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Long-term rivaroxaban for the treatment of acute venous thromboembolism in patients with active cancer in a prospective multicenter trial
- Title
- Long-term rivaroxaban for the treatment of acute venous thromboembolism in patients with active cancer in a prospective multicenter trial
- Authors
- Yhim, Ho-Young; Choi, Won-Il; Kim, Sung-Hyun; Nam, Seung-Hyun; Kim, Kyoung Ha; Mun, Yeung-Chul; Oh, Doyeun; Hwang, Hun-Gyu; Lee, Keun-Wook; Song, Eun-Kee; Kwon, Yong Shik; Bang, Soo-Mee
- Ewha Authors
- 문영철
- SCOPUS Author ID
- 문영철
- Issue Date
- 2019
- Journal Title
- KOREAN JOURNAL OF INTERNAL MEDICINE
- ISSN
- 1226-3303
2005-6648
- Citation
- KOREAN JOURNAL OF INTERNAL MEDICINE vol. 34, no. 5, pp. 1125 - 1135
- Keywords
- Neoplasms; Recurrence; Rivaroxaban; Venous thromboembolism; Therapeutics
- Publisher
- KOREAN ASSOC INTERNAL MEDICINE
- Indexed
- SCIE; SCOPUS; KCI
- Document Type
- Article
- Abstract
- 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 no (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.
- DOI
- 10.3904/kjim.2018.097
- Appears in Collections:
- 의과대학 > 의학과 > Journal papers
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