Tittl Luise, Köhler Christina, Marten Sandra, Naue Christiane, Beyer-Westendorf Jan
Division Hematology, Department of Medicine I, Thrombosis Research Unit, University Hospital "Carl Gustav Carus" Dresden, Dresden, Germany.
TH Open. 2025 Jul 5;9:a26354840. doi: 10.1055/a-2635-4840. eCollection 2025.
Direct oral anticoagulants such as edoxaban are standard of care in current treatment of venous thromboembolism (VTE). However, phase III trial data need confirmation in real-world settings. We extracted data from the prospective, noninterventional multiple-indication DRESDEN NOAC REGISTRY to evaluate outcome rates during VTE treatment with edoxaban. Patients were included in this analysis, if they had acute VTE and if patient enrolment and edoxaban initiation occurred within 30 days after VTE diagnosis. Patient characteristics, treatment persistence, and clinical outcomes were centrally adjudicated using standard definitions. Until December 31, 2023, 323 acute VTE patients (median age 67 years, 56.7% male) were enrolled and initiated edoxaban within 7.8 ± 4.9 days (mean) for isolated deep vein thrombosis (DVT) (57.6%) or pulmonary embolism (PE) ± DVT (42.4%). Mean duration of follow-up was 3.9 ± 1.9 years with a mean duration of edoxaban exposure of 1.5 ± 1.7 years. During ongoing edoxaban therapy, 3/323 patients (0.9%) experienced recurrent VTE (0.6/100 patient-years); 141/323 (43.7%) patients reported clinically relevant International Society on Thrombosis and Haemostasis (ISTH) nonmajor bleeding and 16 reported ISTH major bleeding (5.0%; 3.2/100 patient-years). Death was observed in 53 patients (4.1/100 patient-years). At 6 months, 78.2% were still taking edoxaban, 2% were electively switched to dose-reduced secondary prophylaxis with apixaban 2.5 mg twice a day or rivaroxaban 10 mg once daily. The remaining patients had a scheduled end of VTE treatment (11.4%) or were switched to nonedoxaban therapeutic anticoagulation (6.2%). Our results indicate effectiveness of edoxaban in acute VTE treatment with excellent persistence in the treatment and low rates of unplanned discontinuation. Bleeding was frequently observed, but rates of major bleeding were low and comparable to phase III data.
依度沙班等直接口服抗凝剂是目前治疗静脉血栓栓塞症（VTE）的标准治疗方法。然而，III期试验数据需要在真实世界环境中得到证实。我们从前瞻性、非干预性多适应症德累斯顿新型口服抗凝剂注册研究中提取数据，以评估依度沙班治疗VTE期间的结局发生率。如果患者患有急性VTE，且在VTE诊断后30天内纳入研究并开始使用依度沙班，则纳入本分析。使用标准定义对患者特征、治疗持续性和临床结局进行集中判定。截至2023年12月31日，323例急性VTE患者（中位年龄67岁，56.7%为男性）被纳入研究，并在7.8±4.9天（平均）内开始使用依度沙班，其中孤立性深静脉血栓形成（DVT）患者占57.6%，肺栓塞（PE）±DVT患者占42.4%。平均随访时间为3.9±1.9年，依度沙班暴露的平均时间为1.5±1.7年。在依度沙班持续治疗期间，3/323例患者（0.9%）发生复发性VTE（0.6/100患者年）；141/323例患者（43.7%）报告了具有临床意义的国际血栓与止血学会（ISTH）非大出血事件，16例报告了ISTH大出血事件（5.0%；3.2/100患者年）。53例患者死亡（4.1/100患者年）。在6个月时，78.2%的患者仍在服用依度沙班，2%的患者被选择性地换用剂量减半的阿哌沙班2.5mg每日两次或利伐沙班10mg每日一次进行二级预防。其余患者按计划结束VTE治疗（11.4%）或换用非依度沙班的治疗性抗凝药物（6.2%）。我们的结果表明依度沙班在急性VTE治疗中有效，治疗依从性良好，计划外停药率低。出血事件较为常见，但大出血发生率较低，与III期数据相当。
