癌症相关孤立性远端深静脉血栓形成的临床结果：无症状和有症状血栓形成的比较——来自ONCO DVT研究的结果

IF 3.4 3区医学 Q2 HEMATOLOGY

Research and Practice in Thrombosis and Haemostasis Pub Date : 2025-02-01 DOI:10.1016/j.rpth.2025.102722

Yoshito Ogihara , Yugo Yamashita , Takeshi Morimoto , Nao Muraoka , Michihisa Umetsu , Yuji Nishimoto , Takuma Takada , 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 , Kaoru Dohi

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引用次数: 0

摘要

背景：孤立性远端深静脉血栓形成（IDDVT）患者复发静脉血栓栓塞（VTE）的风险通常较低，特别是当IDDVT无症状时。然而，患有IDDVT的癌症患者，即使是无症状的IDDVT，也可能有更高的静脉血栓栓塞复发风险。目的比较肿瘤合并无症状性和有症状性IDDVT的临床疗效。方法ONCO深静脉血栓试验是一项随机临床试验，比较了12个月和3个月的依多沙班治疗方案对IDDVT癌症患者的疗效。在这项事后分析中，601例患者根据诊断时iddvt相关症状分为无症状组（n = 479）和有症状组（n = 122）。主要结局是12个月时症状性静脉血栓栓塞复发或静脉血栓栓塞相关死亡，而主要次要结局是12个月时大出血。结果无症状组12个月累计主要转归发生率低于有症状组(2.9% vs 13.4%；P & lt;措施;风险比0.21；95% ci, 0.10-0.47)。无症状组12例有症状性复发性静脉血栓栓塞患者中，8例（67%）有IDDVT复发，11例（92%）停止抗凝治疗后复发。无症状组12个月累计大出血发生率低于有症状组(7.8%和13.2%；P = .048)。结论无症状性IDDVT患者复发有症状性静脉血栓栓塞的风险低于有症状性IDDVT患者。大多数复发性静脉血栓栓塞事件为复发性IDDVT，大多数发生在停止抗凝治疗后。

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Clinical outcomes of cancer-associated isolated distal deep vein thrombosis: a comparison between asymptomatic and symptomatic thrombosis—findings from the ONCO DVT Study

Background

The risk of recurrent venous thromboembolism (VTE) in patients with isolated distal deep vein thrombosis (IDDVT) is generally low, particularly when IDDVT is asymptomatic. However, cancer patients with IDDVT, even asymptomatic IDDVT, may be at a higher risk of recurrent VTE.

Objectives

To compare the clinical outcomes of cancer patients with asymptomatic and symptomatic IDDVT.

Methods

The ONCO DVT trial is a randomized clinical trial that compared 12-month versus 3-month edoxaban treatment regimens in cancer patients with IDDVT. In this post hoc analysis, 601 patients were categorized into the asymptomatic (n = 479) and symptomatic (n = 122) groups based on IDDVT-related symptoms at diagnosis. The primary outcome was the composite of symptomatic recurrent VTE or VTE-related death at 12 months, while the major secondary outcome was major bleeding at 12 months.

Results

The cumulative 12-month incidence of the primary outcome was lower in the asymptomatic group than that in the symptomatic group (2.9% vs 13.4%; P < .001; hazard ratio, 0.21; 95% CI, 0.10-0.47). Among the 12 patients with symptomatic recurrent VTE in the asymptomatic group, 8 (67%) had recurrent IDDVT, and 11 (92%) experienced recurrence after discontinuing anticoagulation therapy. The cumulative 12-month incidence of major bleeding was lower in the asymptomatic group than that in the symptomatic group (7.8% and 13.2%; P = .048).

Conclusion

The risk of recurrent symptomatic VTE was lower in cancer patients with asymptomatic IDDVT than in those with symptomatic IDDVT. Most recurrent VTE events were recurrent IDDVT, with the majority occurring after discontinuing anticoagulation therapy.

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