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

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....

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Autores principales:	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
Formato:	article
Lenguaje:	EN
Publicado:	Georg Thieme Verlag KG 2021
Materias:	japan pulmonary embolism rivaroxaban venous thromboembolism venous thrombosis Diseases of the circulatory (Cardiovascular) system RC666-701
Acceso en línea:	https://doaj.org/article/313ff2ce01f142e49eb686e8b2f02342
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spelling	oai:doaj.org-article:313ff2ce01f142e49eb686e8b2f023422021-12-03T00:14:09ZDesign and Baseline Data for a Prospective Observational Study of Rivaroxaban in Patients with Venous Thromboembolism in Japan (XASSENT)2512-946510.1055/a-1664-1164https://doaj.org/article/313ff2ce01f142e49eb686e8b2f023422021-10-01T00:00:00Zhttp://www.thieme-connect.de/DOI/DOI?10.1055/a-1664-1164https://doaj.org/toc/2512-9465Background 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.Ikuo FukudaAtsushi HirayamaKazuo KawasugiTakao KobayashiHideaki MaedaMashio NakamuraNorifumi NakanishiNorikazu YamadaTsubasa TajimaSanghun IwashiroYutaka OkayamaToshiyuki SunayaKazufumi HiranoTakanori HayasakiGeorg Thieme Verlag KGarticlejapanpulmonary embolismrivaroxabanvenous thromboembolismvenous thrombosisDiseases of the circulatory (Cardiovascular) systemRC666-701ENTH Open, Vol 05, Iss 04, Pp e521-e532 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	japan pulmonary embolism rivaroxaban venous thromboembolism venous thrombosis Diseases of the circulatory (Cardiovascular) system RC666-701
spellingShingle	japan pulmonary embolism rivaroxaban venous thromboembolism venous thrombosis Diseases of the circulatory (Cardiovascular) system RC666-701 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 Design and Baseline Data for a Prospective Observational Study of Rivaroxaban in Patients with Venous Thromboembolism in Japan (XASSENT)
description	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.
format	article
author	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
author_facet	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
author_sort	Ikuo Fukuda
title	Design and Baseline Data for a Prospective Observational Study of Rivaroxaban in Patients with Venous Thromboembolism in Japan (XASSENT)
title_short	Design and Baseline Data for a Prospective Observational Study of Rivaroxaban in Patients with Venous Thromboembolism in Japan (XASSENT)
title_full	Design and Baseline Data for a Prospective Observational Study of Rivaroxaban in Patients with Venous Thromboembolism in Japan (XASSENT)
title_fullStr	Design and Baseline Data for a Prospective Observational Study of Rivaroxaban in Patients with Venous Thromboembolism in Japan (XASSENT)
title_full_unstemmed	Design and Baseline Data for a Prospective Observational Study of Rivaroxaban in Patients with Venous Thromboembolism in Japan (XASSENT)
title_sort	design and baseline data for a prospective observational study of rivaroxaban in patients with venous thromboembolism in japan (xassent)
publisher	Georg Thieme Verlag KG
publishDate	2021
url	https://doaj.org/article/313ff2ce01f142e49eb686e8b2f02342
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Design and Baseline Data for a Prospective Observational Study of Rivaroxaban in Patients with Venous Thromboembolism in Japan (XASSENT)

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