Risk of recurrent venous thromboembolism or bleeding in relation to thrombophilic risk factors in patients receiving ximelagatran or placebo for long-term secondary prevention of venous thromboembolism

British Journal of Haematology

Volumn 133, Issue 1, 2006, Pages 68-77

  Wåhlander, Karin ^a   Eriksson, Henry ^b   Lundström, Torbjörn ^a   Clason, Solveig Billing ^a   Wall, Ulrika ^a   Nyström, Per ^a   Wessman, Peter ^a   Schulman, Sam ^c,d  

^a ASTRAZENECA R AND D   (Sweden)

^b SAHLGRENSKA UNIVERSITY HOSPITAL   (Sweden)

^c HAMILTON HEALTH SCIENCES   (Canada)

^d KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

Author keywords

Oral direct thrombin inhibitor; THRombin Inhibitor in Venous thrombo Embolism III; Thrombophilic defects; Venous thromboembolism; Ximelagatran

Indexed keywords

ANTITHROMBIN; BLOOD CLOTTING FACTOR 5 LEIDEN; CARDIOLIPIN ANTIBODY; PLACEBO; PROTEIN C; PROTEIN S; XIMELAGATRAN;

ADULT; ARTICLE; BLEEDING; BRAIN HEMORRHAGE; CONTROLLED STUDY; FEMALE; GENE MUTATION; HUMAN; MAJOR CLINICAL STUDY; MALE; PATIENT SELECTION; PRIORITY JOURNAL; PROPORTIONAL HAZARDS MODEL; RECURRENT DISEASE; RETROPERITONEAL HEMORRHAGE; RISK FACTOR; SECONDARY PREVENTION; THROMBOPHILIA; TREATMENT OUTCOME; VENOUS THROMBOEMBOLISM;

ANTIBODIES, ANTICARDIOLIPIN; ANTICOAGULANTS; ANTITHROMBINS; AZETIDINES; BENZYLAMINES; BIOLOGICAL MARKERS; BLOOD COAGULATION TESTS; ETHNIC GROUPS; EUROPE; FACTOR V; HEMORRHAGE; HUMANS; PROPORTIONAL HAZARDS MODELS; PROTEIN S; RECURRENCE; RISK; THROMBOEMBOLISM; THROMBOPHILIA; TREATMENT OUTCOME;

EID: 33644656476     PISSN: 00071048     EISSN: 13652141     Source Type: Journal    
DOI: 10.1111/j.1365-2141.2006.05960.x     Document Type: Article

References (28)

