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Poster Networking

Venous Thromboembolism

PB0391 - XAPEC: A Real-World, Prospective, Multicenter, Observational Cohort Field Study of Patients with Pulmonary Embolism Treated with Rivaroxaban in China

Sunday, June 23, 2024
13:45 – 14:45 ICT
Room: Exhibition Hall

    Presenting Author(s)

  • Zhenguo Zhai, MD,PhD

    professor
    China-Japan Friendship Hospital, Beijing, China; National Clinical Research Center for Respiratory Diseases, Beijing, China
    Beijing, Beijing, China (People's Republic)

    • Co-Author(s)

  • QG

    Qian Gao

    Associate Professor
    China-Japan Friendship Hospital, Beijing, China; National Clinical Research Center for Respiratory Diseases, Beijing, China
    Beijing, Beijing, China (People's Republic)

  • YY

    Yadong Yuan

    Professor
    The Second Hospital of Hebei Medical University, Shijiazhuang, China
    Beijing, Beijing, China (People's Republic)

  • CL

    Chunli Liu

    Professor
    The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China
    Guangzhou, Guangdong, China (People's Republic)

  • YM

    Yuhong Mi

    Professor
    Beijing Anzhen Hospital, Capital Medical University, Beijing, China
    Beijing, Beijing, China (People's Republic)

  • WZ

    Weihua Zhang

    Professor
    The First Hospital of Jilin University, Changchun, China
    Changchun, Jilin, China (People's Republic)

  • YT

    Yongjun Tang

    Professor
    Xiangya Hospital Central South University, Changsha, China.
    Changsha, Hunan, China (People's Republic)

  • YY

    Yuanhua Yang

    Professor
    Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China; Beijing Institute of Respiratory Medicine, Beijing, China.
    Beijing, Beijing, China (People's Republic)

  • JZ

    Jie Zhang

    Professor
    The Second Hospital of Jilin University, Changchun, China
    Changchun, Jilin, China (People's Republic)

  • xX

    xiaomao Xu

    Professor
    Beijing Hospital, Beijing, China
    Beijing, Beijing, China (People's Republic)

  • KY

    Kejing Ying

    Professor
    Sir Run-Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China
    Hangzhou, Zhejiang, China (People's Republic)

  • WX

    Weiping Xie

    Professor
    The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
    Beijing, Beijing, China (People's Republic)

  • XY

    Xiaohong Yang

    Professor
    People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China
    Urumqi, Xinjiang, China (People's Republic)

  • JZ

    Jianping Zhao

    Professor
    Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
    Wuhan, Hubei, China (People's Republic)

  • jK

    jiulong Kuang

    Professor
    he Second Affiliated Hospital of Nanchang University, Nanchang, China.
    Nanchang, Jiangxi, China (People's Republic)

  • Jl

    Jinming liu

    Professor
    Department of Pulmonary Circulation, Shanghai Pulmonary Hospital， Shanghai, China.
    Shanghai, Shanghai, China (People's Republic)

  • JT

    Jiazina Tuohayi

    Professor
    The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China
    Urumqi, Xinjiang, China (People's Republic)

  • SL

    Sha Li

    Associate Director, Medical Affairs
    Bayer Health Care, Beijing, China.
    Beijing, Beijing, China (People's Republic)

  • DW

    Di Wei

    Lead Medical Affairs Statistician
    Bayer Health Care, Beijing, China.
    Beijing, Beijing, China (People's Republic)

  • CW

    Chen Wang

    President of Chinese Academy of Medical Sciences & Peking Union Medical College
    Chinese Academy of Medical Sciences & Peking Union Medical College
    Beijing, Beijing, China (People's Republic)

Background: Although rivaroxaban is recommended by guidelines for secondary prevention in patients with pulmonary embolism (PE) based on clinical trial results, safety and effectiveness data from unselected Chinese population in routine clinical practice were limited.

Aims: To investigate the safety and effectiveness of rivaroxaban in Chinese real-world clinical practice.

Methods: XAPEC is a single-arm prospective non-interventional observational cohort study, patients planned for at least 3 months of rivaroxaban treatment for acute PE were recruited from 16 sites in China, all patients were followed up for 12 months. Eligible patients were adults (aged ≥18 years) with an objectively confirmed diagnosis of acute symptomatic or asymptomatic PE, and an indication to receive anticoagulation treatment for at least 3 months. The primary endpoint was adjudicated major bleeding.

Results: From February 2018 through July 2021, 300 patients were enrolled and 292 were included in analysis. 243 (83.2%) patients had two or more embolisms, 167 (57.2%) had concurrent deep-vein thrombosis (DVT), 64 (21.9%) patients present with high or intermediate-high risk PE, 63(21.6%) patients had bleeding history. The mean treatment duration was 209.0 (SD 125.48) days. During treatment, major bleeding occurred in 4 patients (1.4%, 95% CI 0.4%-3.5%), and all the major bleeding events occurred within 90 days after initiation, no major bleeding event occurred from Day 91 to 360. No bleeding in a critical area or organ was observed. Two symptomatic recurrent venous thromboembolic events (VTE) occurred in 2 patients (0.7%, 95% CI 0.1%-2.5%) within the first 90 days, and no recurrent VTE was observed from Day 91 to 360.

Conclusion(s): Rivaroxaban exhibited a favorable long-term safety profile in relatively complicated acute PE patients under Chinese routine clinical practice. The incidence proportions of major bleeding and symptomatic recurrent VTE were consistent with the phase III clinical trial EINSTEIN and comparable to other real-world studies.