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

Ikuo Fukuda; Atsushi Hirayama; Kazuo Kawasugi; Takao Kobayashi; Hideaki Maeda; Mashio Nakamura; Norifumi Nakanishi; Norikazu Yamada; Tsubasa Tajima; Sanghun Iwashiro; Yutaka Okayama; Toshiyuki Sunaya; Kazufumi Hirano; Takanori Hayasaki

doi:10.1055/a-1664-1164

TH Open, Inhaltsverzeichnis

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^*

¹Department of Cardiovascular Surgery, Suita Tokushukai Hospital, Suita, Japan

,

Atsushi Hirayama^*

²Division of Cardiology, Osaka Police Hospital, Osaka, Japan

,

Kazuo Kawasugi

³Department of Internal Medicine, Teikyo University School of Medicine, Tokyo, Japan

,

Takao Kobayashi

⁴Hamamatsu Medical Center, Hamamatsu, Japan

,

Hideaki Maeda

⁵Division of Cardiovascular Surgery, Nihon University School of Medicine, Tokyo, Japan

,

Mashio Nakamura

⁶Nakamura Medical Clinic, Kuwana, Japan

,

Norifumi Nakanishi

⁷Department of Cardiology, Osaka Namba Clinic, Osaka, Japan

,

Norikazu Yamada

⁸Department of Cardiology, Kuwana City Medical Center, Kuwana, Japan

,

Tsubasa Tajima

⁹Medical Affairs Cardiovascular and Nephrology, Medical Affairs and Pharmacovigilance, Bayer Yakuhin, Ltd., Osaka, Japan

,

Sanghun Iwashiro

⁹Medical Affairs Cardiovascular and Nephrology, Medical Affairs and Pharmacovigilance, Bayer Yakuhin, Ltd., Osaka, Japan

,

Yutaka Okayama

¹⁰Pharmacovigilance Monitoring and Governance, Medical Affairs and Pharmacovigilance, Bayer Yakuhin, Ltd., Osaka, Japan

,

Toshiyuki Sunaya

¹¹Statistics and Data Insights, Data Sciences and Analytics, Research and Development Japan, Bayer Yakuhin, Ltd., Osaka, Japan

,

Kazufumi Hirano

¹⁰Pharmacovigilance Monitoring and Governance, Medical Affairs and Pharmacovigilance, Bayer Yakuhin, Ltd., Osaka, Japan

,

Takanori Hayasaki

⁹Medical Affairs Cardiovascular and Nephrology, Medical Affairs and Pharmacovigilance, Bayer Yakuhin, Ltd., Osaka, Japan

› Institutsangaben

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

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Referenzen

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