G. Raskob (1), A. T. Cohen (2), B. I. Eriksson (3), D. Puskas (4), M. Shi (5), T. Bocanegra (5), J. I. Weitz (6)
(1) College of Public Health, The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA; (2) King’s College Hospital, London, UK; (3) Sahlgrenska University Hospital; (4) Thunder Bay Regional Hospital, Thunder Bay, Ontario, Canada; (5) Daiichi Sankyo Pharma Development, Edison, New Jersey, USA; (6) McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, Ontario, Canada
Edoxaban is a new oral direct factor Xa inhibitor. The purpose of this study was to evaluate the efficacy and safety of different doses of edoxaban for the prevention of venous thromboembolism (VTE) in patients undergoing elective total hip replacement. A total of 903 patients were randomised to oral edoxaban 15, 30, 60 or 90 mg once daily or subcutaneous dalteparin once daily (initial dose 2,500 IU, subsequent doses 5,000 IU). Both drugs were begun 6–8 hours postoperatively and continued for 7–10 days, when bilateral venography was performed. The primary efficacy endpoint was the incidence of total VTE, which included proximal and/or distal deep-vein thrombosis (DVT) by venography or symptomatic, objectively confirmed DVT or pulmonary embolism during the treatment period. The primary safety outcome was the incidence of the composite of major and clinically relevant non-major bleeding. All venograms and bleeding events were reviewed by a central independent adjudication committee blinded as to treatment allocation. Of the 903 patients randomised, 776 were evaluable for the primary efficacy analysis. The incidences of VTE were 28.2%, 21.2%, 15.2%, and 10.6% in patients receiving edoxaban 15, 30, 60 and 90 mg, respectively, compared with 43.8% in the dalteparin group (p<0.005 ). There was a statistically significant (p<0.001) dose-response for efficacy across the edoxaban dose groups for total VTE and for major VTE. The incidence of clinically relevant bleeding was low and similar across the groups. Oral edoxaban once daily is effective for preventing VTE after total hip replacement.
thromboprophylaxis, venous thromboembolism, Factor Xa inhibitor, anticoagulant therapy, edoxaban
S. Rohatagi (1), J. Mendell (2), H. Kastrissios (3), M. Green (3), M. Shi (2), I. Patel (2), D. E. Salazar (2)
Thromb Haemost 2012 108 5: 887-895
Urs Kistler1, Inès Kramers-de Quervain2, Urs Munzinger3, Nils Kucher4
Thromb Haemost 2008 99 6: 1049-1052
R. M. Bauersachs
Hämostaseologie 2008 28 1: 21-26
Patients receiving oral anticoagulants should be carefully managed to minimize the risk of bleeding...
Acquired haemophilia A (AHA) is a rare but often severe bleeding disorder caused by ...
Section III " Vitamin K antagonists in heart disease: Current status and perspectives" of...