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
- Dept. of Internal Medicine (내과학)
- Issue Date
- Korean journal of internal medicine, Vol.34(5) : 1125-1135, 2019
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.
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.
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.
Rivaroxaban is effective and safe for the treatment of VTE in patients with active cancer.
- Neoplasms; Recurrence; Rivaroxaban; Venous thromboembolism; Therapeutics
- Appears in Collections:
- 1. Journal Papers (연구논문) > 1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
- Keimyung Author(s)
- 최원일; 권용식
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