{"title":"依多沙班在癌症和非癌症静脉血栓栓塞患者中的抗凝作用。","authors":"Masashi Yoshida, Kentaro Ejiri, Naoaki Matsuo, Takanori Naito, Kazuhiro Kuroda, Koji Tokioka, Kunihiko Hatanaka, Ryohei Fujimoto, Hidenaru Yamaoka, Yutaka Kajikawa, Kazuki Suruga, Hiroki Sugiyama, Tsuyoshi Miyaji, Yoshimasa Morimoto, Nobuhiro Okamura, Toshihiro Sarashina, Satoshi Akagi, Toru Miyoshi, Kazufumi Nakamura, Hiroshi Ito, Shinsuke Yuasa","doi":"10.1186/s12959-025-00720-0","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Edoxaban, a direct oral anticoagulant (DOAC), is a first-line treatment for venous thromboembolism (VTE) and the suppression of VTE recurrence. In patients with cancer, however, recurrent VTE after DOAC treatment may be more common than in noncancer patients. To evaluate our hypothesis that the anticoagulation effect of edoxaban is lower in VTE patients with cancer than in noncancer patients.</p><p><strong>Methods: </strong>This study was a prospective, multicenter, observational study including patients treated with edoxaban for VTE in Japan. The primary outcome was the difference in the prothrombin time (PT), activated partial thromboplastin time (APTT), and D-dimer level at 5 h after initial edoxaban administration between the cancer and noncancer groups. An additional outcome was the longitudinal change in PT and APTT from 5 h to overnight after edoxaban administration. The incidence of adverse events was further investigated.</p><p><strong>Results: </strong>PT and APTT at 5 h after initial edoxaban administration were not significantly different between the cancer (n = 84) and noncancer groups (n = 138) (e.g., log-transformed APTT 3.55 vs. 3.55, p = 0.45). However, D-dimer in the cancer groups was significantly greater than that in the noncancer groups (log-transformed 1.83 vs. 1.79, p = 0.009). PT and APTT significantly decreased from 5 h to overnight after edoxaban, but a similar pattern was observed in each group. All adverse events after edoxaban administration were also similar between patients with cancer and noncancer.</p><p><strong>Conclusion: </strong>PT and APTT after edoxaban administration were similar between VTE patients with cancer and noncancer groups, suggesting that edoxaban has anticoagulation effects on cancer-associated VTE similar to those of noncancer patients.</p><p><strong>Trial registration: </strong>UMIN000041973; Registration Date: 2020.10.5.</p>","PeriodicalId":22982,"journal":{"name":"Thrombosis Journal","volume":"23 1","pages":"36"},"PeriodicalIF":2.6000,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12001618/pdf/","citationCount":"0","resultStr":"{\"title\":\"Anticoagulant effects of edoxaban in cancer and noncancer patients with venous thromboembolism.\",\"authors\":\"Masashi Yoshida, Kentaro Ejiri, Naoaki Matsuo, Takanori Naito, Kazuhiro Kuroda, Koji Tokioka, Kunihiko Hatanaka, Ryohei Fujimoto, Hidenaru Yamaoka, Yutaka Kajikawa, Kazuki Suruga, Hiroki Sugiyama, Tsuyoshi Miyaji, Yoshimasa Morimoto, Nobuhiro Okamura, Toshihiro Sarashina, Satoshi Akagi, Toru Miyoshi, Kazufumi Nakamura, Hiroshi Ito, Shinsuke Yuasa\",\"doi\":\"10.1186/s12959-025-00720-0\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Edoxaban, a direct oral anticoagulant (DOAC), is a first-line treatment for venous thromboembolism (VTE) and the suppression of VTE recurrence. In patients with cancer, however, recurrent VTE after DOAC treatment may be more common than in noncancer patients. To evaluate our hypothesis that the anticoagulation effect of edoxaban is lower in VTE patients with cancer than in noncancer patients.</p><p><strong>Methods: </strong>This study was a prospective, multicenter, observational study including patients treated with edoxaban for VTE in Japan. The primary outcome was the difference in the prothrombin time (PT), activated partial thromboplastin time (APTT), and D-dimer level at 5 h after initial edoxaban administration between the cancer and noncancer groups. An additional outcome was the longitudinal change in PT and APTT from 5 h to overnight after edoxaban administration. The incidence of adverse events was further investigated.