直接口服抗凝剂与维生素K拮抗剂用于肝硬化合并房颤患者的疗效比较：系统评价与荟萃分析的更新
Direct Oral Anticoagulants versus Vitamin K Antagonists in Cirrhotic Patients with Atrial Fibrillation: Update of Systematic Review and Meta-Analysis.
作者信息
Hu Tong, Li Yi-Han, Han Wen-Qiang, Maduray Kellina, Chen Tong-Shuai, Hao Li, Zhong Jing-Quan
机构信息
National Key Laboratory for Innovation and Transformation of Luobing Theory; The Key Laboratory of Cardiovascular Remodeling and Function Research, Chinese Ministry of Education, Chinese National Health Commission and Chinese Academy of Medical Sciences; Department of Cardiology, Qilu Hospital of Shandong University, Jinan, China.
Department of Gerontology, The First Affiliated Hospital of Shandong First Medical University and Shandong Provincial Qianfoshan Hospital, Jinan, China.
出版信息
Am J Cardiovasc Drugs. 2023 Nov;23(6):683-694. doi: 10.1007/s40256-023-00598-1. Epub 2023 Aug 28.
BACKGROUND
Prevention of ischemic stroke is an essential part of managing atrial fibrillation (AF). In recent years, direct oral anticoagulants (DOACs) have emerged as an alternative to vitamin K antagonists (VKAs). Little is understood regarding the efficacy and safety of DOACs in AF patients with liver cirrhosis (LC).
OBJECTIVE
This meta-analysis is designed to evaluate the benefits and risks of DOACs compared to VKAs in AF patients with concomitant LC.
METHODS
A thorough search was conducted in PubMed, Cochrane Library, Web of Science, Embase, Scopus, and CNKI databases up to February 2023. A total of seven clinical studies including 7551 patients were analyzed in this meta-analysis. All data analyses were performed using Review Manager software version 5.3.
RESULTS
Regarding efficacy outcomes, DOACs had comparable clinical benefit in reducing ischemic stroke/systemic thromboembolism (HR=0.79, 95% CI [0.59, 1.06], p = 0.12) to VKAs. The incidence of all-cause death was similar between the DOACs and VKAs group (HR 0.94, 95% CI [0.69, 1.28], p = 0.69). Regarding safety outcomes, DOACs were associated with a significantly lower risk of major bleeding (HR 0.61, 95% CI [0.50, 0.75], p < 0.00001), intracranial hemorrhage (HR 0.55, 95% CI [0.31, 0.98], p = 0.04) and major gastrointestinal bleeding (HR 0.66, 95% CI [0.51, 0.85], p = 0.001) than VKAs. Additional subgroup analysis of advanced cirrhosis revealed that DOACs were associated with a significantly lower risk of major bleeding (HR 0.59, 95% CI [0.39, 0.89], p = 0.01) than VKAs. There were no significant differences between the DOACs and VKAs group concerning the incidence of ischemic stroke/systemic thromboembolism (HR 1.38, 95% CI [0.75, 2.55], p = 0.31) and major gastrointestinal bleeding (HR 0.65, 95% CI [0.41, 1.04], p = 0.08).
CONCLUSION
DOACs are associated with more favorable safety outcomes and may be a feasible option of oral anticoagulant for individuals with atrial fibrillation and cirrhosis. Pending validation by randomized prospective studies, the findings of this study should be interpreted with caution.
背景
预防缺血性中风是心房颤动（AF）管理的重要组成部分。近年来，直接口服抗凝剂（DOACs）已成为维生素K拮抗剂（VKAs）的替代药物。对于患有肝硬化（LC）的AF患者，DOACs的疗效和安全性了解甚少。
目的
本荟萃分析旨在评估DOACs与VKAs相比，在合并LC的AF患者中的益处和风险。
方法
截至2023年2月，在PubMed、Cochrane图书馆、科学网、Embase、Scopus和中国知网数据库中进行了全面检索。本荟萃分析共纳入7项临床研究，包括7551例患者。所有数据分析均使用Review Manager 5.3软件进行。
结果
在疗效结果方面，DOACs在降低缺血性中风/全身性血栓栓塞方面具有与VKAs相当的临床益处（HR=0.79，95%CI[0.59，1.06]，p=0.12）。DOACs组和VKAs组的全因死亡率相似（HR 0.94，95%CI[0.69，1.28]，p=0.69）。在安全性结果方面，与VKAs相比，DOACs发生大出血（HR 0.61，95%CI[0.50，0.75]，p<0.00001）、颅内出血（HR 0.55，95%CI[0.31，0.98]，p=0.04）和重大胃肠道出血（HR 0.66，95%CI[0.51，0.85]，p=0.001）的风险显著更低。晚期肝硬化的额外亚组分析显示，与VKAs相比，DOACs发生大出血的风险显著更低（HR 0.59，95%CI[0.39，0.89]，p=0.01）。DOACs组和VKAs组在缺血性中风/全身性血栓栓塞发生率（HR 1.38，95%CI[0.75，2.55]，p=0.31）和重大胃肠道出血发生率（HR 0.65，95%CI[0.41，1.04]，p=0.08）方面无显著差异。
结论
DOACs具有更有利的安全性结果，可能是心房颤动和肝硬化患者口服抗凝剂的可行选择。在随机前瞻性研究验证之前，本研究结果应谨慎解释。
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