Prolonged Edoxaban in Patients With Low Body Weight and Cancer-Associated Isolated Distal Deep Vein Thrombosis

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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Main Authors: 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
Format: Article
Language:English
Published: Elsevier 2025-08-01
Series:JACC: Advances
Subjects:
cancer-associated thrombosis
edoxaban
isolated distal deep vein thrombosis
low body weight
venous thromboembolism
Online Access:http://www.sciencedirect.com/science/article/pii/S2772963X25003771
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Summary: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.
ISSN:2772-963X

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