D-dimer after 3 months of anticoagulation therapy and outcomes in cancer-associated isolated distal deep vein thrombosis

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%; <i>P</i> = .02; odds ratio [OR], 0.12; 95% confidence interval [CI], 0.01-0.66) and high D-dimer (0.9% vs 10.2%; <i>P</i> = .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%; <i>P</i> = .64; OR, 1.96; 95% CI, 0.47-9.67) and high D-dimer (18.3% vs 14.6%; <i>P</i> = .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.

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Journal
Blood Vessels Thrombosis & Hemostasis
Published
2025-02-24
DOI
https://doi.org/10.1016/j.bvth.2025.100063
Primary Topic
Venous Thromboembolism Diagnosis and Management
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article
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article

D-dimer after 3 months of anticoagulation therapy and outcomes in cancer-associated isolated distal deep vein thrombosis

Nao Muraoka, Koh Ono, Satoshi Ikeda, Kazunori Otsui et al.
Blood Vessels Thrombosis & Hemostasis
Venous Thromboembolism Diagnosis and Management
article

D-dimer after 3 months of anticoagulation therapy and outcomes in cancer-associated isolated distal deep vein thrombosis

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

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%; <i>P</i> = .02; odds ratio [OR], 0.12; 95% confidence interval [CI], 0.01-0.66) and high D-dimer (0.9% vs 10.2%; <i>P</i> = .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%; <i>P</i> = .64; OR, 1.96; 95% CI, 0.47-9.67) and high D-dimer (18.3% vs 14.6%; <i>P</i> = .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.

Blood Vessels Thrombosis & HemostasisVol. 2(2)
Toho University (JP), University of Tsukuba (JP), St. Marianna University School of Medicine (JP), Shimane University (JP), Mie University (JP), Kyorin University (JP), Kyoto University (JP), Fujisawa City Hospital (JP), Osaka Prefectural Medical Center (JP), Kyoto Prefectural University of Medicine (JP), Shizuoka Cancer Center (JP), Kurashiki Central Hospital (JP), Toho University Ohashi Medical Center (JP), Tohoku University Hospital (JP), Osaka City General Hospital (JP), Tokyo Women's Medical University (JP), Osaka International Cancer Institute (JP), Tokyo National Hospital (JP), Kobe City Medical Center General Hospital (JP), Akashi Medical Center (JP), Municipal Hirakata City Hospital (JP), Nagasaki University (JP), Kobe University (JP), Hyogo University (JP), Kumamoto University (JP)
Daiichi Sankyo Company
Good health and well-being
Openalex Percentile: Top 92%
Venous Thromboembolism Diagnosis and Management
DOIOpen Access PDFOpenAlex
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