Ximelagatran versus warfarin for the prevention of venous thromboembolism after total knee arthroplasty: A randomized, double-blind trial

Annals of Internal Medicine

Volumn 137, Issue 8, 2002, Pages 648-655

  Francis, Charles W ^a   Davidson, Bruce L ^a   Berkowitz, Scott D ^a   Lotke, Paul A ^a   Ginsberg, Jeffrey S ^a   Lieberman, Jay R ^a   Webster, Anne K ^a   Whipple, James P ^a   Peters, Gary R ^a   Colwell Jr , Clifford W ^a  

^a UNIVERSITY OF ROCHESTER MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

THROMBIN INHIBITOR; WARFARIN; XIMELAGATRAN;

ADULT; AGED; ARTICLE; BLOOD CLOTTING; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEEP VEIN THROMBOSIS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG MONITORING; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GASTROINTESTINAL HEMORRHAGE; HEMATOMA; HUMAN; INCIDENCE; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; PHASE 3 CLINICAL TRIAL; PHLEBOGRAPHY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; THROMBOEMBOLISM; TOTAL HIP PROSTHESIS; TOTAL KNEE REPLACEMENT; TREATMENT OUTCOME; VEIN THROMBOSIS;

EID: 0037108825     PISSN: 00034819     EISSN: None     Source Type: Journal    
DOI: 10.7326/0003-4819-137-8-200210150-00008     Document Type: Article

References (44)

