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<p>The ONCO DVT study demonstrated the benefit of extended anticoagulation therapy with edoxaban in patients with cancer-associated isolated distal deep vein thrombosis (DVT). However, it remains unclear whether these results can be applied regardless of the number of thrombosed venous segments. In this post-hoc subgroup analysis of the ONCO DVT study, 601 patients were stratified into the single-site (N=268) and multiple-sites (N=333) DVT subgroups based on the number of thrombosed venous segments at diagnosis. We compared 12-month and 3-month edoxaban treatment groups in each subgroup for the primary endpoint of symptomatic recurrent venous thromboembolism (VTE) or VTE-related death and the major secondary endpoint of major bleeding at 12 months. The cumulative 12-month incidence of the primary endpoint was significantly lower in the 12-month edoxaban group than in the 3-month edoxaban group both in the single-site (0.8% vs. 8.8%, log-rank P=0.007) and in the multiple-sites DVT subgroups (1.4% vs. 8.2%, log-rank P=0.008) without treatment-by-subgroup interaction (P for interaction=0.69). There was no significant difference in the cumulative 12-month incidence of the major secondary endpoint between the 12-month and 3-month edoxaban groups either in the single-site (10.1% vs. 5.0%, log-rank P=0.14) or in the multiple-sites DVT subgroups (10.3% vs. 10.0%, log-rank P=0.98) without treatment-by-subgroup interaction (P for interaction=0.25). In patients with cancer-associated isolated distal DVT, 12-month edoxaban treatment compared to 3-month edoxaban treatment significantly reduced thrombotic events without increasing bleeding risk, suggesting the potential benefit of extended anticoagulation therapy irrespective of the number of thrombosed venous segments at diagnosis.</p> Graphical Abstract <p></p>

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Number of thrombosed venous segments and clinical outcomes in cancer-associated isolated distal deep vein thrombosis: insights from the ONCO DVT Study

  • 期刊论文

  • 发表日期：

    2026年4月29日

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  • Kanna Nakamura,
  • Yugo Yamashita,
  • Takeshi Morimoto,
  • Nao Muraoka,
  • Michihisa Umetsu,
  • Yuji Nishimoto,
  • Takuma Takada,
  • Yoshito Ogihara,
  • Tatsuya Nishikawa,
  • Nobutaka Ikeda,
  • Kazunori Otsui,
  • Daisuke Sueta,
  • Yukari Tsubata,
  • Masaaki Shoji,
  • Ayumi Shikama,
  • Yutaka Hosoi,
  • Yasuhiro Tanabe,
  • Ryuki Chatani,
  • Kengo Tsukahara,
  • Naohiko Nakanishi,
  • Kitae Kim,
  • Satoshi Ikeda,
  • Koh Ono,
  • Takeshi Kimura

摘要

The ONCO DVT study demonstrated the benefit of extended anticoagulation therapy with edoxaban in patients with cancer-associated isolated distal deep vein thrombosis (DVT). However, it remains unclear whether these results can be applied regardless of the number of thrombosed venous segments. In this post-hoc subgroup analysis of the ONCO DVT study, 601 patients were stratified into the single-site (N=268) and multiple-sites (N=333) DVT subgroups based on the number of thrombosed venous segments at diagnosis. We compared 12-month and 3-month edoxaban treatment groups in each subgroup for the primary endpoint of symptomatic recurrent venous thromboembolism (VTE) or VTE-related death and the major secondary endpoint of major bleeding at 12 months. The cumulative 12-month incidence of the primary endpoint was significantly lower in the 12-month edoxaban group than in the 3-month edoxaban group both in the single-site (0.8% vs. 8.8%, log-rank P=0.007) and in the multiple-sites DVT subgroups (1.4% vs. 8.2%, log-rank P=0.008) without treatment-by-subgroup interaction (P for interaction=0.69). There was no significant difference in the cumulative 12-month incidence of the major secondary endpoint between the 12-month and 3-month edoxaban groups either in the single-site (10.1% vs. 5.0%, log-rank P=0.14) or in the multiple-sites DVT subgroups (10.3% vs. 10.0%, log-rank P=0.98) without treatment-by-subgroup interaction (P for interaction=0.25). In patients with cancer-associated isolated distal DVT, 12-month edoxaban treatment compared to 3-month edoxaban treatment significantly reduced thrombotic events without increasing bleeding risk, suggesting the potential benefit of extended anticoagulation therapy irrespective of the number of thrombosed venous segments at diagnosis.

Graphical Abstract