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CC BY 4.0 · TH Open 2021; 05(04): e521-e532
DOI: 10.1055/a-1664-1164
Original Article

Design and Baseline Data for a Prospective Observational Study of Rivaroxaban in Patients with Venous Thromboembolism in Japan (XASSENT)

Ikuo Fukuda   *
1   Department of Cardiovascular Surgery, Suita Tokushukai Hospital, Suita, Japan
,
Atsushi Hirayama   *
2   Division of Cardiology, Osaka Police Hospital, Osaka, Japan
,
Kazuo Kawasugi
3   Department of Internal Medicine, Teikyo University School of Medicine, Tokyo, Japan
,
Takao Kobayashi
4   Hamamatsu Medical Center, Hamamatsu, Japan
,
Hideaki Maeda
5   Division of Cardiovascular Surgery, Nihon University School of Medicine, Tokyo, Japan
,
Mashio Nakamura
6   Nakamura Medical Clinic, Kuwana, Japan
,
Norifumi Nakanishi
7   Department of Cardiology, Osaka Namba Clinic, Osaka, Japan
,
Norikazu Yamada
8   Department of Cardiology, Kuwana City Medical Center, Kuwana, Japan
,
Tsubasa Tajima
9   Medical Affairs Cardiovascular and Nephrology, Medical Affairs and Pharmacovigilance, Bayer Yakuhin, Ltd., Osaka, Japan
,
Sanghun Iwashiro
9   Medical Affairs Cardiovascular and Nephrology, Medical Affairs and Pharmacovigilance, Bayer Yakuhin, Ltd., Osaka, Japan
,
Yutaka Okayama
10   Pharmacovigilance Monitoring and Governance, Medical Affairs and Pharmacovigilance, Bayer Yakuhin, Ltd., Osaka, Japan
,
Toshiyuki Sunaya
11   Statistics and Data Insights, Data Sciences and Analytics, Research and Development Japan, Bayer Yakuhin, Ltd., Osaka, Japan
,
Kazufumi Hirano
10   Pharmacovigilance Monitoring and Governance, Medical Affairs and Pharmacovigilance, Bayer Yakuhin, Ltd., Osaka, Japan
,
Takanori Hayasaki
9   Medical Affairs Cardiovascular and Nephrology, Medical Affairs and Pharmacovigilance, Bayer Yakuhin, Ltd., Osaka, Japan
› Author Affiliations Funding Bayer Yakuhin, Ltd.
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Abstract

Background The efficacy and safety of rivaroxaban have been demonstrated in phase 3 trials of patients with venous thromboembolism (VTE; pulmonary embolism [PE] and deep vein thrombosis [DVT]). Data regarding rivaroxaban treatment of VTE in routine Japanese clinical practice remain limited.

Objectives XASSENT will evaluate rivaroxaban treatment of VTE in real-world Japanese clinical practice. We report the study design and baseline patient characteristics.

Methods XASSENT (NCT02558465) is an open-label, prospective observational, post-marketing surveillance cohort study in patients receiving rivaroxaban treatment for VTE. Enrolment took place between November 2015 and March 2018. XASSENT will follow patients for up to 2 years. Primary outcome variables: major bleeding and symptomatic recurrent VTE. Statistical analyses are exploratory and descriptive.

Results Baseline patient characteristics at June 2020 (n = 2,299) are presented (58.2% female; mean age 66.7 years; mean weight 60.9 kg). The population encompasses patients with wide-ranging characteristics including older age, low weight, and renal dysfunction. Most participants (67.6%) had a history of VTE risk factors at baseline. Half of the population (50.4%) had DVT only; 41.4% had DVT with PE; 8.2% had PE only. Overall, 68.4% were inpatients and 77.1% had symptomatic VTE. Rivaroxaban was prescribed for initial treatment in 84.6% of patients and maintenance treatment in 15.4%. Most were prescribed the approved dose of rivaroxaban for initial (30 mg daily; 84.4%) or maintenance (15 mg daily; 81.9%) treatment of VTE in Japan. The most common reason for selecting non-recommended dose was ‘elderly’.

Conclusions Results from XASSENT will complement phase 3 trial data and inform clinical practice.

Keywords

Japan - pulmonary embolism - rivaroxaban - venous thromboembolism - venous thrombosis

Addendum

I.F., A.H., K.K., T.K., H.M., M.N., N.N., N.Y., Y.O. and T.S. contributed to developing protocol, study execution, data analysis, interpretation of results, and editing the manuscript. T.T., S.I., K.H., T.H. contributed to data analysis, interpretation of the results, and drafting/editing the manuscript. The manuscript has been read and approved for submission to the TH Open by all authors.


Prior Presentation

None.


* Co-first authors.




Publication History

Received: 26 May 2021

Accepted: 01 October 2021

Accepted Manuscript online:
07 October 2021

Article published online:
02 December 2021

© 2021. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

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