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Management of edoxaban therapy and clinical outcomes in patients undergoing major or nonmajor surgery: a subanalysis of the EMIT-AF/VTE study
Thrombosis Journal ( IF 3.1 ) Pub Date : 2023-12-14 , DOI: 10.1186/s12959-023-00568-2
Christian von Heymann , Martin Unverdorben , Paolo Colonna , Amparo Santamaria , Manish Saxena , Thomas Vanassche , Sabine Köhler , Amanda P. Borrow , James Jin , Cathy Chen

Optimising periprocedural management of direct oral anticoagulation in patients with atrial fibrillation on chronic treatment undergoing major surgeries is an important aspect of balancing the risk of surgery-related bleeding with the risk of thromboembolic events, which may vary by surgery type. This subanalysis of the prospective EMIT-AF/VTE programme assessed periprocedural-edoxaban management, according to physicians’ decisions, and bleeding and thromboembolic event rates in patients who underwent major vs. nonmajor surgeries. Edoxaban interruption and clinical outcomes were compared between major vs. nonmajor surgeries and between renal function subgroups (creatinine clearance [CrCL] ≤ 50 mL/min vs. > 50 mL/min). We included 276 major and 512 nonmajor surgeries. The median pre- and postprocedural duration of edoxaban interruption in major vs. nonmajor surgeries was 4 vs. 1 days, whereas median duration of interruption for those with preprocedural-only and postprocedural-only interruption was 2 vs. 1 days and 2 vs. 0 days, respectively (P < 0.0001). Rates of all bleeding and clinically relevant nonmajor bleeding were numerically higher in major vs. nonmajor surgeries. Event rates (number of events per 100 surgeries) were low overall (< 6 events per 100 surgeries), independent of renal function subgroups. In this subanalysis of the EMIT-AF/VTE programme, periprocedural-edoxaban interruption was significantly longer in patients undergoing major vs. nonmajor surgery. This clinician-driven approach was associated with low rates of bleeding and thromboembolic events following both major and nonmajor surgeries. NCT02950168, registered October 31, 2016; NCT02951039, registered November 1, 2016.

中文翻译:


艾多沙班治疗的管理和接受重大或非重大手术患者的临床结果:EMIT-AF/VTE 研究的亚分析



优化长期接受大手术的房颤患者直接口服抗凝药物的围手术期管理是平衡手术相关出血风险与血栓栓塞事件风险的一个重要方面,血栓栓塞事件风险可能因手术类型而异。这项前瞻性 EMIT-AF/VTE 项目的子分析根据医生的决定评估了围手术期艾多沙班管理,以及接受大型手术和非大型手术的患者的出血和血栓栓塞事件发生率。比较主要手术与非主要手术之间以及肾功能亚组之间的艾多沙班中断和临床结果(肌酐清除率[CrCL] ≤ 50 mL/min vs. > 50 mL/min)。我们纳入了 276 例大型手术和 512 例非大型手术。大型手术与非大型手术中艾多沙班中断的中位持续时间分别为 4 天和 1 天,而仅术前和仅术后中断的患者的中位中断时间分别为 2 天和 1 天以及 2 天和 0 天天,分别(P < 0.0001)。大型手术的所有出血率和临床相关的非大出血率在数值上高于非大手术。事件发生率(每 100 次手术的事件数)总体较低(每 100 次手术< 6 次事件),与肾功能亚组无关。在 EMIT-AF/VTE 项目的子分析中,与非大型手术患者相比,接受大手术的患者围手术期艾多沙班中断时间明显更长。这种临床医生驱动的方法与大型和非大型手术后出血和血栓栓塞事件的发生率较低有关。 NCT02950168,2016年10月31日注册; NCT02951039,2016 年 11 月 1 日注册。
更新日期:2023-12-15
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