Sigala Mariah I, Dinunno Corey V, Lopez Chelsea N, Succar Luma, Petkova Jenny H, Graviss Edward A, Nguyen Duc T, Donahue Kevin R
Department of Pharmacy, Houston Methodist Hospital, Houston, TX, USA.
Hematology Division, Houston Methodist Hospital, Houston, TX, USA.
J Pharm Technol. 2025 Sep 9:87551225251372486. doi: 10.1177/87551225251372486.
The increased utilization of oral factor Xa inhibitors (FXaI) has led to a growing interest in the clinical utility of FXaI-specific anti-Xa concentrations. Critically ill populations are at risk of bleeding secondary to FXaI accumulation in the setting of end-organ dysfunction. To mitigate this risk, an FXaI anti-Xa concentration-guided approach to transitioning between oral and parenteral anticoagulation has been explored. To compare the incidence of bleeding upon intensive care unit (ICU) admission between 2 different FXaI transition strategies: concentration versus non-concentration-guided. We performed a retrospective chart review of patients admitted between January 2019 and May 2022 with objective evidence of FXaI exposure within 48 hours preceding ICU admission. Patients were excluded if they were admitted to the ICU with a primary diagnosis related to a bleeding event, received a non-FXaI anticoagulant 48 hours preceding ICU admission, remained off anticoagulation during their ICU admission, or underwent surgical procedures. The primary outcome was the incidence of major bleeding within 5 days of ICU admission. Thromboembolic events were evaluated as a secondary endpoint. A total of 433 patients (184 concentration-guided vs 249 non-concentration-guided) were included. There was no difference in major bleeding between groups (2.7% in concentration-guided vs 3.6% in non-concentration-guided; = 0.79). Thromboembolic complications were similar between groups (1.6% in concentration-guided vs 2.0% in non-concentration-guided; = 1.00) despite a longer time from last FXaI dose to anticoagulant transition in the concentration-guided group (29.9 hours vs 19.4 hours; < 0.01). Use of FXaI concentrations to guide anticoagulation transition in the ICU had no impact on major bleeding events or thromboembolic complications. Further analyses are needed to validate FXaI concentration-guided strategies and solidify anti-Xa cutoffs to create a standardized approach to FXaI transitions in the critically ill patient population.
口服凝血因子Xa抑制剂（FXaI）使用的增加，使得人们对FXaI特异性抗Xa浓度的临床应用越来越感兴趣。危重症患者因终末器官功能障碍导致FXaI蓄积而有出血风险。为降低此风险，已探索采用FXaI抗Xa浓度指导的方法在口服和胃肠外抗凝之间进行转换。比较两种不同的FXaI转换策略（浓度指导与非浓度指导）下重症监护病房（ICU）入院时的出血发生率。我们对2019年1月至2022年5月期间入院的患者进行了回顾性病历审查，这些患者在ICU入院前48小时内有FXaI暴露的客观证据。如果患者因与出血事件相关的主要诊断入住ICU、在ICU入院前48小时接受了非FXaI抗凝剂、在ICU住院期间未接受抗凝或接受了外科手术，则将其排除。主要结局是ICU入院后5天内大出血的发生率。血栓栓塞事件作为次要终点进行评估。共纳入433例患者（184例浓度指导组与249例非浓度指导组）。两组之间大出血无差异（浓度指导组为2.7%，非浓度指导组为3.6%；P = 0.79）。尽管浓度指导组从最后一剂FXaI到抗凝转换的时间更长（29.9小时对19.4小时；P < 0.01），但两组之间的血栓栓塞并发症相似（浓度指导组为1.6%，非浓度指导组为2.0%；P = 1.00）。在ICU中使用FXaI浓度指导抗凝转换对大出血事件或血栓栓塞并发症没有影响。需要进一步分析以验证FXaI浓度指导策略并确定抗Xa临界值，从而为危重症患者群体创建标准化的FXaI转换方法。
