Institute of Clinical Pharmacology and Toxicology, Sheba Medical Center, Tel Hashomer, Israel; Department of Medicine A, Sheba Medical Center, Tel Hashomer, Israel; Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
Institute of Clinical Pharmacology and Toxicology, Sheba Medical Center, Tel Hashomer, Israel.
Thromb Res. 2020 Dec;196:457-462. doi: 10.1016/j.thromres.2020.09.034. Epub 2020 Oct 8.
Uninterrupted drug therapy during acute illness is often associated with pharmacokinetic and pharmacodynamic variations. Among warfarin treated patients, these changes are reflected in the INR. However, in the case of direct oral anticoagulants (DOACs), given that routine laboratory monitoring is not recommended, these changes may result in unforeseen thromboembolic or bleeding events.
To determine the rate of thromboembolic (TEE) and bleeding events associated with uninterrupted DOAC compared to warfarin treatment during acute illness.
A retrospective cohort study of patients treated with DOACs or warfarin, both at steady state, who were hospitalized for acute illness. Primary outcome was any TEE or major bleeding requiring re-hospitalization within one month from discharge. Secondary outcome was a composite of major bleeding and clinically relevant non-major bleeding (CRNMB) events.
A total of 410 patients continued oral anticoagulant treatment during their hospitalization, of whom 191 (46.6%) were on DOACs and 219 (53.4%) on warfarin, with a total of 18 (4.4%) events. Rates of TEE and major bleeding events did not differ between DOACs and warfarin treated patients (0.9% vs. 0.5% and 0.5% vs. 1%, respectively). Similarly, rate of secondary outcome was comparable between DOACs (4.7%) and warfarin (2.7%, p = 0.29). Sub-analyses demonstrated significantly higher rates among rivaroxaban (10.4%) treated patients compared to warfarin (p = 0.03).
Uninterrupted treatment with DOACs during acute illness is not associated with increased risk for re-hospitalizations due to bleeding or thromboembolic events compared to warfarin. Our results suggest a higher bleeding rate among rivaroxaban treated patients at high bleeding risk.
在急性疾病期间不间断的药物治疗通常与药代动力学和药效学的变化有关。在接受华法林治疗的患者中，这些变化反映在 INR 中。然而，对于直接口服抗凝剂（DOAC），由于不建议常规进行实验室监测，这些变化可能导致意外的血栓栓塞或出血事件。
确定与急性疾病期间不间断的 DOAC 治疗相比，华法林治疗相关的血栓栓塞（TEE）和出血事件的发生率。
对接受 DOAC 或华法林治疗的患者进行回顾性队列研究，这些患者在稳定状态下接受治疗，并因急性疾病住院。主要结局是出院后一个月内任何需要再次住院的 TEE 或大出血事件。次要结局是大出血和临床上相关非大出血（CRNMB）事件的复合结果。
共有 410 例患者在住院期间继续接受口服抗凝治疗，其中 191 例（46.6%）接受 DOAC 治疗，219 例（53.4%）接受华法林治疗，共有 18 例（4.4%）事件。DOAC 和华法林治疗患者的 TEE 和大出血事件发生率无差异（0.9%比 0.5%和 0.5%比 1%）。同样，DOAC（4.7%）和华法林（2.7%）的次要结局发生率也相似（p=0.29）。亚分析显示，利伐沙班（10.4%）治疗患者的发生率明显高于华法林（p=0.03）。
与华法林相比，在急性疾病期间不间断使用 DOAC 治疗不会增加出血或血栓栓塞事件导致再次住院的风险。我们的结果表明，在高出血风险的利伐沙班治疗患者中，出血发生率更高。
