Oral rivaroxaban versus enoxaparin with vitamin K antagonist for the treatment of symptomatic venous thromboembolism in patients with cancer (EINSTEIN-DVT and EINSTEIN-PE): A pooled subgroup analysis of two randomised controlled trials

The Lancet Haematology

Volumn 1, Issue 1, 2014, Pages e37-e46

  Prins, Martin H ^a   Lensing, Anthonie W A ^b   Brighton, Tim A ^c   Lyons, Roger M ^d   Rehm, Jeffrey ^e   Trajanovic, Mila ^f   Davidson, Bruce L ^h   Beyer Westendorf, Jan ^g   Pap, Ákos F ^b   Berkowitz, Scott D ^f   Cohen, Alexander T ⁱ   Kovacs, Michael J ^j   Wells, Philip S ^k   Prandoni, Paolo ^l  

^a MAASTRICHT UNIVERSITY MEDICAL CENTER   (Netherlands)

^b BAYER PHARMA AG   (Germany)

^c PRINCE OF WALES HOSPITAL   (Australia)

^d Developmental Therapeutics Committee and Co Chair of the Genitourinary Committee   (United States)

^e Fredricksburg Orthopaedic Associates   (United States)

^f BAYER CORPORATION   (United States)

^g UNIVERSITY HOSPITAL CARL GUSTAV CARUS   (Germany)

^h UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

ⁱ GUY'S AND ST THOMAS' NHS FOUNDATION TRUST   (United Kingdom)

^j LONDON HEALTH SCIENCES CENTRE   (Canada)

^k OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

^l UNIVERSITY OF PADOVA   (Italy)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ACENOCOUMAROL; ANTIVITAMIN K; ENOXAPARIN; RIVAROXABAN; WARFARIN;

AGED; ARTICLE; BLEEDING; BRAIN CANCER; BREAST CANCER; COMPARATIVE STUDY; DIGESTIVE SYSTEM CANCER; DRUG EFFICACY; DRUG SAFETY; ENDOCRINE TUMOR; FEMALE; FOLLOW UP; HEMATOLOGIC MALIGNANCY; HUMAN; KIDNEY FUNCTION; LUNG CANCER; MAJOR CLINICAL STUDY; MALE; MEDICAL HISTORY; MORTALITY; NEOPLASM; OPEN STUDY; OUTCOME ASSESSMENT; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECURRENT DISEASE; SKIN CANCER; UROGENITAL TRACT CANCER; VENOUS THROMBOEMBOLISM; WEIGHT REDUCTION;

EID: 84922032437     PISSN: None     EISSN: 23523026     Source Type: Journal    
DOI: 10.1016/S2352-3026(14)70018-3     Document Type: Article

References (25)

