title: Patient-reported treatment satisfaction with oral rivaroxaban versus standard therapy in the treatment of acute symptomatic deep-vein thrombosis.
abstract: 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.
authors.affiliation: Dr. Stefan Cano, PhD, Clinical Neurology Research Group, Plymouth University Peninsula Schools of Medicine and Dentistry, Room N16 ITTC Building, Tamar Science Park, Davy Road, Plymouth, Devon PL6 8BX, UK, Tel.: +44 1752 315272, Fax: +44 1752 315254, E-mail: stefan.cano@pcmd.ac.uk.
authors.forename: Luke
authors.initials: L
authors.lastname: Bamber
authors.forename: Maria Y
authors.initials: MY
authors.lastname: Wang
authors.forename: Martin H
authors.initials: MH
authors.lastname: Prins
authors.forename: Cathleen
authors.initials: C
authors.lastname: Ciniglio
authors.forename: Rupert
authors.initials: R
authors.lastname: Bauersachs
authors.forename: Anthonie W A
authors.initials: AW
authors.lastname: Lensing
authors.forename: Stefan J
authors.initials: SJ
authors.lastname: Cano
mesh_terms: D000208:Acute Disease; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D017984:Enoxaparin / Q000008:administration & dosage* / Q000009:adverse effects; D065427:Factor Xa Inhibitors; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage* / Q000009:adverse effects; D017060:Patient Satisfaction; D000069552:Rivaroxaban; D013876:Thiophenes / Q000008:administration & dosage* / Q000009:adverse effects; D020246:Venous Thrombosis / Q000188:drug therapy*
chemical_list: D000925:Anticoagulants; D017984:Enoxaparin; D065427:Factor Xa Inhibitors; D009025:Morpholines; D013876:Thiophenes; D000069552:Rivaroxaban
keywords: PRO instruments; rivaroxaban; treatment satisfaction; venous thromboembolism