Abstract
For venous thromboembolism (VTE) treatment, patient satisfaction was shown to improve with rivaroxaban versus standard anticoagulation in the phase III EINSTEIN DVT and EINSTEIN PE trials. This substudy of the prospective, noninterventional XALIA study of rivaroxaban for deep-vein thrombosis treatment assessed if this was also observed in routine clinical practice. Patients enrolled in XALIA who received rivaroxaban or standard anticoagulation treatment were eligible for inclusion in this substudy. Treatment decisions were at the physician's discretion. Patients completed the 17-item Anti-Clot Treatment Scale (ACTS, comprising a 12-item Burdens subscale, a 3-item Benefits subscale and one global item per subscale) during follow-up. The propensity score-matched set (PMS) was used for the main analysis; the adjusted safety analysis (ASAF) set was used for confirmatory purposes. Analyses by follow-up visit and subgroup, including age, sex, and previous VTE, were also conducted. The PMS-ACTS analysis included 458 rivaroxaban-treated and 434 standard anticoagulation-treated patients. Baseline demographic and clinical characteristics were generally similar across treatment arms. ACTS Burdens scores significantly improved with rivaroxaban versus standard anticoagulation (least-squares mean difference of 2.4 ± 0.4 points; p < 0.0001); ACTS Benefits scores were numerically higher with rivaroxaban (least-squares mean difference of 0.2 ± 0.1 points; p = 0.2). Similar findings occurred across follow-up visits and subgroups. Results were confirmed in the ASAF-ACTS analysis. Consistent with phase III analyses, rivaroxaban was associated with improved ACTS Burdens scores; ACTS Benefits scores numerically favored rivaroxaban, although without reaching statistical significance.
Highlights
Anticoagulant treatment for venous thromboembolism (VTE), comprising deep-vein thrombosis (DVT) and pulmonary embolism (PE), is associated with various benefits and burdens, some of which are therapy specific
This left an adjusted safety analysis (ASAF) set of 4,515 patients, 2,505 (55.5%) of who received rivaroxaban and 2,010 (44.5%) who received standard anticoagulation
The results demonstrated that patients given rivaroxaban had an improved treatment experience, both overall and across study time points, in terms of finding the treatment less burdensome than standard anticoagulation
Summary
Anticoagulant treatment for venous thromboembolism (VTE), comprising deep-vein thrombosis (DVT) and pulmonary embolism (PE), is associated with various benefits and burdens, some of which are therapy specific. Vitamin K antagonists (VKAs) require regular anticoagulation monitoring, which contributes to making their use in the outpatient setting suboptimal. The interaction of VKAs with foods containing high levels of vitamin K, other medications, and alcohol contributes to the need for monitoring and management of adverse effects, making their use more burdensome.[4] VKAs have slow and variable onsets of action, and there is considerable variation between individuals in terms of their response to therapy. Other concerns associated with anticoagulation treatment may adversely affect patients’ attitudes toward therapy, for example, the perceived risk of bleeding events
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callMore From: TH open : companion journal to thrombosis and haemostasis
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
