Prolonged Edoxaban in Patients With Low Body Weight and Cancer-Associated Isolated Distal Deep Vein Thrombosis
Background: The ONCO DVT study revealed that 12-month edoxaban treatment for cancer-associated isolated distal deep vein thrombosis (IDDVT) was superior to 3-month edoxaban treatment. However, the influence of body weight on efficacy and safety remains unknown. Objectives: We compared 12-month and 3...
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2025-08-01
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| Series: | JACC: Advances |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2772963X25003771 |
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| author | Tomoyuki Nagai, MD Naohiko Nakanishi, MD Yugo Yamashita, MD Takeshi Morimoto, MPH, MD Nao Muraoka, MD Michihisa Umetsu, MD Yuji Nishimoto, MD Takuma Takada, MD Yoshito Ogihara, MD Tatsuya Nishikawa, MD Nobutaka Ikeda, MD Kazunori Otsui, MD Daisuke Sueta, MD Yukari Tsubata, MD Masaaki Shoji, MD Ayumi Shikama, MD Yutaka Hosoi, MD Yasuhiro Tanabe, MD Ryuki Chatani, MD Kengo Tsukahara, MD Kitae Kim, MD Satoshi Ikeda, MD Takeshi Kimura, MD Satoaki Matoba, MD |
| author_facet | Tomoyuki Nagai, MD Naohiko Nakanishi, MD Yugo Yamashita, MD Takeshi Morimoto, MPH, MD Nao Muraoka, MD Michihisa Umetsu, MD Yuji Nishimoto, MD Takuma Takada, MD Yoshito Ogihara, MD Tatsuya Nishikawa, MD Nobutaka Ikeda, MD Kazunori Otsui, MD Daisuke Sueta, MD Yukari Tsubata, MD Masaaki Shoji, MD Ayumi Shikama, MD Yutaka Hosoi, MD Yasuhiro Tanabe, MD Ryuki Chatani, MD Kengo Tsukahara, MD Kitae Kim, MD Satoshi Ikeda, MD Takeshi Kimura, MD Satoaki Matoba, MD |
| author_sort | Tomoyuki Nagai, MD |
| collection | DOAJ |
| description | Background: The ONCO DVT study revealed that 12-month edoxaban treatment for cancer-associated isolated distal deep vein thrombosis (IDDVT) was superior to 3-month edoxaban treatment. However, the influence of body weight on efficacy and safety remains unknown. Objectives: We compared 12-month and 3-month edoxaban treatments in patients with low body weight and cancer-associated IDDVT. Methods: In this prespecified subgroup analysis of the ONCO DVT study, we divided patients by body weight with a 60 kg cutoff. The primary endpoint was symptomatic recurrent venous thromboembolism or venous thromboembolism-related death at 12 months. Results: Of the 601 participants, 426 had low body weight, 99% receiving a reduced dose of edoxaban. The 1-year primary endpoint rate was significantly lower in the 12-month edoxaban group than in the 3-month group in both the low body weight (1.0% vs 6.2%, P = 0.003; OR: 0.15; 95% CI: 0.02-0.55) and the non-low body weight (1.0% vs 10.0%, P = 0.005; OR: 0.10; 95% CI: 0.01-0.54) subgroups. The 1-year major bleeding rate was not different between the 12-month and 3-month groups in the low body weight subgroup (7.0% vs 8.4%, P = 0.57), whereas in the non-low body weight subgroup, it was significantly higher in the 12-month edoxaban group than in the 3-month edoxaban group (14.7% vs 3.8%, P = 0.01). Conclusions: Twelve-month edoxaban treatment in cancer-associated IDDVT was superior to 3-month edoxaban treatment in terms of thrombotic events without increased bleeding risk among patients with low body weight but with increased bleeding risk among patients with non-low body weight. |
| format | Article |
| id | doaj-art-b11c4af26d564271ba6ca8386331a92b |
