Fukuda Ikuo, Hirayama Atsushi, Kawasugi Kazuo, Kobayashi Takao, Maeda Hideaki, Nakamura Mashio, Nakanishi Norifumi, Yamada Norikazu, Tajima Tsubasa, Iwashiro Sanghun, Okayama Yutaka, Sunaya Toshiyuki, Hirano Kazufumi, Hayasaki Takanori
Department of Cardiovascular Surgery, Suita Tokushukai Hospital, Suita, Japan.
Division of Cardiology, Osaka Police Hospital, Osaka, Japan.
TH Open. 2021 Oct 7;5(4):e521-e532. doi: 10.1055/a-1664-1164. eCollection 2021 Oct.
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. XASSENT will evaluate rivaroxaban treatment of VTE in real-world Japanese clinical practice. We report the study design and baseline patient characteristics. 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. Baseline patient characteristics at June 2020 ( = 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'. Results from XASSENT will complement phase 3 trial data and inform clinical practice.
利伐沙班的疗效和安全性已在静脉血栓栓塞症（VTE；肺栓塞[PE]和深静脉血栓形成[DVT]）患者的3期试验中得到证实。关于利伐沙班在日本常规临床实践中治疗VTE的数据仍然有限。XASSENT将评估利伐沙班在日本真实临床实践中对VTE的治疗效果。我们报告该研究的设计和患者基线特征。XASSENT（NCT02558465）是一项开放标签、前瞻性观察性上市后监测队列研究，针对接受利伐沙班治疗VTE的患者。入组时间为2015年11月至2018年3月。XASSENT将对患者进行长达2年的随访。主要结局变量：大出血和有症状的复发性VTE。统计分析为探索性和描述性分析。呈现了2020年6月时的患者基线特征（n = 2299）（女性占58.2%；平均年龄66.7岁；平均体重60.9 kg）。该人群包括具有广泛特征的患者，如年龄较大、体重较轻和肾功能不全。大多数参与者（67.6%）在基线时有VTE危险因素史。一半的人群（50.4%）仅患有DVT；41.4%患有DVT合并PE；8.2%仅患有PE。总体而言，68.4%为住院患者，77.1%有症状性VTE。84.6%的患者接受利伐沙班初始治疗，15.4%接受维持治疗。在日本，大多数患者接受批准剂量的利伐沙班进行VTE的初始治疗（每日30 mg；84.4%）或维持治疗（每日15 mg；81.9%）。选择非推荐剂量的最常见原因是“年龄较大”。XASSENT的结果将补充3期试验数据并为临床实践提供参考。
