一项关于慢性肾脏病和透析合并心房颤动患者使用直接口服抗凝剂的系统评价。
A systematic review of direct oral anticoagulant use in chronic kidney disease and dialysis patients with atrial fibrillation.
机构信息
Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada.
Library and Information Services, University Health Network, Toronto, ON, Canada.
出版信息
Nephrol Dial Transplant. 2019 Feb 1;34(2):265-277. doi: 10.1093/ndt/gfy031.
BACKGROUND
There is a lack of clear benefit and a potential risk of bleeding with direct oral anticoagulant (DOAC) use in chronic kidney disease (CKD) and dialysis patients with atrial fibrillation. The objective of this study was to evaluate how treatment with DOACs affects stroke and bleeding outcomes compared with warfarin or aspirin.
METHODS
We conducted a systematic review of randomized controlled trials, cohort studies and case series, and searched electronic databases from 1946 to 2017. Studies evaluating stroke and bleeding outcomes with DOAC use in CKD and dialysis patients were included.
RESULTS
From 8008 studies, 10 met the inclusion criteria. For moderate CKD patients (estimated glomerular filtration rate <60 mL/min/1.73 m2), there was no difference in stroke outcomes between dabigatran 110 mg [hazard ratio (HR) 0.78, 95% confidence interval (95% CI) 0.51-1.21], rivaroxaban (HR 0.82-0.84, 95% CI 0.25-2.69) and edoxaban (HR 0.87, 95% CI 0.65-1.18) versus warfarin. Dabigatran (150 mg twice daily) and apixaban reduced risk of stroke or systemic embolism significantly more than warfarin for moderate CKD patients (HR 0.55, 95% CI 0.34-0.89 and HR 0.61, 95% CI 0.39-0.94, respectively). Edoxaban and apixaban were associated with reduced major bleeding events (HR 0.50-0.76) compared with warfarin. Rivaroxaban and dabigatran 110 mg and 150 mg showed no significant difference in major bleeding versus warfarin. In hemodialysis (HD) patients, there was no difference in stroke outcomes between apixaban, dabigatran [relative risk (RR) 1.71, 95% CI 0.97-2.99] or rivaroxaban (RR 1.8, 95% CI 0.89-3.64) versus warfarin. In HD patients, rivaroxaban and dabigatran were associated with an increased major bleeding risk (RR 1.45-1.76), whereas there was no major bleeding difference with apixaban compared to warfarin.
LIMITATIONS
The heterogeneity of major bleeding and stroke definitions of the 10 included studies.
CONCLUSIONS
Clinicians should continue to weigh the risk of stroke versus bleeding before prescribing DOACs in the CKD and dialysis population.
背景
在伴有房颤的慢性肾脏病（CKD）和透析患者中，直接口服抗凝剂（DOAC）的使用缺乏明确的获益，且存在出血风险。本研究旨在评估 DOAC 治疗与华法林或阿司匹林相比，对卒中及出血结局的影响。
方法
我们对随机对照试验、队列研究和病例系列进行了系统评价，并从 1946 年至 2017 年检索了电子数据库。纳入了评估 CKD 和透析患者中 DOAC 使用与卒中及出血结局的研究。
结果
从 8008 项研究中，有 10 项符合纳入标准。对于中重度 CKD 患者（估算肾小球滤过率＜60ml/min/1.73m2），达比加群 110mg[风险比（HR）0.78，95%置信区间（95%CI）0.51-1.21]、利伐沙班（HR 0.82-0.84，95%CI 0.25-2.69）和依度沙班（HR 0.87，95%CI 0.65-1.18）与华法林的卒中结局无差异。达比加群（150mg，每日两次）和阿哌沙班可显著降低中重度 CKD 患者的卒中或全身性栓塞风险，与华法林相比，风险分别降低 55%（95%CI 0.34-0.89）和 61%（95%CI 0.39-0.94）。与华法林相比，依度沙班和阿哌沙班的大出血事件风险降低（HR 0.50-0.76）。利伐沙班和达比加群 110mg 和 150mg 与华法林相比，大出血无显著差异。在血液透析（HD）患者中，阿哌沙班、达比加群[相对风险（RR）1.71，95%CI 0.97-2.99]或利伐沙班（RR 1.8，95%CI 0.89-3.64）与华法林的卒中结局无差异。在 HD 患者中，利伐沙班和达比加群与大出血风险增加相关（RR 1.45-1.76），而与华法林相比，阿哌沙班无大出血差异。
局限性
10 项纳入研究的大出血和卒中定义存在异质性。
结论
在 CKD 和透析人群中，临床医生在开具 DOAC 处方前，应继续权衡卒中风险与出血风险。
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