Abstract：
BACKGROUND: Direct oral anticoagulants (DOACs) are recommended as the first-choice anticoagulation therapy in the acute phase of venous thromboembolism (VTE). However, there is limited real-world data for Japanese VTE patients.Methods and Results: The KUROSIO study (UMIN000023747) was a prospective long-term observational study comprising 1,017 patients with concurrent acute symptomatic pulmonary thromboembolism and proximal deep vein thrombosis (DVT) or isolated calf DVT initially treated with DOACs. After excluding 24 patients, 993 (mean age, 66.3±15.1 years; 58.6% females) were analyzed. The incidences of recurrent symptomatic VTE and major bleeding for up to 52 weeks after diagnosis were 3.2% and 2.2%, respectively. Multivariate analyses revealed chemotherapy and anemia as significant risk factors associated with recurrent symptomatic VTE and major bleeding, respectively.
CONCLUSIONS: The efficacy and safety of DOACs in Japanese patients with VTE were determined in this real-world observational study.
CONCLUSIONS: The efficacy and safety of DOACs in Japanese patients with VTE were determined in this real-world observational study.
摘要：
背景：推荐直接口服抗凝剂（DOAC）作为静脉血栓栓塞（VTE）急性期的首选抗凝治疗。然而,日本VTE患者的真实数据有限.方法和结果：KUROSIO研究（UMIN000023747）是一项前瞻性长期观察性研究，包括1,017例并发急性症状性肺血栓栓塞症和近端深静脉血栓形成（DVT）或最初接受DOAC治疗的孤立性小腿DVT患者。排除24名患者后，993(平均年龄，66.3±15.1岁；58.6％的女性）进行了分析。诊断后52周内症状性VTE复发和大出血的发生率分别为3.2%和2.2%，分别。多因素分析显示化疗和贫血是与复发性症状性静脉血栓栓塞和大出血相关的重要危险因素。分别。
结论：在这项真实世界的观察性研究中确定了DOAC在日本VTE患者中的疗效和安全性。
结论：在这项真实世界的观察性研究中确定了DOAC在日本VTE患者中的疗效和安全性。