1. Anderson F.A. Jr. Spencer F.A. 2003 Risk factors for venous thromboembolism Circulation 107 Suppl. 1 I9 I16
2. Ansell J. Hirsh J. Poller L. Bussey H. Jacobson A. Hylek E. 2004 The pharmacology and management of the vitamin K antagonists Chest 126 Suppl. 3 204S 233S
3. Baglin T. Luddington R. Brown K. Baglin C. 2003 Incidence of recurrent venous thromboembolism in relation to clinical and thrombophilic risk factors: prospective cohort study Lancet 362 523 526
4. Bates S.M. Ginsberg J.S. 2004 Clinical practice. Treatment of deep-vein thrombosis New England Journal of Medicine 351 268 277
5. Bauer K.A. 2004 Role of thrombophilia in deciding duration of anticoagulation Seminars in Thrombosis and Hemostasis 30 633 637
6. Büller H.R. Agnelli G. Hull R.D. Hyers T.M. Prins M.H. Raskob G.E. 2004 Antithrombotic therapy for venous thromboembolic disease Chest 126 Suppl. 3 401S 428S
7. Dahl O.E. Eriksson B.I. Agnelli G. Cohen A.T. Mouret P. Rosencher N. Panfilov S. Bylock A. Andersson M. 2005 Postoperative melagatran/ximelagatran for the prevention of venous thromboembolism following major elective orthopaedic surgery. Effects of timing of first dose and risk factors for thromboembolism and bleeding complications on efficacy and safety Clinical Drug Investigation 25 65 77
8. Dahlback B. 2000 Blood coagulation Lancet 355 1627 1632
9. Eriksson B.I. Agnelli G. Cohen A.T. Dahl O.E. Mouret P. Rosencher N. Eskilson C. Nylander I. Frison L. Ögren M. on behalf of the METHRO III Study Group 2003 Direct thrombin inhibitor melagatran followed by oral ximelagatran in comparison with enoxaparin for prevention of venous thromboembolism after total hip or knee replacement. The METHRO III study Thrombosis and Haemostasis 89 288 296
10. Eriksson H. Lundström T. Wåhlander K. Billing Clason S. Schulman S. for the THRIVE III Investigators 2005 Prognostic factors for recurrence of venous thromboembolism (VTE) or bleeding during long-term secondary prevention of VTE with ximelagatran Thrombosis and Haemostasis 94 522 527
11. Ersdal E. Schützer K.-M. Lönnerstedt C. Ohlsson L. Wall U. Eriksson U.G. 2005 No influence of food on the pharmacokinetics, pharmacodynamics or tolerability of the 24 mg and 36 mg oral tablet formulations of ximelagatran Clinical Drug Investigation 25 425 433
12. Executive Steering Committee on behalf of the SPORTIF III Investigators 2003 Stroke prevention with the oral direct thrombin inhibitor ximelagatran compared with warfarin in patients with non-valvular atrial fibrillation (SPORTIF III): randomised controlled trial Lancet 362 1691 1698
13. Fiessinger J.-N. Huisman M.V. Davidson B.L. Bounameaux H. Francis C.W. Eriksson H. Lundström T. Berkowitz S.D. Nyström P. Thorsén M. Ginsberg J.S. for the THRIVE Treatment Study Investigators 2005 Ximelagatran vs low-molecular-weight heparin and warfarin for the treatment of deep vein thrombosis: a randomized controlled trial JAMA 293 681 689
14. Gallus A.S. 2005 Management options for thrombophilias Seminars in Thrombosis and Hemostasis 31 118 126
15. Gustafsson D. Elg M. 2003 The pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor ximelagatran and its active metabolite melagatran: a mini-review Thrombosis Research 109 S9 S15
16. Kearon C. Gent M. Hirsh J. Weitz J. Kovacs M.J. Anderson D.R. Turpie A.G. Green D. Ginsberg J.S. Wells P. MacKinnon B. Julian J.A. Johnston M. Douketis J. Roberts R. van Nguyen P. Kassis J. Dolan S. Demers C. Desjardins L. Solymoss S. Trowbridge A. 1999 A comparison of three months of anticoagulation with extended anticoagulation for a first episode of idiopathic venous thromboembolism New England Journal of Medicine 340 901 907
17. Kearon C. Ginsberg J.S. Kovacs M.J. Anderson D.R. Wells P. Julian J.A. MacKinnon B. Weitz J.I. Crowther M.A. Dolan S. Turpie A.G. Geerts W. Solymoss S. van Nguyen P. Demers C. Kahn S.R. Kassis J. Rodger M. Hambleton J. Gent M. for the Extended Low-Intensity Anticoagulation for Thrombo-Embolism Investigators 2003 Comparison of low-intensity warfarin therapy with conventional-intensity warfarin therapy for long-term prevention of recurrent venous thromboembolism New England Journal of Medicine 349 631 639
18. Lee W.M. Larrey D. Olsson R. Lewis J.H. Keisu M. Auclert L. Sheth S. 2005 Hepatic findings in long-term clinical trials of ximelagatran Drug Safety 28 351 370
19. Lindmarker P. Schulman S. Sten-Linder M. Wiman B. Egberg N. Johnsson H. 1999 The risk of recurrent venous thromboembolism in carriers and non-carriers of the G1691A allele in the coagulation factor V gene and the G20210A allele in the prothrombin gene. DURAC Trial Study Group. Duration of anticoagulation Thrombosis and Haemostasis 81 684 689
20. Ridker P.M. Goldhaber S.Z. Danielson E. Rosenberg Y. Eby C. S. Deitcher S.R. Cushman M. Moll S. Kessler C.M. Elliott C.G. Paulson R. Wong T. Bauer K.A. Schwartz B.A. Miletich J.P. Bounameaux H. Glynn R.J. for the PREVENT Investigators 2003 Long-term, low-intensity warfarin therapy for the prevention of recurrent venous thromboembolism New England Journal of Medicine 348 1425 1434
21. Rosendaal F.R. 1999 Venous thrombosis: a multicausal disease Lancet 353 1167 1173
22. Rosendaal F.R. Doggen C.J. Zivelin A. Arruda V.R. Aiach M. Siscovick D.S. Hillarp A. Watzke H.H. Bernardi F. Cumming A.M. Preston F.E. Reitsma P.H. 1998 Geographic distribution of the 20210 G to A prothrombin variant Thrombosis and Haemostasis 79 706 708
23. Schulman S. Svenungsson E. Granqvist S. 1998 Anticardiolipin antibodies predict early recurrence of thromboembolism and death among patients with venous thromboembolism following anticoagulant therapy. Duration of Anticoagulation Study Group American Journal of Medicine 104 332 338
24. Schulman S. Wåhlander K. Lundström T. Billing Clason S. Eriksson H. for the THRIVE III Investigators 2003 Secondary prevention of venous thromboembolism with the oral direct thrombin inhibitor ximelagatran New England Journal of Medicine 349 1713 1721
25. SPORTIF Executive Steering Committee for the SPORTIF V Investigators 2005 Ximelagatran vs warfarin for stroke prevention in patients with nonvalvular atrial fibrillation: a randomized trial JAMA 293 690 698
26. Wåhlander K. Larson G. Lindahl T.L. Andersson C. Frison L. Gustafsson D. Bylock A. Eriksson B.I. 2002 Factor V Leiden (G1691A) and prothrombin gene G20210A mutations as potential risk factors for venous thromboembolism after total hip or total knee replacement surgery Thrombosis and Haemostasis 87 580 585
27. Wallentin L. Wilcox R.G. Weaver W.D. Emanuelsson H. Goodvin A. Nyström P. Bylock A. 2003 Oral ximelagatran for secondary prophylaxis after myocardial infarction: the ESTEEM randomised controlled trial Lancet 362 789 797
28. Weitz J.I. Middeldorp S. Geerts W. Heit J.A. 2004 Thrombophilia and new anticoagulant drugs Hematology (American Society of Hematology Education Program Book) 1 424 438