タカダ　タクマ   TAKADA Takuma   髙田　卓磨    所属   医学研究科 医学研究科 (医学部医学科をご参照ください)    職種   非常勤講師
論文種別	原著
言語種別	英語
査読の有無	査読あり
表題	Rivaroxaban for 18 Months Versus 6 Months in Patients With Cancer and Acute Low-Risk Pulmonary Embolism: An Open-Label, Multicenter, Randomized Clinical Trial (ONCO PE 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	pp.Online ahead of print
著者・共著者	Yamashita Yugo, Morimoto Takeshi, Muraoka Nao, Shioyama Wataru, Chatani Ryuki, Shibata Tatsuhiro, Nishimoto Yuji, Ogihara Yoshito, Doi Kosuke, Oi Maki, Shiga Taro, Sueta Daisuke, Kim Kitae, Tanabe Yasuhiro, Koitabashi Norimichi, Takada Takuma, Ikeda Satoshi, Nakagawa Hitoshi, Tsukahara Kengo, Shoji Masaaki, Sakamoto Jiro, Hisatake Shinji, Ogino Yutaka, Fujita Masashi, Nakanishi Naohiko, Dohke Tomohiro, Hiramori Seiichi, Nawada Ryuzo, Kaneda Kazuhisa, Ono Koh, Kimura Takeshi,
発行年月	2024/11
概要	BACKGROUND:The optimal duration of anticoagulation therapy for patients with cancer and acute low-risk pulmonary embolism (PE) is clinically relevant, but evidence is lacking. 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 32 institutions in Japan, we randomly assigned patients with cancer and acute low-risk PE of the simplified version of the Pulmonary Embolism Severity Index score of 1, in a 1:1 ratio, to receive either an 18-month or a 6-month rivaroxaban treatment. The primary end point was recurrent venous thromboembolism (VTE) at 18 months. The major secondary end point was major bleeding at 18 months according to the criteria of the International Society on Thrombosis and Hemostasis. The primary hypothesis was that an 18-month treatment was superior to a 6-month treatment in terms of the primary end point.RESULTS:From February 2021 to March 2023, 179 patients were randomized, and after the exclusion of one patient who withdrew consent, 178 were included in the intention-to-treat population: 89 patients in the 18-month rivaroxaban group and 89 in the 6-month rivaroxaban group. The mean age was 65.7 years; 47% of the patients were men, and 12% had symptoms of PE at baseline. The primary end point of recurrent VTE occurred in 5 of the 89 patients (5.6%) in the 18-month rivaroxaban group and in 17 of the 89 (19.1%) in the 6-month rivaroxaban group (odds ratio, 0.25 [95% CI, 0.09-0.72]; P=0.01). Among 22 recurrent VTE, 5 patients presented with a symptomatic recurrent VTE; recurrent PE occurred in 11 patients, including 2 with main and 4 with lobar PEs; and recurrent deep vein thrombosis was seen in 11 patients, including 3 with proximal deep vein thromboses. The major secondary end point of major bleeding occurred in 7 of the 89 patients (7.8 %) in the 18-month rivaroxab
DOI	10.1161/CIRCULATIONAHA.124.072758
PMID	39556015