ミナミ　ユウイチロウ   MINAMI Yuuichirou   南　雄一郎    所属   医学部 医学科（東京女子医科大学病院）    職種   准教授
論文種別	原著
言語種別	英語
査読の有無	査読あり
表題	Edoxaban for 12 Months Versus 3 Months in Patients With Cancer Isolated Distal Deep Vein Thrombosis (ONCO DVT study): An Open-label, Multicenter, Randomized Clinical Trial.
掲載誌名	正式名：Circulation 略　 称：Circulation ISSNコード：15244539/00097322
掲載区分	国外
巻・号・頁	148(21),pp.1665-1676
著者・共著者	Yamashita Yugo, Morimoto Takeshi, Muraoka Nao, Oyakawa Takuya, Umetsu Michihisa, Akamatsu Daijirou, Nishimoto Yuji, Sato Yukihito, Takada Takuma, Jujo Kentaro, Minami Yuichiro, Ogihara Yoshito, Dohi Kaoru, Fujita Masashi, Nishikawa Tatsuya, Ikeda Nobutaka, Hashimoto Go, Otsui Kazunori, Mori Kenta, Sueta Daisuke, Tsubata Yukari, Shoji Masaaki, Shikama Ayumi, Hosoi Yutaka, Tanabe Yasuhiro, Chatani Ryuki, Tsukahara Kengo, Nakanishi Naohiko, Kim Kitae, Ikeda Satoshi, Mo Makoto, Yoshikawa Yusuke, Kimura Takeshi
発行年月	2023/08
概要	Background: The optimal duration of anticoagulation therapy for isolated distal deep vein thrombosis (DVT) in patients with cancer is clinically relevant, but the evidence is lacking. The prolonged anticoagulation therapy could have a potential benefit for prevention of thrombotic events, however, it could also increase the risk of bleeding. Methods: In a multicenter, open-label, adjudicator-blinded, randomized clinical trial at 60 institutions in Japan, we randomly assigned cancer patients with isolated distal DVT, in a 1-to-1 ratio, to receive either a 12-month or 3-month edoxaban treatment. The primary endpoint was a composite of a symptomatic recurrent venous thromboembolism (VTE) or VTE-related death at 12 months. The major secondary endpoint was major bleeding at 12 months, according to the criteria of the International Society on Thrombosis and Hemostasis. The primary hypothesis was that a 12-month edoxaban treatment was superior to a 3-month edoxaban treatment with respect to the primary endpoint. Results: From April 2019 through June 2022, 604 patients were randomized, and after excluding 3 patients who withdrew consent, 601 patients were included in the intention-to-treat population: 296 patients in the 12-month edoxaban group and 305 patients in the 3-month edoxaban group. The mean age was 70.8 years, 28% of the patients were men, and 20% of the patients had symptoms of DVT at baseline. The primary endpoint of a symptomatic recurrent VTE event or VTE-related death occurred in 3 of the 296 patients (1.0%) in the 12-month edoxaban group and in 22 of the 305 (7.2%) in the 3-month edoxaban group (odds ratio, 0.13; 95% CI, 0.03 to 0.44). The major secondary endpoint of major bleeding occurred in 28 of the 296 patients (9.5%) in the 12-month edoxaban group and in 22 of the 305 (7.2%) in the 3-month edoxaban group (odds ratio, 1.34; 95% CI, 0.75 to 2.41). The prespecified subgroups did not affect the estimates on the primary endpoint. Conclusions: In cancer pati
DOI	10.1161/CIRCULATIONAHA.123.066360
PMID	37638968