Wang Na, Shen Nan-Nan, Wu Yue, Zhang Chi, Pan Mang-Mang, Qian Yan, Gu Zhi-Chun
Department of Pharmacy, The Second Affiliated Hospital of Chongqing Medical University, Chongqing 400010, China.
Department of Pharmacy, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China.
Ann Transl Med. 2020 Mar;8(6):391. doi: 10.21037/atm.2020.02.109.
Current evidence regarding the effectiveness and safety of direct oral anticoagulants (DOACs) in the elderly with atrial fibrillation (AF) remains scarce. Based on the emerging evidence from real-world studies (RWSs) associated with DOACs, we will perform a systematic review and meta-analysis of data from RWSs and randomized controlled trials (RCTs) to compare the effectiveness, safety and cost of DOACs versus Vitamin K antagonists (VKAs) in elderly patients with AF.
The MEDLINE, EMBASE and Cochrane Library databases will be systematically searched until June 30, 2019 for eligible RWSs and RCTs that reported the clinical outcomes between DOACs and VKAs in elderly patients with AF. The effectiveness outcome is stroke or systemic embolism (SE), and the safety outcomes are major bleeding, intracranial haemorrhage (ICH), gastrointestinal bleeding (GIB), myocardial infarction (MI) and all-cause mortality. A random-effects model will be used to calculate adjusted hazard ratios (HRs) for RWSs and relative risks (RRs) for RCTs, separately. The interaction analysis and the ratio of HRs (RHRs) will be applied to compare the treatment effect difference between RWSs and RCTs. A Markov model will be constructed to evaluate the cost-effectiveness of DOACs versus VKAs in elderly AF patients in real-world setting.
This study will summarize all available evidences from RWSs and RCTs for a comprehensive and rigorous systematic review on the effectiveness and safety associated with DOACs, as well as perform a cost-effectiveness analysis to evaluate the price performance of DOACs among elderly AF patients in real clinical setting.
PROSPERO register platform (CRD42019142881, www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID =142881).
关于直接口服抗凝剂（DOACs）在老年房颤（AF）患者中的有效性和安全性，目前的证据仍然很少。基于与DOACs相关的真实世界研究（RWSs）中不断涌现的证据，我们将对RWSs和随机对照试验（RCTs）的数据进行系统评价和荟萃分析，以比较DOACs与维生素K拮抗剂（VKAs）在老年AF患者中的有效性、安全性和成本。
将系统检索MEDLINE、EMBASE和Cochrane图书馆数据库，直至2019年6月30日，以查找报告DOACs与VKAs在老年AF患者中临床结局的合格RWSs和RCTs。有效性结局为卒中或全身性栓塞（SE），安全性结局为大出血、颅内出血（ICH）、胃肠道出血（GIB）、心肌梗死（MI）和全因死亡率。将分别使用随机效应模型计算RWSs的调整风险比（HRs）和RCTs的相对风险（RRs）。将应用交互分析和HRs比值（RHRs）来比较RWSs和RCTs之间的治疗效果差异。将构建一个马尔可夫模型来评估DOACs与VKAs在真实世界中对老年AF患者的成本效益。
本研究将总结RWSs和RCTs的所有可用证据，对与DOACs相关的有效性和安全性进行全面而严格的系统评价，并进行成本效益分析，以评估DOACs在实际临床环境中对老年AF患者的性价比。
PROSPERO注册平台（CRD42019142881，www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID =142881）。
