Jones Kaitlyn, Pham Caroline, Aguilar Christine, Sheth Shaila
is a Clinical Pharmacy Specialist in Primary Care at the University of Kansas Health System in Kansas City, Kansas. , and are Clinical Pharmacy Specialists in Internal Medicine at the Michael E. DeBakey Veterans Affairs Medical Center in Houston, Texas. Caroline Pham, Christine Aguilar, and Shaila Sheth are Clinical Instructors at the Baylor College of Medicine in Houston.
Fed Pract. 2020 Oct;37(10):479-485. doi: 10.12788/fp.0058.
Patients with cirrhosis needing anticoagulation therapy have historically been prescribed warfarin. New retrospective research has concluded that in patients with cirrhosis direct oral anticoagulants (DOACs) have similar or lower bleeding rates compared with that of warfarin. This study compares the safety and efficacy of DOACs with that of warfarin in patients with cirrhosis.
A retrospective chart review was conducted in adult patients with cirrhosis taking either apixaban, dabigatran, edoxaban, rivaroxaban, or warfarin. Exclusion criteria consisted of patients prescribed triple antithrombotic therapy (dual antiplatelet therapy plus an anticoagulant) and indications other than nonvalvular atrial fibrillation (NVAF) and venous thromboembolism (VTE). The primary endpoint was all-cause bleeding, and the secondary endpoints were failed efficacy and major bleeding as defined by the International Society on Thrombosis and Haemostasis in 2005. Failed efficacy was a combination endpoint including the development of VTE, stroke, myocardial infarction and/or death. Patient data were collected from the Computerized Patient Record System from October 31, 2014 to October 31, 2018.
The study included 42 patients in the DOAC group and 37 patients in the warfarin group. Baseline characteristics were not significantly different between groups except for the Child-Turcotte-Pugh score, Model for End-Stage Liver Disease score, international normalized ratio, and number of days on anticoagulation therapy. The rate of all-cause bleeding in the DOAC group was 16.7% (n = 7) vs 21.6% (n = 8) in the warfarin group ( = .7). The rate of major bleeding in the DOAC group was 2.4% (n = 1) vs 5.4% (n = 2) in the warfarin group ( = .6). The rate of failed efficacy in the DOAC group was 7.1% (n = 3) compared with 8.1% (n = 3) in the warfarin group ( = .9). Subgroup analysis of allcause bleeding did not identify any significant trends between groups.
There were no statistically significant differences identified between the rates of all-cause bleeding, major bleeding, and failed efficacy between the DOACs and warfarin groups. DOACs may be a safe alternative to warfarin in patients with cirrhosis requiring anticoagulation for NVAF or VTE, but large randomized trials are required to confirm these results.
以往，需要抗凝治疗的肝硬化患者一直使用华法林。新的回顾性研究得出结论，在肝硬化患者中，直接口服抗凝剂（DOACs）的出血率与华法林相似或更低。本研究比较了DOACs与华法林在肝硬化患者中的安全性和有效性。
对服用阿哌沙班、达比加群、依度沙班、利伐沙班或华法林的成年肝硬化患者进行回顾性病历审查。排除标准包括接受三联抗栓治疗（双联抗血小板治疗加一种抗凝剂）的患者以及非瓣膜性心房颤动（NVAF）和静脉血栓栓塞（VTE）以外的适应症患者。主要终点是全因出血，次要终点是疗效不佳和大出血，大出血定义为2005年国际血栓与止血学会所定义的大出血。疗效不佳是一个综合终点，包括VTE、中风、心肌梗死和/或死亡的发生。患者数据收集自2014年10月31日至2018年10月31日的计算机化患者记录系统。
DOAC组纳入42例患者，华法林组纳入37例患者。除了Child-Turcotte-Pugh评分、终末期肝病模型评分、国际标准化比值和抗凝治疗天数外，两组的基线特征无显著差异。DOAC组的全因出血率为16.7%（n = 7），而华法林组为21.6%（n = 8）（P = 0.7）。DOAC组的大出血率为2.4%（n = 1），而华法林组为5.4%（n = 2）（P = 0.6）。DOAC组的疗效不佳率为7.1%（n = 3），而华法林组为8.1%（n = 3）（P = 0.9）。全因出血的亚组分析未发现两组之间有任何显著趋势。
DOAC组和华法林组在全因出血率、大出血率和疗效不佳率方面未发现有统计学意义的差异。对于因NVAF或VTE需要抗凝治疗的肝硬化患者，DOACs可能是华法林的安全替代药物，但需要大型随机试验来证实这些结果。
