Key result
In Japanese routine clinical practice, rivaroxaban treatment for venous thromboembolism was associated with a major bleeding rate of 2.89% (3.60%/patient-year) and a symptomatic recurrent VTE rate of 1.09% (1.36%/patient-year).
Why the study?
Venous thromboembolism is increasing in Japan, but relatively few Japanese patients have been included in studies evaluating rivaroxaban for VTE treatment and secondary prevention.
Cohort (n=2,540)
Open-label
Yes
In Japanese real-world clinical practice, rivaroxaban demonstrated a favorable safety and effectiveness profile for the treatment of VTE and prevention of recurrence, including in elderly patients and those with low body weight or impaired renal function.
Supports real-world rivaroxaban use for VTE in Japanese patients; leaves open need for randomized confirmation before practice change.
BACKGROUND: The incidence of venous thromboembolism (VTE; pulmonary embolism [PE] and/or deep vein thrombosis [DVT]) in Japan is increasing, but relatively small numbers of patients from Japan have been included in studies investigating rivaroxaban (a direct factor Xa inhibitor) for the treatment of VTE and preventing its recurrence. METHODS AND RESULTS: An open-label, prospective, observational study (XASSENT [NCT02558465]) investigated the safety profile and effectiveness of rivaroxaban for ≤2 years in the treatment of VTE and prevention of its recurrence in Japanese clinical practice. Primary outcomes were major bleeding and symptomatic recurrent VTE. Statistical analyses were exploratory and descriptive. Overall, 2,540 patients were enrolled (safety analysis population [SAP], n=2,387; effectiveness analysis population [EAP], n=2,386). In the SAP, >80% of patients received the approved rivaroxaban dose, the mean (standard deviation) age was 66.6 (15.0) years, ≈74% were >50 kg, and 43% had a creatinine clearance ≥80 mL/min. PE+DVT, PE only, and DVT only were reported in 42%, 8%, and 50% of patients, respectively, and active cancer in 17% of patients. Major bleeding was reported in 69 patients (2.89%; 3.60%/patient-year; SAP) and symptomatic PE/DVT recurrence in 26 patients (1.09%; 1.36%/patient-year; EAP) during the treatment period. CONCLUSIONS: XASSENT provided information on the expected proportions of bleeding and VTE recurrence during rivaroxaban treatment in Japanese clinical practice; no new concerns of safety or effectiveness were found.
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Fukuda et al. (2023) conducted a cohort in Venous thromboembolism (VTE) (n=2,540). Rivaroxaban was evaluated on Major bleeding. In Japanese routine clinical practice, rivaroxaban treatment for venous thromboembolism was associated with a major bleeding rate of 2.89% (3.60%/patient-year) and a symptomatic recurrent VTE rate of 1.09% (1.36%/patient-year).
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