{"title":"Edoxaban treatment without initial heparin lead-in for acute venous thromboembolism: insight from the COMMAND VTE registry-2.","authors":"Yuta Tsujisaka, Yugo Yamashita, Takeshi Morimoto, Ryuki Chatani, Kazuhisa Kaneda, Yuji Nishimoto, Nobutaka Ikeda, Yohei Kobayashi, Satoshi Ikeda, Kitae Kim, Moriaki Inoko, Toru Takase, Shuhei Tsuji, Maki Oi, Takuma Takada, Kazunori Otsui, Jiro Sakamoto, Yoshito Ogihara, Takeshi Inoue, Shunsuke Usami, Po-Min Chen, Kiyonori Togi, Norimichi Koitabashi, Seiichi Hiramori, Kosuke Doi, Hiroshi Mabuchi, Yoshiaki Tsuyuki, Koichiro Murata, Kensuke Takabayashi, Hisato Nakai, Daisuke Sueta, Wataru Shioyama, Tomohiro Dohke, Ryusuke Nishikawa, Koh Ono, Takeshi Kimura","doi":"10.1007/s11239-025-03105-2","DOIUrl":null,"url":null,"abstract":"<p><p>The package insert of edoxaban for acute venous thromboembolism (VTE) recommended administration following initial parenteral anticoagulation including heparin. We explored the effectiveness and safety of edoxaban for acute VTE without initial heparin lead-in treatment. The COMMAND VTE Registry-2 is a multicenter registry enrolling 5197 consecutive acute symptomatic VTE patients in Japan between January 2015 and August 2020. The current study population consisted of 1842 patients with acute VTE treated with edoxaban. The baseline characteristics and clinical outcomes were compared between the 2 groups with or without initial heparin lead-in treatment stratified by pulmonary embolism (PE) (848 patients) and deep vein thrombosis (DVT) only (994 patients). Propensity score (PS) matching analysis was performed to balance potential baseline differences. PE and DVT patients without heparin lead-in treatment accounted for 225 (27%) and 750 (75%), respectively. PS matching provided 195 pairs of PE patients and 224 pairs of DVT patients. There was no significant difference between the no heparin and heparin groups in the cumulative 30-day incidence of all-cause death (PE: 2.6% vs. 4.2%, P = 0.40; DVT: 2.7% vs. 3.2%, P = 0.78) and a composite of all-cause death, recurrent VTE, or major bleeding (PE: 5.8% vs. 8.4%, P = 0.32; DVT: 4.6% vs. 6.4%, P = 0.41). In the current real-world VTE registry, a substantial proportion of patients with acute VTE were treated with edoxaban without initial heparin lead-in treatment. There was no obvious signal suggesting worse short-term clinical outcomes with edoxaban treatment without versus with initial heparin lead-in treatment.</p>","PeriodicalId":17546,"journal":{"name":"Journal of Thrombosis and Thrombolysis","volume":" ","pages":""},"PeriodicalIF":2.3000,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Thrombosis and Thrombolysis","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s11239-025-03105-2","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
Abstract
The package insert of edoxaban for acute venous thromboembolism (VTE) recommended administration following initial parenteral anticoagulation including heparin. We explored the effectiveness and safety of edoxaban for acute VTE without initial heparin lead-in treatment. The COMMAND VTE Registry-2 is a multicenter registry enrolling 5197 consecutive acute symptomatic VTE patients in Japan between January 2015 and August 2020. The current study population consisted of 1842 patients with acute VTE treated with edoxaban. The baseline characteristics and clinical outcomes were compared between the 2 groups with or without initial heparin lead-in treatment stratified by pulmonary embolism (PE) (848 patients) and deep vein thrombosis (DVT) only (994 patients). Propensity score (PS) matching analysis was performed to balance potential baseline differences. PE and DVT patients without heparin lead-in treatment accounted for 225 (27%) and 750 (75%), respectively. PS matching provided 195 pairs of PE patients and 224 pairs of DVT patients. There was no significant difference between the no heparin and heparin groups in the cumulative 30-day incidence of all-cause death (PE: 2.6% vs. 4.2%, P = 0.40; DVT: 2.7% vs. 3.2%, P = 0.78) and a composite of all-cause death, recurrent VTE, or major bleeding (PE: 5.8% vs. 8.4%, P = 0.32; DVT: 4.6% vs. 6.4%, P = 0.41). In the current real-world VTE registry, a substantial proportion of patients with acute VTE were treated with edoxaban without initial heparin lead-in treatment. There was no obvious signal suggesting worse short-term clinical outcomes with edoxaban treatment without versus with initial heparin lead-in treatment.
治疗急性静脉血栓栓塞(VTE)的依多沙班包装说明书推荐在初始静脉外抗凝包括肝素后给药。我们探讨了依多沙班治疗急性静脉血栓栓塞的有效性和安全性。COMMAND VTE注册-2是一项多中心注册,在2015年1月至2020年8月期间在日本招募了5197名连续急性症状性VTE患者。目前的研究人群包括1842名接受依多沙班治疗的急性静脉血栓栓塞患者。比较两组患者的基线特征和临床结果,分别为肺栓塞(PE)组(848例)和深静脉血栓形成(DVT)组(994例)。倾向评分(PS)匹配分析平衡潜在基线差异。未接受肝素导入治疗的PE和DVT患者分别占225例(27%)和750例(75%)。PS配对提供PE患者195对,DVT患者224对。无肝素组和肝素组30天全因死亡累计发生率无显著差异(PE: 2.6% vs. 4.2%, P = 0.40;DVT: 2.7% vs. 3.2%, P = 0.78)和全因死亡、静脉血栓栓塞复发或大出血的组合(PE: 5.8% vs. 8.4%, P = 0.32;DVT: 4.6% vs. 6.4%, P = 0.41)。在目前现实世界的静脉血栓栓塞登记中,相当大比例的急性静脉血栓栓塞患者在没有肝素引入治疗的情况下接受了依多沙班治疗。没有明显的信号表明,不使用依多沙班治疗与初始肝素导入治疗相比,短期临床结果更差。
期刊介绍:
The Journal of Thrombosis and Thrombolysis is a long-awaited resource for contemporary cardiologists, hematologists, vascular medicine specialists and clinician-scientists actively involved in treatment decisions and clinical investigation of thrombotic disorders involving the cardiovascular and cerebrovascular systems. The principal focus of the Journal centers on the pathobiology of thrombosis and vascular disorders and the use of anticoagulants, platelet antagonists, cell-based therapies and interventions in scientific investigation, clinical-translational research and patient care.
The Journal will publish original work which emphasizes the interface between fundamental scientific principles and clinical investigation, stimulating an interdisciplinary and scholarly dialogue in thrombosis and vascular science. Published works will also define platforms for translational research, drug development, clinical trials and patient-directed applications. The Journal of Thrombosis and Thrombolysis'' integrated format will expand the reader''s knowledge base and provide important insights for both the investigation and direct clinical application of the most rapidly growing fields in medicine-thrombosis and vascular science.