CC-BY 4.0 · TH Open 2018; 02(02): e139-e146
DOI: 10.1055/s-0038-1641679
Original Article
Georg Thieme Verlag KG Stuttgart · New York

Patient-Reported Treatment Experience with Oral Rivaroxaban: Results from the Noninterventional XALIA Study of Deep-Vein Thrombosis

Stefan Cano
1  Modus Outcomes, Letchworth Garden City, United Kingdom
,
Lorenzo Mantovani
2  CESP-Center for Public Health Research, University of Milan Bicocca, Monza, Italy
,
Kerstin Folkerts
3  Bayer AG, Wuppertal, Germany
,
Martin Gebel
3  Bayer AG, Wuppertal, Germany
,
Kurtulus Sahin
4  ClinStat GmbH, Cologne, Germany
,
Elizabeth Zell
5  Stat-Epi Associates, Inc., Ponte Vedra Beach, Florida, United States
,
Danja Monje
6  Bayer AG, Berlin, Germany
,
Jonas Schneider
6  Bayer AG, Berlin, Germany
,
Martin van Eickels
6  Bayer AG, Berlin, Germany
,
Sylvia Haas
7  Vascular Centre, Munich, Germany
,
Reinhold Kreutz
8  Institute of Clinical Pharmacology and Toxicology, Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany
,
Walter Ageno
9  Department of Clinical and Experimental Medicine, University of Insubria, Varese, Italy
,
Alexander G. G. Turpie
10  Department of Medicine, Hamilton Health Sciences, Hamilton, Ontario, Canada
› Author Affiliations
Funding Editorial assistance was supported by Bayer AG and Janssen Scientific Affairs, LLC.

Trial Registration Number NCT01619007.
Further Information

Publication History

29 September 2017

19 February 2018

Publication Date:
11 April 2018 (online)

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.

Authors' Contributions

S.C. created the initial draft of this report. K.S., L.M., K.F., A.G.G.T., S.H., R.K., J.S., M.v.E., and W.A. provided input into the content and direction of the manuscript. M.G. performed the statistical analyses and E.Z. did the propensity score design. D.M. was responsible for data management. All authors had full access to the source data and participated in writing and reviewing the report and accept full responsibility for its overall content.


Supplementary Material