The George Institute for Global Health, UNSW Sydney.
Department of Nephrology, St. George Hospital, Sydney, New South Wales, Australia.
Curr Opin Nephrol Hypertens. 2019 May;28(3):251-261. doi: 10.1097/MNH.0000000000000493.
The direct oral anticoagulants (DOACs) have emerged as an effective and safe alternative to vitamin K antagonists (VKAs) for stroke and venous thromboembolism (VTE) prevention. However, patients with chronic kidney disease (CKD) experience an increase in the risk of both thromboembolism and bleeding, and the risk-benefit profile of DOACs, particularly in advanced CKD remains a source of ongoing debate. This review summarizes the recent evidence on the effects of DOACs in CKD across a range of clinical indications including newly emerging indications.
Data on early-to-moderate stage CKD derived from pivotal randomized controlled trials in broader atrial fibrillation and VTE populations support the favorable risk-benefit ratio of DOACs compared with VKAs in patients in these groups. However, safety data from observational studies comparing DOACs with VKAs in patients with atrial fibrillation and CKD (moderate to advanced) have been conflicting. Recent trials have evaluated the efficacy of low-dose DOACs on major cardiovascular outcomes, showing promising risk-benefit ratios in high-risk populations with concurrent CKD.
Current data on patients with CKD derived from trials in the broader population suggest that DOACs are an effective alternative to VKAs in patients with early-to-moderate stage CKD. However, studies on patients with advanced CKD are lacking. Further randomized controlled trials, particularly those evaluating the risk of any clinically relevant bleeding as part of a more accurate assessment of the risk-benefit profile of DOACs in people with CKD, are needed.
直接口服抗凝剂（DOACs）在预防中风和静脉血栓栓塞（VTE）方面，已成为维生素 K 拮抗剂（VKAs）的有效且安全的替代品。然而，慢性肾脏病（CKD）患者发生血栓栓塞和出血的风险均增加，DOACs 的风险效益比，尤其是在晚期 CKD 中，仍然存在争议。本综述总结了 DOACs 在各种临床适应证（包括新出现的适应证）中在 CKD 患者中的近期证据。
来自更广泛的心房颤动和 VTE 人群的关键随机对照试验中的早期至中度 CKD 数据支持 DOACs 与 VKAs 相比，在这些人群中的患者中具有有利的风险效益比。然而，在心房颤动和 CKD（中至晚期）患者中比较 DOACs 与 VKAs 的观察性研究中的安全性数据存在矛盾。最近的试验评估了低剂量 DOACs 对主要心血管结局的疗效，在伴有 CKD 的高危人群中显示出有前景的风险效益比。
来自更广泛人群的试验中得出的 CKD 患者的现有数据表明，DOACs 在早期至中度 CKD 患者中是 VKAs 的有效替代物。然而，缺乏关于晚期 CKD 患者的研究。需要进一步的随机对照试验，特别是那些评估任何临床相关出血风险的试验，以便更准确地评估 DOACs 在 CKD 患者中的风险效益比。
