Abstract

Background

In patients with atrial fibrillation (AF) and normal or slightly impaired renal function, the use of direct oral anticoagulants (DOACs) is preferable to vitamin K antagonists (VKAs). However, in patients undergoing hemodialysis, the efficacy, and safety of DOACs compared with VKAs are still unknown.

Purpose

To review current evidence about the safety and efficacy of DOACs compared to VKAs, in patients with AF and chronic kidney disease under hemodialysis.

Methods

We systematically searched PubMed, Scopus, and Cochrane databases for RCTs comparing DOACs with VKAs for anticoagulation in patients with AF on dialysis therapy. Outcomes of interest were: (1) stroke; (2) major bleeding; (3) cardiovascular mortality; and (4) all-cause mortality. Statistical analysis was performed using RevMan 5.1.7 and heterogeneity was assessed by I² statistics.

Results

Three randomized controlled trials were included, comprising a total of 383 patients. Of these, 218 received DOACs (130 received apixaban; 88 received rivaroxaban), and 165 were treated with VKAs (116 received warfarin; 49 received phenprocoumon). The incidence of stroke was significantly lower in patients treated with DOACs (4.7%) compared with those using VKAs (9.5%) (RR 0.42; 95% CI 0.18–0.97; p = 0.04; I² = 0%). However, the difference was not statistically significant in the case of ischemic stroke specifically (RR 0.42; 95% CI 0.17–1.04; p = 0.06; I² = 0%). As for the major bleeding outcome, the DOAC group (11%) had fewer events than the VKA group (13.9%) but without statistical significance (RR 0.75; 95% CI 0.45–1.28; p = 0.29; I² = 0%). There was no significant difference between groups regarding cardiovascular mortality (RR 1.23; 95% CI 0.66–2.29; p = 0.52; I² = 13%) and all-cause mortality (RR 0.98; 95% CI 0.77–1.24; p = 0.84; I² = 16%).

Conclusion

This meta-analysis suggests that in patients with AF on dialysis, the use of DOACs was associated with a significant reduction in stroke, and a numerical trend of less incidence of major bleeding compared with VKAs, but in this case with no statistical significance. Results may be limited by a small sample size or insufficient statistical power.

中文翻译：

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房颤合并 5 期慢性肾病透析患者的直接口服抗凝剂与维生素 K 拮抗剂对比：随机对照试验的系统评价和荟萃分析

摘要

背景

对于心房颤动 (AF) 且肾功能正常或轻度受损的患者，使用直接口服抗凝剂 (DOAC) 优于维生素 K 拮抗剂 (VKA)。然而，在接受血液透析的患者中，DOAC 与 VKA 相比的疗效和安全性仍不清楚。

目的

回顾目前关于 DOAC 与 VKA 相比，对于接受血液透析的 AF 和慢性肾病患者的安全性和有效性的证据。

方法

我们系统地检索了 PubMed、Scopus 和 Cochrane 数据库中的随机对照试验，比较 DOAC 与 VKA 在接受透析治疗的 AF 患者中的抗凝作用。感兴趣的结果是：（1）中风；(2)大出血；(3)心血管死亡率；(4)全因死亡率。^{使用RevMan 5.1.7进行统计分析并通过I 2}统计评估异质性。

结果

其中包括三项随机对照试验，总共 383 名患者。其中，218 人接受 DOAC（130 人接受阿哌沙班；88 人接受利伐沙班），165 人接受 VKA 治疗（116 人接受华法林；49 人接受苯丙香豆素）。与使用 VKA 治疗的患者 (9.5%) 相比，接受 DOAC 治疗的患者中风发生率 (4.7%) 显着降低 (RR 0.42; 95% CI 0.18–0.97; p  = 0.04; I ²  = 0%)。然而，在缺血性卒中的情况下，差异并不具有统计学意义（RR 0.42；95% CI 0.17–1.04；p  = 0.06；I ²  = 0%）。至于大出血结局，DOAC 组（11%）的事件少于 VKA 组（13.9%），但没有统计学意义（RR 0.75；95% CI 0.45–1.28；p  = 0.29；I ²  = 0%） 。心血管死亡率（RR 1.23；95% CI 0.66–2.29； p  = 0.52；I ²  = 13%）和全因死亡率（RR 0.98；95% CI 0.77–1.24；p  = 0.84 ）组间没有显着差异。; I ²  = 16%）。

结论

这项荟萃分析表明，在接受透析的 AF 患者中，与 VKA 相比，使用 DOAC 可以显着减少中风，并且大出血发生率呈数字趋势减少，但在本例中没有统计学意义。结果可能受到样本量小或统计功效不足的限制。