Efficacy and safety of edoxaban versus enoxaparin for the prevention of venous thromboembolism following total hip arthroplasty: STARS J-V

Thrombosis Journal

Volumn 13, Issue 1, 2015, Pages

  Fuji, Takeshi ^a   Fujita, Satoru ^b   Kawai, Yohko ^c   Nakamura, Mashio ^d   Kimura, Tetsuya ^e   Fukuzawa, Masayuki ^e   Abe, Kenji ^e   Tachibana, Shintaro ^f  

^a OSAKA KOSEI NENKIN HOSPITAL   (Japan)

^b Takarazuka Daiichi Hospital   (Japan)

^c INTERNATIONAL UNIVERSITY OF HEALTH AND WELFARE   (Japan)

^d MIE UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^e DAIICHI SANKYO CO   (Japan)

^f Mishuku Hospital   (Japan)

Author keywords

Edoxaban; Enoxaparin; Factor Xa; Thromboprophylaxis; Total hip arthroplasty

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; EDOXABAN; ENOXAPARIN; GAMMA GLUTAMYLTRANSFERASE;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; COMPARATIVE EFFECTIVENESS; COMPRESSION THERAPY; CONJUNCTIVAL HEMORRHAGE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; DUODENAL ULCER BLEEDING; EPISTAXIS; FEMALE; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; GASTROINTESTINAL HEMORRHAGE; HEMARTHROSIS; HEMATOMA; HEMATURIA; HIP ARTHROPLASTY; HUMAN; JAPAN; LIVER DYSFUNCTION; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; OUTCOME ASSESSMENT; PHASE 3 CLINICAL TRIAL; PHLEBOGRAPHY; PHYSIOTHERAPY; POSTPROCEDURAL HEMATOMA; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SUBCUTANEOUS HEMORRHAGE; THROMBOSIS PREVENTION; VENOUS THROMBOEMBOLISM; WOUND HEMORRHAGE;

EID: 84938889688     PISSN: None     EISSN: 14779560     Source Type: Journal    
DOI: 10.1186/s12959-015-0057-x     Document Type: Article

References (24)

1. Mavrakanas T, Bounameaux H. The potential role of new oral anticoagulants in the prevention and treatment of thromboembolism. Pharmacol Ther. 2011;130:46-58.
2. Geerts WH, Bergqvist D, Pineo GF, Heit JA, Samama CM, Lassen MR, et al. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;133:381S-453.
3. Falck-Ytter Y, Francis CW, Johanson NA, Curley C, Dahl OE, Schulman S, et al. 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:e278S-325.
4. JCS Joint Working Group. Guidelines for the diagnosis, treatment and prevention of pulmonary thromboembolism and deep vein thrombosis (JCS 2009). Circ J. 2011;75:1258-81.
5. Committee for revision of the Japanese guidelines for prevention of venous thromboembolism, the Japanese Orthopaedic Association. Guidelines for Prevention of Venous Thromboembolism by the Japanese Orthopeaedic Association [in Japanse]. Tokyo: Nankodo Co., Ltd; 2008.
6. Fuji T, Ochi T, Niwa S, Fujita S. Prevention of postoperative venous thromboembolism in Japanese patients undergoing total hip or knee arthroplasty: two randomized, double-blind, placebo-controlled studies with three dosage regimens of enoxaparin. J Orthop Sci. 2008;13:442-51.
7. Fuji T, Fujita S, Ochi T. Fondaparinux prevents venous thromboembolism after joint replacement surgery in Japanese patients. Int Orthop. 2008;32:443-51.
8. Furugohri T, Isobe K, Honda Y, Kamisato-Matsumoto C, Sugiyama N, Nagahara T, et al. DU-176b, a potent and orally active factor Xa inhibitor: in vitro and in vivo pharmacological profiles. J Thromb Haemost. 2008;6:1542-9.
9. Fuji T, Fujita S, Tachibana S, Kawai Y. A dose-ranging study evaluating the oral factor Xa inhibitor edoxaban for the prevention of venous thromboembolism in patients undergoing total knee arthroplasty. J Thromb Haemost. 2010;8:2458-68.
10. Raskob G, Cohen AT, Eriksson BI, Puskas D, Shi M, Bocanegra T, et al. Oral direct factor Xa inhibition with edoxaban for thromboprophylaxis after elective total hip replacement. A randomised double-blind dose-response study. Thromb Haemost. 2010;104:642-9.
11. Fuji T, Wang C-J, Fujita S, Tachibana S, Kawai Y. Edoxaban in patients undergoing total hip arthroplasty: a phase IIb dose-finding study [Abstract]. Blood. 2009;114:2098.
12. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16:31-41.
13. Farrington CP, Manning G. Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk. Stat Med. 1990;9:1447-54.
14. Editorial committee on Japanese guidelines for prevention of venous thromboembolism. Japanese Guidelines for Prevention of Venous Thromboembolism [in Japanese]. (Ver.1) Tokyo: Medical Front International Limited; 2004.
15. Fuji T, Wang CJ, Fujita S, Kawai Y, Kimura T, Tachibana S. Safety and efficacy of edoxaban, an oral factor Xa inhibitor, for thromboprophylaxis after total hip arthroplasty in Japan and Taiwan. Thromb Res. 2014;134:1198-204.
16. Nagase Y, Yasunaga H, Horiguchi H, Hashimoto H, Shoda N, Kadona Y, et al. Risk factors for pulmonary embolism and the effects of fondaparinux after total hip and knee arthroplasty: a retrospective observational study with use of a national database in Japan. J Bone Joint Surg Am. 2011;93, e146.
17. Rohatagi S, Mendell J, Kastrissios H, Green M, Shi M, Patel I, et al. Characterisation of exposure versus response of edoxaban in patients undergoing total hip replacement surgery. Thromb Haemost. 2012;108:887-95.
18. Eriksson BI, Rosencher N, Friedman RJ, Homering M, Dahl OE. Concomitant use of medication with antiplatelet effects in patients receiving either rivaroxaban or enoxaparin after total hip or knee arthroplasty. Thromb Res. 2012;130:147-51.
19. Strebel N, Prins M, Agnelli G, Buller HR. Preoperative or postoperative start of prophylaxis for venous thromboembolism with low-molecular-weight heparin in elective surgery? Arch Intern Med. 2002;162(13):1451-6.
20. Carlson MK, Gleason PP, Sen S. Elevation of hepatic transaminases after enoxaparin use: case report and review of unfractionated and low-molecular-weight heparin-induced hepatotoxicity. Pharmacotherapy. 2001;21:108-13.
21. Eriksson BI, Borris LC, Friedman RJ, Haas S, Huisman MV, Kakkar AK, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008;358:2765-75.
22. Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, et al. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet. 2007;370:949-56.
23. Lassen MR, Gallus A, Raskob GE, Pineo G, Chen D, Ramirez LM. ADVANCE-3 investigators. Apixaban versus enoxaparin for thromboprophylaxis after hip replacement. N Engl J Med. 2010;363:2487-98.
24. Lovenox® (enoxaparin sodium injection) for subcutaneous and intravenous use. [Package insert]. Sanofi-Aventis U.S. LLC, Bridgewater NJ. 2013.