| institution | Kabale University |
| issn | 2772-963X |
| language | English |
| publishDate | 2025-08-01 |
| publisher | Elsevier |
| record_format | Article |
| series | JACC: Advances |
| spelling | doaj-art-b11c4af26d564271ba6ca8386331a92b2025-08-20T03:31:31ZengElsevierJACC: Advances2772-963X2025-08-014810195610.1016/j.jacadv.2025.101956Prolonged Edoxaban in Patients With Low Body Weight and Cancer-Associated Isolated Distal Deep Vein ThrombosisTomoyuki Nagai, MD0Naohiko Nakanishi, MD1Yugo Yamashita, MD2Takeshi Morimoto, MPH, MD3Nao Muraoka, MD4Michihisa Umetsu, MD5Yuji Nishimoto, MD6Takuma Takada, MD7Yoshito Ogihara, MD8Tatsuya Nishikawa, MD9Nobutaka Ikeda, MD10Kazunori Otsui, MD11Daisuke Sueta, MD12Yukari Tsubata, MD13Masaaki Shoji, MD14Ayumi Shikama, MD15Yutaka Hosoi, MD16Yasuhiro Tanabe, MD17Ryuki Chatani, MD18Kengo Tsukahara, MD19Kitae Kim, MD20Satoshi Ikeda, MD21Takeshi Kimura, MD22Satoaki Matoba, MD23Department of Cardiovascular Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kamigyo-ku, Kyoto, JapanDepartment of Cardiovascular Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kamigyo-ku, Kyoto, Japan; Address for correspondence: Dr Naohiko Nakanishi, Department of Cardiovascular Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kamigyo-ku, Kyoto 602-8566, Japan.Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Sakyo-ku, Kyoto, JapanDepartment of Clinical Epidemiology, Hyogo Medical University, Nishinomiya, JapanDivision of Cardiology, Shizuoka Cancer Center, Nagaizumi-cho, Sunto-gun, Shizuoka, JapanDivision of Vascular Surgery, Department of Surgery, Tohoku University Hospital, Aoba-ku, Sendai, JapanDivision of Cardiology, Osaka General Medical Center, Sumiyoshi-ku, Osaka, JapanDepartment of Cardiology, Tokyo Women's Medical University, Shinjuku-ku, Tokyo, JapanDepartment of Cardiology and Nephrology, Mie University Graduate School of Medicine, Tsu, JapanDepartment of Onco-Cardiology, Osaka International Cancer Institute, Chuo-ku, Osaka-shi, Osaka, JapanDivision of Cardiovascular Medicine, Toho University Ohashi Medical Center, Meguro-ku, Tokyo, JapanDepartment of General Internal Medicine, Kobe University Graduate School of Medicine, Chuo-ku, Kobe, JapanDepartment of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, JapanDepartment of Internal Medicine, Division of Medical Oncology and Respiratory Medicine, Shimane University Faculty of Medicine, Izumo, JapanDepartment of Cardiovascular Medicine, National Cancer Center Hospital, Chuo-ku, Tokyo, JapanDepartment of Obstetrics and Gynecology, Faculty of Medicine, University of Tsukuba, Tsukuba, JapanDepartment of Cardiovascular Surgery, Kyorin University Faculty of Medicine, Mitaka-shi, Tokyo, JapanDepartment of Cardiology, St. Marianna University School of Medicine, Miyamae-ku, Kawasaki, JapanDepartment of Cardiovascular Medicine, Kurashiki Central Hospital, Kurashiki, JapanDivision of Cardiology, Fujisawa City Hospital, Fujisawa, JapanDepartment of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Chuo-ku, Kobe, JapanDepartment of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, JapanDepartment of Cardiology, Hirakata Kohsai Hospital, Hirakata, JapanDepartment of Cardiovascular Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kamigyo-ku, Kyoto, JapanBackground: The ONCO DVT study revealed that 12-month edoxaban treatment for cancer-associated isolated distal deep vein thrombosis (IDDVT) was superior to 3-month edoxaban treatment. However, the influence of body weight on efficacy and safety remains unknown. Objectives: We compared 12-month and 3-month edoxaban treatments in patients with low body weight and cancer-associated IDDVT. Methods: In this prespecified subgroup analysis of the ONCO DVT study, we divided patients by body weight with a 60 kg cutoff. The primary endpoint was symptomatic recurrent venous thromboembolism or venous thromboembolism-related death at 12 months. Results: Of the 601 participants, 426 had low body weight, 99% receiving a reduced dose of edoxaban. The 1-year primary endpoint rate was significantly lower in the 12-month edoxaban group than in the 3-month group in both the low body weight (1.0% vs 6.2%, P = 0.003; OR: 0.15; 95% CI: 0.02-0.55) and the non-low body weight (1.0% vs 10.0%, P = 0.005; OR: 0.10; 95% CI: 0.01-0.54) subgroups. The 1-year major bleeding rate was not different between the 12-month and 3-month groups in the low body weight subgroup (7.0% vs 8.4%, P = 0.57), whereas in the non-low body weight subgroup, it was significantly higher in the 12-month edoxaban group than in the 3-month edoxaban group (14.7% vs 3.8%, P = 0.01). Conclusions: Twelve-month edoxaban treatment in cancer-associated IDDVT was superior to 3-month edoxaban treatment in terms of thrombotic events without increased bleeding risk among patients with low body weight but with increased bleeding risk among patients with non-low body weight.http://www.sciencedirect.com/science/article/pii/S2772963X25003771cancer-associated thrombosisedoxabanisolated distal deep vein thrombosislow body weightvenous thromboembolism |
| spellingShingle | Tomoyuki Nagai, MD Naohiko Nakanishi, MD Yugo Yamashita, MD Takeshi Morimoto, MPH, MD Nao Muraoka, MD Michihisa Umetsu, MD Yuji Nishimoto, MD Takuma Takada, MD Yoshito Ogihara, MD Tatsuya Nishikawa, MD Nobutaka Ikeda, MD Kazunori Otsui, MD Daisuke Sueta, MD Yukari Tsubata, MD Masaaki Shoji, MD Ayumi Shikama, MD Yutaka Hosoi, MD Yasuhiro Tanabe, MD Ryuki Chatani, MD Kengo Tsukahara, MD Kitae Kim, MD Satoshi Ikeda, MD Takeshi Kimura, MD Satoaki Matoba, MD Prolonged Edoxaban in Patients With Low Body Weight and Cancer-Associated Isolated Distal Deep Vein Thrombosis JACC: Advances cancer-associated thrombosis edoxaban isolated distal deep vein thrombosis low body weight venous thromboembolism |
| title | Prolonged Edoxaban in Patients With Low Body Weight and Cancer-Associated Isolated Distal Deep Vein Thrombosis |
| title_full | Prolonged Edoxaban in Patients With Low Body Weight and Cancer-Associated Isolated Distal Deep Vein Thrombosis |
| title_fullStr | Prolonged Edoxaban in Patients With Low Body Weight and Cancer-Associated Isolated Distal Deep Vein Thrombosis |
| title_full_unstemmed | Prolonged Edoxaban in Patients With Low Body Weight and Cancer-Associated Isolated Distal Deep Vein Thrombosis |
| title_short | Prolonged Edoxaban in Patients With Low Body Weight and Cancer-Associated Isolated Distal Deep Vein Thrombosis |
| title_sort | prolonged edoxaban in patients with low body weight and cancer associated isolated distal deep vein thrombosis |
| topic | cancer-associated thrombosis edoxaban isolated distal deep vein thrombosis low body weight venous thromboembolism |
| url | http://www.sciencedirect.com/science/article/pii/S2772963X25003771 |
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