Utility of Rivaroxaban for Real-World Patients With Venous Thromboembolism

highly selected patients, who might not representative of real-world practice. Because the clinical outcomes of rivaroxaban in the real world might not necessarily coincide with the clinical outcomes in RCTs, the effectiveness and safety of rivaroxaban in unselected real-world patients be important. Furthermore, it is also clinically relevant whether this is the case in the Japanese pop-In this issue of the Journal, Fukuda et al 5 report the clinical outcomes of rivaroxaban in the real-world patients in Japan using the open-label, prospective observational study, XASSENT (NCT02558465). A previous multicenter, prospective observational study, J'xactly, which A nticoagulation therapy is essential for the treatment and second prevention of venous thromboembolism (VTE), including pulmonary embolism (PE) and deep vein thrombosis (DVT). Vitamin K antagonists (VKA), including warfarin, were the only available oral anticoagulant in the past, but several direct oral anticoagulants (DOAC), such as rivaroxaban, have been introduced as novel treatments for VTE. The EINSTEIN PE/ DVT trial, a large-scale multinational randomized clinical trial (RCT), demonstrated similar efficacy and safety of rivaroxaban, compared with conventional treatment using VKA, 1,2 which was also confirmed in a Japanese population in the J-EINSTEIN PE/DVT trial. 3 Based on the RCT results and ease of use, rivaroxaban has prevailed in daily clinical practice in Japan. 4 However, RCTs are conducted under idealized and rigorously controlled conditions, with