{"title":"D-dimer after 3 months of anticoagulation therapy and outcomes in cancer-associated isolated distal deep vein thrombosis","authors":"Tatsuya Nishikawa , Yugo Yamashita , Masashi Fujita , Takeshi Morimoto , Nao Muraoka , Michihisa Umetsu , Yuji Nishimoto , Takuma Takada , Yoshito Ogihara , Nobutaka Ikeda , Kazunori Otsui , Daisuke Sueta , Yukari Tsubata , Masaaki Shoji , Ayumi Shikama , Yutaka Hosoi , Yasuhiro Tanabe , Ryuki Chatani , Kengo Tsukahara , Naohiko Nakanishi , Takeshi Kimura","doi":"10.1016/j.bvth.2025.100063","DOIUrl":null,"url":null,"abstract":"<div><h3>Abstract</h3><div>Cancer-associated isolated distal deep vein thrombosis (IDDVT) is a common complication in patients with cancer. The Optimal Duration of Anticoagulation Therapy for Isolated Distal Deep Vein Thrombosis in Patients with Cancer study revealed the superiority of 12- over 3-month edoxaban treatment with respect to thrombotic risk. However, it remains unclear whether D-dimer levels during anticoagulation influence the efficacy of extended anticoagulation. In this post hoc subgroup analysis, we stratified 519 patients into the low D-dimer (<1.0 μg/mL) (n = 308) and high D-dimer (≥1.0 μg/mL) (n = 211) subgroups based on D-dimer levels at 3 months. The cumulative incidence of a composite of symptomatic recurrent venous thromboembolism (VTE) or VTE-related death was lower in the 12-month edoxaban group than in the 3-month edoxaban group in both the low D-dimer (0.8% vs 5.6%; <em>P</em> = .02; odds ratio [OR], 0.12; 95% confidence interval [CI], 0.01-0.66) and high D-dimer (0.9% vs 10.2%; <em>P</em> = .01; OR, 0.11; 95% CI, 0.01-0.62) subgroups without interaction. Furthermore, there was no significant difference in the cumulative incidence of major bleeding between the 12- and 3-month groups in both the low D-dimer (3.6% vs 1.8%; <em>P</em> = .64; OR, 1.96; 95% CI, 0.47-9.67) and high D-dimer (18.3% vs 14.6%; <em>P</em> = .29; OR, 1.27; 95% CI, 0.60-2.75) subgroups without interaction. In conclusion, a 12-month edoxaban treatment for cancer-associated IDDVT was superior to a 3-month treatment in reducing thrombotic events, irrespective of D-dimer levels after 3 months of anticoagulation therapy. There was no significant increased risk of major bleeding in the 12-month edoxaban group relative to the 3-month edoxaban group regardless of the D-dimer levels at 3 months. This trial was registered at <span><span>www.clinicaltrials.gov</span><svg><path></path></svg></span> as #NCT03895502.</div></div>","PeriodicalId":100190,"journal":{"name":"Blood Vessels, Thrombosis & Hemostasis","volume":"2 2","pages":"Article 100063"},"PeriodicalIF":0.0000,"publicationDate":"2025-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Blood Vessels, Thrombosis & Hemostasis","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2950327225000208","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
Cancer-associated isolated distal deep vein thrombosis (IDDVT) is a common complication in patients with cancer. The Optimal Duration of Anticoagulation Therapy for Isolated Distal Deep Vein Thrombosis in Patients with Cancer study revealed the superiority of 12- over 3-month edoxaban treatment with respect to thrombotic risk. However, it remains unclear whether D-dimer levels during anticoagulation influence the efficacy of extended anticoagulation. In this post hoc subgroup analysis, we stratified 519 patients into the low D-dimer (<1.0 μg/mL) (n = 308) and high D-dimer (≥1.0 μg/mL) (n = 211) subgroups based on D-dimer levels at 3 months. The cumulative incidence of a composite of symptomatic recurrent venous thromboembolism (VTE) or VTE-related death was lower in the 12-month edoxaban group than in the 3-month edoxaban group in both the low D-dimer (0.8% vs 5.6%; P = .02; odds ratio [OR], 0.12; 95% confidence interval [CI], 0.01-0.66) and high D-dimer (0.9% vs 10.2%; P = .01; OR, 0.11; 95% CI, 0.01-0.62) subgroups without interaction. Furthermore, there was no significant difference in the cumulative incidence of major bleeding between the 12- and 3-month groups in both the low D-dimer (3.6% vs 1.8%; P = .64; OR, 1.96; 95% CI, 0.47-9.67) and high D-dimer (18.3% vs 14.6%; P = .29; OR, 1.27; 95% CI, 0.60-2.75) subgroups without interaction. In conclusion, a 12-month edoxaban treatment for cancer-associated IDDVT was superior to a 3-month treatment in reducing thrombotic events, irrespective of D-dimer levels after 3 months of anticoagulation therapy. There was no significant increased risk of major bleeding in the 12-month edoxaban group relative to the 3-month edoxaban group regardless of the D-dimer levels at 3 months. This trial was registered at www.clinicaltrials.gov as #NCT03895502.