L. Bamber (1), M. Y. Wang (2), M. H. Prins (3), C. Ciniglio (4), R. Bauersachs (5), A. W. A. Lensing (1), S. J. Cano (6)
(1) Bayer Pharma AG, Wuppertal, Germany; (2) Bayer HealthCare, Montville, New Jersey, USA; (3) Maastricht University Medical Centre, Maastricht, The Netherlands; (4) Janssen Global Services, LLC, Raritan, New Jersey, USA; (5) Max Ratschow Clinic for Angiology, Darmstadt, Germany; (6) Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth, UK
Rivaroxaban, an oral, direct factor Xa inhibitor, has been approved for the treatment of deep-vein thrombosis (DVT) and pulmonary embolism (PE) and the prevention of recurrent DVT and PE as a fixed-dose, single-drug regimen that does not require initial heparinisation, routine coagulation monitoring or dose adjustment. This study evaluated patient-reported treatment satisfaction in EINSTEIN DVT – a large, open-label, randomised study that compared rivaroxaban with enoxaparin/vitamin K antagonist (VKA) therapy in patients with acute symptomatic DVT without PE. As part of EINSTEIN DVT, a total of 1,472 patients in seven countries were asked to complete a new, validated measure of treatment satisfaction – the Anti-Clot Treatment Scale (ACTS) – at scheduled visits throughout 12 months of treatment. ACTS scores were compared between study groups in the intention-to-treat population. Patients reported greater satisfaction in the rivaroxaban group compared with the enoxaparin/VKA group, with higher mean ACTS scores across visits. Mean ACTS Burdens scores were 55.2 vs 52.6 (p<0.0001) in favour of rivaroxaban, equivalent to a moderate effect size of 0.42. The treatment effect was consistent over time, with the mean score difference ranging from 2.18 (month 2) to 3.18 (month 12). Overall mean ACTS Benefits scores were 11.7 vs 11.5 in favour of rivaroxaban (p=0.006). This was associated with a small overall effect size of 0.12. The improvement in ACTS Benefits for rivaroxaban became apparent at month 2 and subsequent visits. Rivaroxaban results in improved treatment satisfaction compared with enoxaparin/VKA among patients with DVT, particularly in reducing patient-reported anticoagulation burden.
venous thromboembolism, rivaroxaban, PRO instruments, treatment satisfaction
William D. Fisher1, Bengt I. Eriksson2, Kenneth A. Bauer3, Lars Borris4, Ola E. Dahl5, Michael Gent6, Sylvia Haas7, Martin Homering8, Menno V. Huisman9, Ajay K. Kakkar10, Peter Kälebo2, Louis M. Kwong11, Frank Misselwitz8, Alexander G. G. Turpie6
Thromb Haemost 2007 97 6: 931-937
M. Monreal (1), K. Folkerts (2), A. Diamantopoulos (3), D. Imberti (4), M. Brosa (5)
Thromb Haemost 2013 110 5: 987-994
Single-dose TB-402 or rivaroxaban for the prevention of venous thromboembolism after total hip replacement
A randomised, controlled trial
See also Editorial by Dentali, Riva
P. Verhamme (1, 2), S. Gunn (3), E. Sonesson (4), K. Peerlinck (1, 2), T. Vanassche (1, 2), C. Vandenbriele (1, 2), W. Ageno (5), S. Glazer (4), M. Prins (6), H. Buller (7), M. Tangelder (3, 8)
Thromb Haemost 2013 109 6: 1091-1098
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