Periinterventional Management of Edoxaban in Major Procedures: Results from the DRESDEN NOAC REGISTRY.

Christina Köhler, Luise Tittl, Ulrike Hänsel, Evelyn Hammermüller, Sandra Marten, Christiane Naue, Marianne Spindler, Laura Stannek, Kristina Fache, Jan Beyer-Westendorf
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Abstract

Background  Edoxaban is a non-vitamin K dependent oral anticoagulant (NOAC) licensed for venous thromboembolism (VTE) treatment or stroke prevention in atrial fibrillation. Major surgical procedures are not uncommon in anticoagulated patients but data on perioperative edoxaban management are scarce. Patients and Methods  Using data from the prospective DRESDEN NOAC REGISTRY, we extracted data on major surgical procedures in edoxaban patients. Periinterventional edoxaban management patterns and rates of outcome events were evaluated until day 30 after procedure. Results  Between 2011 and 2021, 3,448 procedures were identified in edoxaban patients, including 287 (8.3%) major procedures. A scheduled interruption of edoxaban was observed in 284/287 major procedures (99%) with a total median edoxaban interruption time of 11.0 days (25-75th percentile: 5.0-18.0 days). Heparin bridging was documented in 183 procedures (46 prophylactic dosages, 111 intermediate and 26 therapeutic dosages). Overall, 7 (2.4%; 95% CI: 1.2-4.9%) major cardiovascular events (5 VTE, 2 arterial thromboembolic events) and 38 major bleedings (13.2%; 95% CI: 9.8-17.7%) were observed and 6 patients died (2.1%; 95% CI: 1.0-4.5%). Rates of major cardiovascular events with or without heparin bridging were comparable (4/137; 2.9%; 95% CI: 1.1-7.3% vs. 3/82; 3.7%; 95% CI: 1.3-10.2%). Major bleedings occurred numerically more frequent in patients receiving heparin bridging (23/137; 16.8%; 95% CI: 11.5-23.9%) versus procedures without heparin bridging (9/82; 11.0%; 95% CI: 5.9-19.6%). Conclusion  Within the limitations of our study design, real-world periprocedural edoxaban management seems effective and safe. Use of heparin bridging seems to have limited effects on reducing vascular events but may increase bleeding risk.

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依多沙班在主要手术中的介入治疗:来自DREDEN NOAC注册中心的结果。
背景 依多沙班是一种非维生素K依赖性口服抗凝剂(NOAC),用于心房颤动的静脉血栓栓塞症(VTE)治疗或中风预防。主要的外科手术在抗凝患者中并不罕见,但关于依多沙班围手术期管理的数据很少。患者和方法 使用前瞻性DREDEN NOAC REGISTRY的数据,我们提取了依多沙班患者的主要外科手术数据。在手术后第30天之前评估介入期依多沙班的管理模式和结果事件发生率。后果 2011年至2021年间,在依多沙班患者中发现了3448例手术,其中287例(8.3%)为主要手术。在284/287例主要手术中观察到依多沙班的计划中断(99%),依多沙班总中位中断时间为11.0天(25-75百分位:5.0-18.0天)。在183个程序中记录了肝素桥接(46个预防剂量,111个中间剂量和26个治疗剂量)。全面的观察到7例(2.4%;95%置信区间:1.2-4.9%)主要心血管事件(5例VTE,2例动脉血栓栓塞事件)和38例主要出血(13.2%;95%置信度:9.8-17.7%),6例患者死亡(2.1%;95%置信指数:1.0-4.5%)。有或没有肝素桥接的主要心血管事件发生率具有可比性(4/137;2.9%;95%可信区间:1.1-7.3%vs.3/82;3.7%;95%可信指数:1.3-10.2%)接受肝素桥接的患者发生率更高(23/137;16.8%;95%可信区间:11.5-23.9%),而不接受肝素桥接(9/82;11.0%;95%置信区间:5.9-19.6%)。结论 在我们研究设计的限制范围内,现实世界中的围手术期依多沙班管理似乎是有效和安全的。肝素桥接在减少血管事件方面的作用似乎有限,但可能会增加出血风险。
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