Rivaroxaban treatment for asymptomatic venous thromboembolism: Insights from the J’xactly Study

Background: An established treatment strategy against asymptomatic pulmonary embolism (PE) or deep vein thrombosis (DVT) remains lacking in Japan; therefore, in this study, we clarify the characteristics and outcomes of symptomatic compared to asymptomatic patients with PE (n = 419) or DVT (n = 597). Methods: This prospective, multicenter sub-analysis of the J’xactly study in Japan included 1,016 patients (mean age, 68; 41% male) with venous thromboembolism (VTE) treated with rivaroxaban. Results: Asymptomatic PE patients (47% of PE patients) were more likely to have active cancer and asymptomatic proximal DVT at lower severity than symptomatic PE patients, despite no differences in age, sex, or the proportion receiving intensive 30 mg/day-rivaroxaban. Patients with asymptomatic DVT (34% of DVT patients) were older, had higher rates of female sex, active cancer, and distal DVT, and received shorter, less intense rivaroxaban treatment. Incidences did not differ between asymptomatic and symptomatic PE patients for recurrent symptomatic VTE (hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.22–1.62; P = 0.31) or major bleeding (HR, 0.68; 95% CI, 0.20–2.33; P = 0.58), nor between asymptomatic and symptomatic DVT patients for recurrent symptomatic VTE (HR, 0.56; 95% CI, 0.23–1.40; P = 0.21) and major bleeding (HR, 1.47; 95% CI, 0.54–3.97; P = 0.45). Conclusions: The real-world composite adverse event rate for treatment with rivaroxaban, as physician-adjusted for dose and duration, was similar between asymptomatic and symptomatic patients regardless of the presence of PE or DVT, suggesting a favorable safety profile for potential rivaroxaban treatment for asymptomatic VTE.