1. The EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010; 363: 2499-510.
2. The EINSTEIN-PE Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med 2012; 366: 1287-97.
3. Prins MH, Lensing AWA. Derivation of the non-inferiority margin for the evaluation of direct oral anticoagulants in the treatment of venous thromboembolism. Thromb J 2013; 11: 13.
4. Prins MH, Lensing AWA, Bauersachs R, et al. Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies. Thromb J 2013; 11: 21.
5. Büller HR, Davidson BL, Decousus H, et al. Fondaparinux or enoxaparin for the initial treatment of symptomatic deep venous thrombosis: a randomized trial. Ann Intern Med 2004; 140: 867-73.
6. The Matisse Investigators. Subcutaneous fondaparinux versus intravenous unfractionated heparin in the initial treatment of pulmonary embolism. N Engl J Med 2003; 349: 1695-702.
7. The van Gogh Investigators. Idraparinux versus standard therapy for venous thromboembolic disease. N Engl J Med 2007; 357: 1094-104.
8. Prandoni P, Lensing AWA, Büller HR, et al. Deep-vein thrombosis and the incidence of subsequent symptomatic cancer. N Engl J Med 1992; 327: 1128-33.
9. Monreal M, Fernandez-Llamazares J, Perandreu J, Urrutia A, Sahuquillo JC, Contel E. Occult cancer in patients with venous thromboembolism: which patients, which cancers. Thromb Haemost 1997; 78: 1316-18.
10. Prins MH, Hettiarachchi RJ, Lensing AWA, Hirsh J. Newly diagnosed malignancy in patients with venous thromboembolism. Search or wait and see? Thromb Haemost 1997; 78: 121-25.
11. Prandoni P, Lensing AWA, Piccioli A, et al. Recurrent venous thromboembolism and bleeding complications during anticoagulant treatment in patients with cancer and venous thrombosis. Blood 2002; 100: 3484-88.
12. Hutten BA, Prins MH, Gent M, Ginsberg J, Tijssen JG, Büller HR. Incidence of recurrent thromboembolic and bleeding complications among patients with venous thromboembolism in relation to both malignancy and achieved international normalized ratio: a retrospective analysis. J Clin Oncol 2000; 18: 3078-83.
13. Akl EA, Barba M, Rohilla S, et al. Anticoagulation for the long term treatment of venous thromboembolism in patients with cancer. Cochrane Database Syst Rev 2008: CD006650.
14. Geerts WH, Bergqvist D, Pineo GF, et al. Prevention of venous thromboembolism: American College of Chest Physicians evidencebased clinical practice guidelines (8th Edition). Chest 2008; 133: 381S-453S.
15. Lee AY, Levine MN, Baker RI, et al. Low-molecular-weight heparin versus a coumarin for the prevention of recurrent venous thromboembolism in patients with cancer. N Engl J Med 2003; 349: 146-53
16. Hull RD, Pineo GF, Brant RF, et al. Long-term low-molecularweight heparin versus usual care in proximal-vein thrombosis patients with cancer. Am J Med 2006; 119: 1062-72.
17. Deitcher SR, Kessler CM, Merli G, Rigas JR, Lyons RM, Fareed J. Secondary prevention of venous thromboembolic events in patients with active cancer: enoxaparin alone versus initial enoxaparin followed by warfarin for a 180-day period. Clin Appl Thromb Hemost 2006; 12: 389-96.
18. Meyer G, Marjanovic Z, Valcke J, et al. Comparison of low-molecular-weight heparin and warfarin for the secondary prevention of venous thromboembolism in patients with cancer: a randomized controlled study. Arch Intern Med 2002; 162: 1729-35.
19. Bauersachs RM, Lensing AWA, Prins MH, et al. Rivaroxaban versus enoxaparin/vitamin K antagonist therapy in patients with venous thromboembolism and renal impairment. Thromb J (in press).
20. Kubitza D, Becka M, Voith B, Zuehlsdorf M, Wensing G. Safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59-7939, an oral, direct Factor Xa inhibitor. Clin Pharmacol Ther 2005; 78: 412-21.
21. Kubitza D, Becka M, Wensing G, Voith B, Zuehlsdorf M. Safety, pharmacodynamics, and pharmacokinetics of BAY 59-7939 -an oral, direct factor Xa inhibitor -after multiple dosing in healthy male subjects. Eur J Clin Pharmacol 2005; 61: 873-80.
22. Mueck W, Stampfuss J, Kubitza D, Becka M. Clinical pharmacokinetic and pharmacodynamic profile of rivaroxaban. Clin Pharmacokinet 2014; 53: 1-16.
23. Seaman S, Nelson A, Noble S. Cancer-associated thrombosis, lowmolecular-weight heparin, and the patient experience: a qualitative study. Patient Prefer Adherence 2014; 8: 453-61.
24. Bamber L, Wang MY, Prins MH, et al. Patient-reported treatment satisfaction with oral rivaroxaban versus standard therapy in the treatment of acute symptomatic deep-vein thrombosis. Thromb Haemost 2013; 110: 732-41.
25. Prins M, Bamber L, Cano S, Wang M, Lensing AWA, Bauersachs R. Patient-reported treatment satisfaction with oral rivaroxaban versus standard therapy in the treatment of acute symptomatic pulmonary embolism. Blood (ASH Annual Meeting Abstracts) 2012; 120 (suppl): abstr 1163.