 2000 Study Steering Committee. Postoperative fondaparinux versus postoperative enoxaparin for prevention of venous thromboembolism after elective hip-replacement surgery: a randomised double-blind trial. Lancet. 2002 ; 359 (9319). 1721-1726.
15. Colwell CW Jr, Berkowitz SD, Davidson BL, et al. Comparison of ximelagatran, an oral direct thrombin inhibitor, with enoxaparin for the prevention of venous thromboembolism following total hip replacement. A randomized, double-blind study. J Thromb Haemost. 2003 ; 1 (10). 2119-2130.
16. Eriksson BI, Agnelli G., Cohen AT, et al. The direct thrombin inhibitor melagatran followed by oral ximelagatran compared with enoxaparin for the prevention of venous thromboembolism after total hip or knee replacement: the EXPRESS study. J Thromb Haemost. 2003 ; 1 (12). 2490-2496.
17. Eriksson BI, Borris LC, Dahl OE, et al. A once-daily, oral, direct Factor Xa inhibitor, rivaroxaban (BAY 59-7939), for thromboprophylaxis after total hip replacement. Circulation. 2006 ; 114 (22). 2374-2381.
18. Erikkson BI, Dahl OE, Rosencher N., 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.
19. Lassen MR, Ageno W., Borris LC, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008 ; 358 (26). 2776-2786.
20. Lassen MR, Bauer KA, Eriksson BI, Turpie AG, for the European Pentasaccharide Elective Surgery Study (EPHESUS) Steering Committee. Postoperative fondaparinux versus preoperative enoxaparin for prevention of venous thromboembolism in elective hip-replacement surgery: a randomised double-blind comparison. Lancet. 2002 ; 359 (9319). 1715-1720.
21. Eriksson BI, Bauer KA, Lassen MR, Turpie AG, for the Steering Committee of the Pentasaccharide Hip-Fracture Surgery Study. Fondaparinux compared with enoxaparin for the prevention of venous thromboembolism after hip-fracture surgery. N Engl J Med. 2001 ; 345 (18). 1298-1304.
22. Bauer KA, Eriksson BI, Lassen MR, Turpie AG, for the Steering Committee of the Pentasaccharide in Major Knee Surgery Study. Fondaparinux compared with enoxaparin for the prevention of venous thromboembolism after elective major knee surgery. N Engl J Med. 2001 ; 345 (18). 1305-1310.
23. Eriksson BI, Agnelli G., Cohen AT, et al. Direct thrombin inhibitor melagatran followed by oral ximelagatran in comparison with enoxaparin for prevention of venous thromboembolism after total hip or knee replacement. Thromb Haemost. 2003 ; 89 (2). 288-296.
24. Erikkson BI, Dahl OE, Büller HR, et al. A new oral direct thrombin inhibitor, dabigatran etexilate, compared with enoxaparin for prevention of thromboembolic events following total hip or knee replacement: the BISTRO II randomized trial. J Thromb Haemost. 2005 ; 3 (1). 103-111.
25. Eriksson BI, Dahl OE, Rosencher N., et al. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet. 2007 ; 370 (9591). 949-956. (Pubitemid 47393577)
26. RE-MOBILIZE Writing Committee. Ginsberg JS, Davidson BL, et al. The oral thrombin inhibitor dabigatran etexilate vs the North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery. J Arthroplasty. 2009 ; 24 (1). 1-9.
27. Eriksson BI, Borris LC, Friedman RJ, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008 ; 358 (26). 2765-2775.
28. Kakkar AK, Brenner B., Dahl OE, et al. 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.
29. Levine MN, Hirsh J., Gent M., et al. Prevention of deep vein thrombosis after elective hip surgery. A randomized trial comparing low molecular weight heparin with standard unfractionated heparin. Ann Intern Med. 1991 ; 114 (7). 545-551.
30. Planes A., Vochelle N., Mazas F., et al. Prevention of postoperative venous thrombosis: a randomized trial comparing unfractionated heparin with low molecular weight heparin in patients undergoing total hip replacement. Thromb Haemost. 1988 ; 60 (3). 407-410.
31. Colwell CW Jr, Spiro TE, Trowbridge AA, et al. Use of enoxaparin, a low-molecular-weight heparin, and unfractionated heparin for the prevention of deep venous thrombosis after elective hip replacement. A clinical trial comparing efficacy and safety. Enoxaparin Clinical Trial Group. J Bone Joint Surg Am. 1994 ; 76 (1). 3-14.
32. Faunø P., Suomalainen O., Rehnberg V., et al. Prophylaxis for the prevention of venous thromboembolism after total knee arthroplasty. A comparison between unfractionated and low-molecular-weight heparin. J Bone Joint Surg Am. 1994 ; 76 (12). 1814-1818.
33. Colwell CW Jr, Spiro TE, Trowbridge AA, Stephens JW, Gardiner GA Jr, Ritter MA Efficacy and safety of enoxaparin versus unfractionated heparin for prevention of deep venous thrombosis after elective knee arthroplasty. Enoxaparin Clinical Trial Group. Clin Orthop Relat Res. 1995 ; 321: 19-27.
34. Agnelli G., Eriksson BI, Cohen AT, et al. Safety assessment of new antithrombotic agents: Lessons from the EXTEND study on ximelagatran. Thromb Res. 2009; 123 (3). 488-497.
35. Eriksson BI, Borris L., Dahl OE, et al. Oral, direct Factor Xa inhibition with BAY 59-7939 for the prevention of venous thromboembolism after total hip replacement. J Thromb Haemost. 2006 ; 4 (1). 121-128.
36. Turpie AG, Fisher WD, Bauer KA, et al. BAY 59-7939: an oral, direct Factor Xa inhibitor for the prevention of venous thromboembolism in patients after total knee replacement surgery. A phase II dose-ranging study. J Thromb Haemost. 2005 ; 3 (11). 2479-2486.
37. Cohen AT, Hirst C., Sherril B., Holmes P., Fidan D. Meta-analysis of trials comparing ximelagatran with low molecular weight heparin for prevention of venous thromboembolism after major orthopaedic surgery. Br J Surg. 2005 ; 92 (11). 1335-1344.
38. Raskob GE, Hirsh J. Controversies in timing of the first dose of anticoagulant prophylaxis against venous thromboembolism after major orthopedic surgery. Chest. 2003 ; 124 (6 suppl). 379S - 385S.
39. Hull RD, Pineo GF, Francis C., et al. Low-molecular-weight heparin prophylaxis using dalteparin in close proximity to surgery vs warfarin in hip arthroplasty patients: a double-blind, randomized comparison. The North American Fragmin Trial Investigators. Arch Intern Med. 2000 ; 160 (14). 2199-2207. (Pubitemid 30482728)
40. Lillo-Le Louet A., Smadja D., Le Beller C. National pharmacovigilance enquiry about Arixtra® (fondaparinux) [abstract]. Drug Safety. 2007 ; 30 (10). 919-990.
41. Hull RD, Mah AF Reporting the NAFT major bleeding rates in context: reviewers should include site investigator-classified rates. Arch Intern Med. 2003 ; 163 (3). 369.