</p><p><strong>Results: </strong>PT and APTT at 5 h after initial edoxaban administration were not significantly different between the cancer (n = 84) and noncancer groups (n = 138) (e.g., log-transformed APTT 3.55 vs. 3.55, p = 0.45). However, D-dimer in the cancer groups was significantly greater than that in the noncancer groups (log-transformed 1.83 vs. 1.79, p = 0.009). PT and APTT significantly decreased from 5 h to overnight after edoxaban, but a similar pattern was observed in each group. All adverse events after edoxaban administration were also similar between patients with cancer and noncancer.</p><p><strong>Conclusion: </strong>PT and APTT after edoxaban administration were similar between VTE patients with cancer and noncancer groups, suggesting that edoxaban has anticoagulation effects on cancer-associated VTE similar to those of noncancer patients.</p><p><strong>Trial registration: </strong>UMIN000041973; Registration Date: 2020.10.5.</p>\",\"PeriodicalId\":22982,\"journal\":{\"name\":\"Thrombosis Journal\",\"volume\":\"23 1\",\"pages\":\"36\"},\"PeriodicalIF\":2.6000,\"publicationDate\":\"2025-04-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12001618/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Thrombosis Journal\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s12959-025-00720-0\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"HEMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Thrombosis Journal","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s12959-025-00720-0","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"HEMATOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
背景：依多沙班是一种直接口服抗凝剂（DOAC），是静脉血栓栓塞（VTE）和抑制VTE复发的一线治疗药物。然而，在癌症患者中，DOAC治疗后静脉血栓栓塞复发可能比非癌症患者更常见。为了评估我们的假设，即依多沙班的抗凝作用在静脉血栓栓塞癌症患者中低于非癌症患者。方法：本研究是一项前瞻性、多中心、观察性研究，包括在日本接受依多沙班治疗静脉血栓栓塞的患者。主要结果是癌症组和非癌症组在初始使用依多沙班后5小时凝血酶原时间（PT）、活化的部分凝血活酶时间（APTT）和d -二聚体水平的差异。另一个结果是给药后5小时至夜间PT和APTT的纵向变化。进一步调查不良事件的发生率。结果：肿瘤组（n = 84）和非肿瘤组（n = 138）初始给药后5 h的PT和APTT无显著差异（例如，log-transformed APTT 3.55 vs. 3.55, p = 0.45）。然而，癌症组的d -二聚体明显大于非癌症组（log-转化1.83 vs. 1.79, p = 0.009）。在使用依多沙班后5 h至夜间，PT和APTT均显著下降，但各组的模式相似。依多沙班给药后的所有不良事件在癌症和非癌症患者之间也相似。结论：依多沙班给药后的PT和APTT在癌症组和非癌症组VTE患者之间相似，提示依多沙班对癌症相关性VTE的抗凝作用与非癌症组相似。试验注册号：UMIN000041973；报名日期：2020.10.5。
Anticoagulant effects of edoxaban in cancer and noncancer patients with venous thromboembolism.
Background: Edoxaban, a direct oral anticoagulant (DOAC), is a first-line treatment for venous thromboembolism (VTE) and the suppression of VTE recurrence. In patients with cancer, however, recurrent VTE after DOAC treatment may be more common than in noncancer patients. To evaluate our hypothesis that the anticoagulation effect of edoxaban is lower in VTE patients with cancer than in noncancer patients.
Methods: This study was a prospective, multicenter, observational study including patients treated with edoxaban for VTE in Japan. The primary outcome was the difference in the prothrombin time (PT), activated partial thromboplastin time (APTT), and D-dimer level at 5 h after initial edoxaban administration between the cancer and noncancer groups. An additional outcome was the longitudinal change in PT and APTT from 5 h to overnight after edoxaban administration. The incidence of adverse events was further investigated.
Results: PT and APTT at 5 h after initial edoxaban administration were not significantly different between the cancer (n = 84) and noncancer groups (n = 138) (e.g., log-transformed APTT 3.55 vs. 3.55, p = 0.45). However, D-dimer in the cancer groups was significantly greater than that in the noncancer groups (log-transformed 1.83 vs. 1.79, p = 0.009). PT and APTT significantly decreased from 5 h to overnight after edoxaban, but a similar pattern was observed in each group. All adverse events after edoxaban administration were also similar between patients with cancer and noncancer.
Conclusion: PT and APTT after edoxaban administration were similar between VTE patients with cancer and noncancer groups, suggesting that edoxaban has anticoagulation effects on cancer-associated VTE similar to those of noncancer patients.
期刊介绍：
Thrombosis Journal is an open-access journal that publishes original articles on aspects of clinical and basic research, new methodology, case reports and reviews in the areas of thrombosis.
Topics of particular interest include the diagnosis of arterial and venous thrombosis, new antithrombotic treatments, new developments in the understanding, diagnosis and treatments of atherosclerotic vessel disease, relations between haemostasis and vascular disease, hypertension, diabetes, immunology and obesity.
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