1. Clagett GP, Anderson FA Jr, Geerts W, Heit JA, Knudson M, Lieberman JR, et al. Prevention of venous thromboembolism. Chest. 1998;114:531S-560S. [PMID: 9822062]
2. Gross M, Anderson DR, Nagpal S, O'Brien B. Venous thromboembolism prophylaxis after total hip or knee arthroplasty: a survey of Canadian orthopedic surgeons. Can J Surg. 1999;42:457-61. [PMID: 10593248]
3. Iobst CA, Friedman RJ. The role of low molecular weight heparin in total knee arthroplasty. Am J Knee Surg. 1999;12:55-60. [PMID: 10050695]
4. Hirsh J, Dalen JE, Anderson DR, Poller L, Bussey H, Ansell J, et al. Oral anticoagulants: mechanism of action, clinical effectiveness, and optimal therapeutic range. Chest. 1998;114:445S-469S. [PMID: 9822057]
5. Eriksson UG, Johansson L, Frison L, Bredberg U, Gustafsson D. Single and repeated oral dosing of H 376/95, a prodrug of the direct thrombin inhibitor melagatran, to young healthy male subjects [Abstract]. Blood. 1999;94(Suppl 1):26a.
6. Eriksson UG, Frison L, Gustafsson D, Mandema J, Karlsson MO, Eriksson BI. The pharmacokinetics of melagatran, the active form of the oral direct thrombin inhibitor, ximelagatran (pINN, formerly H 376/95), in orthopaedic surgery patients treated to prevent DVT and pulmonary embolism [Abstract]. XVIII Congress of the International Society on Thrombosis and Haemostasis, 6-12 July 2001, Paris, France. Abstract no. P3092.
7. Peters G, Whipple J, Eriksson UG. Pharmacokinetics of H 376/95, a novel oral direct thrombin inhibitor, in patients undergoing total knee arthroplasty [Abstract]. Clin Pharmacol Ther 2001;69:35.
8. Eriksson BI, Lindbratt S, Kälebo P, Bylock A, Frison L, Welin L, et al. METHRO II: dose-response study of the novel oral direct thrombin inhibitor, H 376/95, and its subcutaneous formulation, melagatran, compared with dalteparin as thromboembolic prophylaxis after total hip or total knee replacement. Lancet [In press].
9. Heit JA, Colwell CW, Francis CW, Ginsberg JS, Berkowitz SD, Whipple J, et al. Comparison of the oral direct thrombin inhibitor ximelagatran with enoxaparin as prophylaxis against venous thromboembolism after total knee replacement: a phase 2 dose-finding study. Arch Intern Med. 2001;161:2215-21. [PMID: 11575978]
10. Rabinov K, Paulin S. Roentgen diagnosis of venous thrombosis in the leg. Arch Surg. 1972;104:134-44. [PMID: 5008903]
11. Kälebo P, Ekman S, Lindbratt S, Eriksson BI, Pauli U, Zachrisson BE, et al. Percentage of inadequate phlebograms and observer agreement in thromboprophylactic multicenter trials using standardized methodology and central assessment. Thromb Haemost. 1996;76:893-6. [PMID: 8972007]
12. Eriksson BI, Bauer KA, Lassen MR, Turpie AG. Fondaparinux compared with enoxaparin for the prevention of venous thromboembolism after hip-fracture surgery. N Engl J Med. 2001;345:1298-304. [PMID: 11794148]
13. Bauer KA, Eriksson BI, Lassen MR, Turpie AG. Fondaparinux compared with enoxaparin for the prevention of venous thromboembolism after elective major knee surgery. N Engl J Med. 2001;345:1305-10. [PMID: 11794149]
14. Leclerc JR, Geerts WH, Desjardins L, Laflamme GH, L'Espérance B, Demers C, et al. Prevention of venous thromboembolism after knee arthroplasty. A randomized, double-blind trial comparing enoxaparin with warfarin. Ann Intern Med. 1996;124:619-26. [PMID: 8607589]
15. Francis CW, Pellegrini VD Jr, Leibert KM, Totterman S, Azodo MV, Harris CM, et al. Comparison of two warfarin regimens in the prevention of venous thrombosis following total knee replacement. Thromb Haemost. 1996;75:706-11. [PMID: 8725709]
16. Heit JA, Berkowitz SD, Bona R, Cabanas V, Corson JD, Elliott CG, et al. Efficacy and safety of low molecular weight heparin (ardeparin sodium) compared to warfarin for the prevention of venous thromboembolism after total knee replacement surgery: a double-blind, dose-ranging study. Ardeparin Arthroplasty Study Group. Thromb Haemost. 1997;77:32-8. [PMID: 9031445]
17. 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;329:1370-6. [PMID: 8413432]
18. RD heparin compared with warfarin for prevention of venous thromboembolic disease following total hip or knee arthroplasty. RD Heparin Arthroplasty Group. J Bone Joint Surg Am. 1994;76:1174-85. [PMID: 8056798]
19. Hamulyák K, Lensing AW, van der Meer J, Smid WM, van Ooy A, Hoek JA. Subcutaneous low-molecular weight heparin or oral anticoagulants for the prevention of deep-vein thrombosis in elective hip and knee replacement? Fraxiparine Oral Anticoagulant Study Group. Thromb Haemost. 1995;74:1428-31. [PMID: 8772214]
20. Fitzgerald RH Jr, Spiro TE, Trowbridge AA, Gardiner GA Jr, Whitsett TL, O'Connell MB, et al. Prevention of venous thromboembolic disease following primary total knee arthroplasty. A randomized, multicenter, open-label, parallel-group comparison of enoxaparin and warfarin. J Bone Joint Surg Am. 2001;83-A:900-6. [PMID: 11407799]
21. Geerts WH, Heit JA, Clagett GP, Pineo GF, Colwell CW, Anderson FA Jr, et al. Prevention of venous thromboembolism. Chest. 2001;119:132S-175S. [PMID: 11157647]
22. Howard AW, Aaron SD. Low molecular weight heparin decreases proximal and distal deep venous thrombosis following total knee arthroplasty. A meta-analysis of randomized trials. Thromb Haemost. 1998;79:902-6. [PMID: 9609217]
23. Collins R, Scrimgeour A, Yusuf S, Peto R. Reduction in fatal pulmonary embolism and venous thrombosis by perioperative administration of subcutaneous heparin. Overview of results of randomized trials in general, orthopedic, and urologic surgery. N Engl J Med. 1988;318:1162-73. [PMID: 3283548]
