TAKADA Takuma    Department   Research Institutes and Facilities, Research Institutes and Facilities    Position   Assistant Professor
Language	English
Title	Off-Label Under- and Overdosing of Direct Oral Anticoagulants in Patients with Venous Thromboembolism: From the COMMAND VTE Registry-2
Conference	第87回日本循環器学会学術集会
Conference Type	Nationwide Conferences
Presentation Type	Speech
Lecture Type	General
Publisher and common publisher	Shuhei Tsuji, Ryuki Chatani, Kazuhisa Kaneda, Yuji Nishimoto, Nobutaka Ikeda, Yohei Kobayashi, Satoshi Ikeda, Kite Kim, Toru Takase, Maki Ohi, Takuma Takada, Kazunori Otsui, Jiro Sakamoto, Yoshito Ogihara, Yugo Yamashita, Junichi Tazaki, Hiroki Watanabe, Mamoru Toyofuku
Date	2023/03/11
Venue (city and name of the country)	福岡
Summary	Background: Direct oral anticoagulants (DOACs) are currently widely used for the treatment of venous thromboembolism (VTE). Sometimes, off-label dosing of DOACs is prescribed. However, the true prevalence and its efficacy and safety remain unknown. Methods: The COMMAND VTE Registry-2 is a multicenter registry enrolling 5197 consecutive acute symptomatic VTE patients among 31 centers in Japan between January 2015 and August 2020. In this cohort, we examined the prevalence, and outcomes (all-cause death, major bleeding events, and VTE recurrences) associated with off-label DOAC dosing during VTE treatment. Results: The current study population consisted of 3,960 patients with maintenance treatments of DOACs, who were divided into 3 groups; appropriate dose (N=3,377, 85%), over-dose (N=167, 4%), and under-dose (N=416, 11%) groups. The cumulative incidence rates of major bleeding and VTE recurrences at 1-year were not significantly different among the groups (major bleeding: 5.9% vs. 5.9% vs. 6.6%, p=0.843 respectively; VTE recurrences: 2.6% vs. 4.7% vs. 3.0%, p=0.221 respectively). Whereas, the cumulative incidence rates of all-cause death at 1-year were significantly different among the groups (14.5% vs. 14.2% vs. 20.9%, p=0.004 respectively). At 5-year, the cumulative incidence rates of major bleeding and VTE recurrences were not significantly different among the groups (major bleeding: 12.9% vs. 12.9% vs. 14.9%, p=0.541 respectively; VTE recurrences: 9.8% vs. 12.8% vs. 4.8%, p=0.054 respectively). Whereas, the cumulative incidence rates of all-cause death at 5-year were significantly different among the groups (28.2% vs. 35.0% vs. 41.8%, p<0.001 respectively). Conclusion: In this population, there were no significant differences in major bleeding and VTE recurrences between appropriate and off-label doses of DOACs.