Long-term rivaroxaban for the treatment of acute venous thromboembolism in patients with active cancer in a prospective multicenter trial

Ho Young Yhim, Won Il Choi, Sung Hyun Kim, Seung Hyun Nam, Kyoung Ha Kim, Yeung Chul Mun, Doyeun Oh, Hun Gyu Hwang, Keun Wook Lee, Eun Kee Song, Yong Shik Kwon, Soo Mee Bang

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11 Scopus citations


Background/Aims: Limited data are available regarding the efficacy of rivaroxaban for the treatment of cancer-associated venous thromboembolism (VTE). The aim of this study was to evaluate the effectiveness and safety of rivaroxaban for the treatment of VTE in active cancer patients. Methods: In this prospective, multicenter, open-label trial (NCT01989845), we enrolled patients with active cancer and objectively diagnosed lower-extremity deep vein thrombosis, pulmonary embolism (PE), or both from November 2013 to June 2016. Active cancer was defined as a histologically confirmed malignancy, which was diagnosed or treated within the previous 6 months, or as a recurrent/metastatic cancer. Patients received oral rivaroxaban 15 mg twice daily for first 3 weeks, followed by 20 mg once daily for 6 months. The primary outcome was the symptomatic recurrent VTE and the secondary outcomes included any recurrent VTE, major or clinically relevant non-major (CRNM) bleeding events, and overall mortality. All study outcomes were validated by blinded central adjudication. Results: Of 124 patients enrolled, 110 (88.7%) had solid cancer, 93 (75.0%) had metastatic disease, and 110 (88.7%) were receiving chemotherapy or radiotherapy. During the 6-month study period, seven patients experienced symptomatic recurrent VTE (cumulative incidence, 5.9%), and two patients experienced incidental recurrent PE (cumulative incidence of any recurrent VTE, 7.6%). Major bleeding events occurred in six patients (cumulative incidence, 5.3%) and CRNM bleeding events in 11 patients (cumulative incidence, 10.2%). Twenty-eight patients (overall mortality, 24.0%) died. Conclusions: Rivaroxaban is effective and safe for the treatment of VTE in patients with active cancer.

Original languageEnglish
Pages (from-to)1125-1135
Number of pages11
JournalKorean Journal of Internal Medicine
Issue number5
StatePublished - Sep 2019

Bibliographical note

Publisher Copyright:
© 2019 The Korean Association of Internal Medicine.


  • Neoplasms
  • Recurrence
  • Rivaroxaban
  • Therapeutics
  • Venous thromboembolism


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