Patel Priya J, Sigala Mariah I, Dinunno Corey V, Blackburn Laura M, Donahue Kevin R
Department of Pharmacy, Houston Methodist Hospital, TX, USA.
J Pharm Pract. 2025 Sep 6:8971900251376819. doi: 10.1177/08971900251376819.
Critically ill adults are more commonly being admitted to intensive care units (ICU) with a recent history of direct oral anticoagulant (DOAC) use. No consensus guidance exists on optimal anticoagulation strategies in critically ill adults with non-valvular atrial fibrillation (NVAF) on DOAC's prior to ICU admission, and there is considerable variability in clinical practice. To evaluate rates of major bleeding and thrombosis between 2 anticoagulation strategies for NVAF upon ICU admission: package insert (continuation of oral or parenteral anticoagulation per manufacturer recommendations) vs non-package insert (prophylactic dosing or delayed therapeutic anticoagulation). This was a retrospective cohort study conducted from January 2019 to August 2023. Patients with NVAF and objective evidence of DOAC exposure within 48 hours of ICU admission were included. Those admitted to the ICU for a bleeding event or who received anticoagulation for indications other than NVAF were excluded. A total of 353 patients met inclusion criteria (122 vs 231 in the package insert and non-package insert groups, respectively). There was no significant difference in the composite incidence of major bleeding and stroke or systemic embolism between groups (4.1% in package insert vs 6.1% in non-package insert; = 0.437). This study demonstrated no difference in the incidence of major bleeding, in-hospital stroke, or systemic embolism with a package insert vs a non-package insert approach to anticoagulation in critically ill patients receiving DOAC therapy for atrial fibrillation. However, more studies are needed to develop evidence-based guidance on anticoagulation management in this population.
重症成年患者因近期使用直接口服抗凝剂(DOAC)而更常被收入重症监护病房(ICU)。对于在入住ICU前使用DOAC的非瓣膜性心房颤动(NVAF)重症成年患者,目前尚无关于最佳抗凝策略的共识指南,临床实践中存在很大差异。为了评估入住ICU时两种NVAF抗凝策略之间的大出血和血栓形成发生率:药品说明书(按照制造商建议继续口服或胃肠外抗凝)与非药品说明书(预防性给药或延迟治疗性抗凝)。这是一项从2019年1月至2023年8月进行的回顾性队列研究。纳入入住ICU 48小时内有NVAF且有DOAC暴露客观证据的患者。因出血事件入住ICU或因NVAF以外的适应症接受抗凝治疗的患者被排除。共有353名患者符合纳入标准(药品说明书组和非药品说明书组分别为122名和231名)。两组之间大出血与中风或全身性栓塞的综合发生率无显著差异(药品说明书组为4.1%,非药品说明书组为6.1%;P = 0.437)。本研究表明,对于接受DOAC治疗心房颤动的重症患者,采用药品说明书与非药品说明书抗凝方法在大出血、院内中风或全身性栓塞发生率方面无差异。然而,需要更多研究来制定该人群抗凝管理的循证指南。