24. Havig O. Deep vein thrombosis and pulmonary embolism. An autopsy study with multiple regression analysis of possible risk factors. Acta Chir Scand Suppl. 1977;478:1-120. [PMID: 146995]
25. Moser KM, LeMoine JR. Is embolic risk conditioned by location of deep venous thrombosis? Ann Intern Med. 1981;94:439-44. [PMID: 7212500]
26. Eriksson BI, Kälebo P, Anthymyr BA, Wadenvik H, Tengborn L, Risberg B. Prevention of deep-vein thrombosis and pulmonary embolism after total hip replacement. Comparison of low-molecular-weight heparin and unfractionated heparin. J Bone Joint Surg Am. 1991;73:484-93. [PMID: 2013587]
27. Francis CW, Pellegrini VD Jr, Totterman S, Boyd AD Jr, Marder VJ, Liebert KM, et al. Prevention of deep-vein thrombosis after total hip arthroplasty. Comparison of warfarin and dalteparin. J Bone Joint Surg Am. 1997;79:1365-72. [PMID: 9314399]
28. Eriksson BI, Ekman S, Kalebo P, Zachrisson B, Bach D, Close P. Prevention of deep-vein thrombosis after total hip replacement: direct thrombin inhibition with recombinant hirudin, CGP 39393. Lancet. 1996;347:635-9. [PMID: 8596376]
29. Eriksson BI, Wille-Jørgensen P, Kälebo P, Mouret P, Rosencher N, Bösch P, et al. A comparison of recombinant hirudin with a low-molecular-weight heparin to prevent thromboembolic complications after total hip replacement. N Engl J Med. 1997;337:1329-35. [PMID: 9358126]
30. Eriksson BI, Ekman S, Lindbratt S, Baur M, Bach D, Torholm C, et al. Prevention of thromboembolism with use of recombinant hirudin. Results of a double-blind, multicenter trial comparing the efficacy of desirudin (Revasc) with that of unfractionated heparin in patients having a total hip replacement. J Bone Joint Surg Am. 1997;79:326-33. [PMID: 9070519]
31. Ginsberg JS, Nurmohamed MT, Gent M, MacKinnon B, Sicurella J, Brill-Edwards P, et al. Use of Hirulog in the prevention of venous thrombosis after major hip or knee surgery. Circulation. 1994;90:2385-9. [PMID: 7955198]
32. Maynard MJ, Sculco TP, Ghelman B. Progression and regression of deep vein thrombosis after total knee arthroplasty. Clin Orthop. 1991;273:125-30. [PMID: 1959259]
33. Bredberg U, Eriksson UG, Taure K, Johansson L, Frison L, Gustafsson D. Effects of melagatran, a novel direct thrombin inhibitor, in healthy volunteers following intravenous, subcutaneous and oral administration [Abstract]. Blood 1999;94(Suppl 1):28a.
34. Johansson L, Eriksson UG, Frison L, Fager G. Pharmacokinetics of H 376/95 in young and elderly healthy patients [Abstract]. Blood. 2000;96:57a.
35. Eriksson UG, Johansson L, Frison L, Mandema J, Karlsson MO, Eriksson B, et al. Pharmacokinetics of melagatran in young and elderly healthy subjects and orthopaedic surgery patients [Abstract]. Clin Pharmacol Ther. 2001;69:24.
36. Eriksson UG, Fager G, Eriksson-Lipkowska M, Cullberg M, Frison L, Bylock A, et al. Effect of acetyl salicyllic acid (ASA) on the pharmacodynamics and pharmacokinetics of melagatran, active form of the oral direct thrombin inhibitor, H 376/95 [Abstract]. Clin Pharmacol Ther. 2001;69:24.
37. Eriksson-Lipkowska M, Thuresson A, Bylock A, Frison L, Eriksson UG. The effect of the oral direct thrombin inhibitor, ximelagatran (pINN, formerly H 376/95), on the pharmacokinetics of diazepam in healthy male volunteers [Abstract]. XVIII Congress of the International Society on Thrombosis and Haemostasis, 6-12 July 2001, Paris, France. Abstract no. P785.
38. Eriksson-Lipkowska M, Thuresson A, Bylock A, Frison L, Eriksson UG. The effect of the oral direct thrombin inhibitor, ximelagatran (pINN, formerly H 376/95), on the pharmacokinetics and pharmacodynamics of diclofenac in healthy male volunteers [Abstract]. XVIII Congress of the International Society on Thrombosis and Haemostasis, 6-12 July 2001, Paris, France. Abstract no. P786.
39. Johansson S, Bylock A, Eriksson-Lepkowska M, Thuresson A, Frison L, Eriksson UG. The effect of the oral direct thrombin inhibitor, ximelagatran (pINN, formerly H 376/95), on the pharmacokinetics of nifedipine, in healthy male volunteers [Abstract]. XVIII Congress of the International Society on Thrombosis and Haemostasis, 6-12 July 2001, Paris, France. Abstract no. P784.
40. Elg M, Gustafsson D, Carlsson S. Antithrombotic effects and bleeding time of thrombin inhibitors and warfarin in the rat. Thromb Res. 1999;94:187-97. [PMID: 10326765]
41. Elg M, Gustafsson D, Deinum J. The importance of enzyme inhibition kinetics for the effect of thrombin inhibitors in a rat model of arterial thrombosis. Thromb Haemost. 1997;78:1286-92. [PMID: 9364999]
42. Eriksson BI, Carlsson S, Halvarsson M, Risberg B, Mattsson C. Antithrombotic effect of two low molecular weight thrombin inhibitors and a low-molecular weight heparin in a caval vein thrombosis model in the rat. Thromb Haemost. 1997;78:1404-7. [PMID: 9408027]
43. Eriksson UG, Frison L, Gustafsson D, Mandema J, Karlsson MO, Wahlby U, et al. Effect of metagatran, the active form of the oral direct thrombin inhibitor, H 376/95, on activated partial thromboplasdin time (APTT) in orthopaedic surgery patients treated to prevent DVT and pulmonary embolism [Abstract]. Blood. 2000;96:93b.
44. Eriksson UG, Frison L, Gustafsson D, Mandema J, Karlsson MO, Eriksson B. Pharmacokinetics of melagatran, the active form of the oral direct thrombin inhibitor, H 376/95, in orthopaedic surgery patients treated to prevent DVT and pulmonary embolism [Abstract]. Blood. 2000;96:93b.