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直接口服抗凝剂与标准疗法治疗上肢深静脉血栓形成的真实世界证据

Direct Oral Anticoagulants versus Standard Therapy in Upper Extremity Deep Vein Thrombosis: Real-World Evidence.

作者信息

Ruiz-Artacho Pedro, Lecumberri Ramón, Trujillo-Santos Javier, Beddar Chaib Fahd, Moustafa Farès, Lorenzo Alicia, Gómez-Cuervo Covadonga, Bosevski Marijan, Monreal Manuel

机构信息

Department of Internal Medicine, Clínica Universidad de Navarra, Madrid, Spain.

Interdisciplinar Teragnosis and Radiosomics Research Group (INTRA-Madrid), Universidad de Navarra, Madrid, Spain.

出版信息

Thromb Haemost. 2025 May 29. doi: 10.1055/a-2615-4513.

DOI:10.1055/a-2615-4513
PMID:40389231
Abstract

Evidence on the use of direct oral anticoagulants (DOACs) in upper extremity deep vein thrombosis (UEDVT) remains limited. This study examines real-world outcomes of DOACs compared with standard anticoagulation therapy for UEDVT patients.Using the RIETE (Registro Informatizado de Enfermedad TromboEmbólica) database, we conducted an observational analysis of UEDVT patients treated with DOACs or standard therapy (low molecular weight heparin [LMWH] or vitamin K antagonists for noncancer patients, and LMWH for cancer patients). Patients with events during the first 5 days of treatment were excluded. The primary outcome was a composite of venous thromboembolism (VTE) recurrence and major bleeding during the first 3 months of therapy. Multivariable and multilevel analyses were conducted to adjust for confounding.Between January 2011 and November 2023, 3,496 UEDVT patients met the inclusion criteria. Of these, 679 (19.4%) received DOACs, whereas 2,817 (80.6%) received standard therapy. The composite outcome occurred in seven patients (1.0%) on DOACs (5 [0.7%] VTE recurrence, 2 [0.3%] major bleeding) compared with 78 patients (2.8%) on standard therapy (51 [1.8%] VTE recurrence, 29 [1.0%] major bleeding;  < 0.001). Multivariable analysis showed that DOAC use was associated with a lower risk of the composite outcome (adjusted subhazard ratio: 0.41; 95% confidence interval: 0.19-0.90). These findings remained consistent in multilevel models and sensitivity analyses stratified by cancer and catheter-related thrombosis.This real-world analysis suggests that DOACs may be associated with a lower risk of VTE recurrence and major bleeding compared with standard therapy in patients with UEDVT. These findings support DOACs as a viable treatment option.

摘要

关于直接口服抗凝剂(DOACs)在上肢深静脉血栓形成(UEDVT)中的应用证据仍然有限。本研究探讨了DOACs与UEDVT患者标准抗凝治疗相比的实际疗效。利用RIETE(静脉血栓栓塞疾病信息登记处)数据库,我们对接受DOACs或标准治疗(非癌症患者使用低分子量肝素[LMWH]或维生素K拮抗剂,癌症患者使用LMWH)的UEDVT患者进行了观察性分析。排除治疗前5天内发生事件的患者。主要结局是治疗前3个月内静脉血栓栓塞(VTE)复发和大出血的复合情况。进行多变量和多水平分析以调整混杂因素。2011年1月至2023年11月期间,3496例UEDVT患者符合纳入标准。其中,679例(19.4%)接受了DOACs治疗,而2817例(80.6%)接受了标准治疗。DOACs组有7例患者(1.0%)出现复合结局(5例[0.7%]VTE复发,2例[0.3%]大出血),标准治疗组有78例患者(2.8%)出现复合结局(51例[1.8%]VTE复发,29例[1.0%]大出血;P<0.001)。多变量分析显示,使用DOACs与复合结局风险较低相关(调整后亚风险比:0.41;95%置信区间:0.19 - 0.90)。这些结果在多水平模型以及按癌症和导管相关血栓形成分层的敏感性分析中保持一致。这项真实世界分析表明,与标准治疗相比,DOACs在UEDVT患者中可能与较低的VTE复发和大出血风险相关。这些发现支持DOACs作为一种可行的治疗选择。

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