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利伐沙班与华法林相比在亚洲非瓣膜性心房颤动患者中的肾脏结局:一项基于全国人群的队列研究。

Renal outcomes of rivaroxaban compared with warfarin in Asian patients with nonvalvular atrial fibrillation: A nationwide population-based cohort study.

作者信息

Lee So-Ryoung, Choi Eue-Keun, Park Sang-Hyun, Han Kyung-Do, Oh Seil, Abdelgawwad Khaled, Lip Gregory Y H

机构信息

Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.

Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.

出版信息

Front Cardiovasc Med. 2023 Feb 23;10:1040834. doi: 10.3389/fcvm.2023.1040834. eCollection 2023.

Abstract

BACKGROUND

Further studies are needed to expand the evidence for the association of rivaroxaban with a lower risk of adverse renal outcomes in patients with atrial fibrillation (AF) as compared with warfarin, especially in Asians.

OBJECTIVES

To determine whether there are differences in adverse renal outcomes between rivaroxaban and warfarin-treated AF patients.

METHODS

Using the Korean nationwide claims database partly linked to laboratory results, patients with AF who initiated warfarin or rivaroxaban from 1 January 2014 to 31 December 2017 were identified. Inverse probability of treatment weighting (IPTW) was used to balance the baseline characteristics of the two groups. The primary outcome (kidney failure) was defined as the need for maintenance dialysis or having kidney transplantation. For the exploratory analysis in a subset of patients with baseline and follow-up laboratory results, the composite of renal outcomes, including estimated glomerular filtration rate (eGFR) lower than 15 ml/min/1.73 m at follow-up measurement, starting dialysis, or having kidney transplantation, ≥ 30% decline in eGFR, doubling of serum creatinine level, and acute kidney injury (AKI) were evaluated. The two groups were compared using Cox proportional hazards regression in the weighted population.

RESULTS

We identified 30,933 warfarin users and 17,013 rivaroxaban users (51% of low dose rivaroxaban). After IPTW, the mean age was 70 years, and the mean CHADS-VASc score was 3.9 in both groups. During a median follow-up of 0.93 (interquartile ranges 0.23-2.10) years, weighted incidence rates of kidney failure for warfarin and rivaroxaban were 0.83 and 0.32 per 100 person-years, respectively. Compared with the warfarin group, the rivaroxaban group was associated with a lower risk of kidney failure (hazard ratio [HR] 0.389, 95% confidence interval [CI] 0.300-0.499,  < 0.001). In patients with preexisting chronic kidney disease or eGFR ≤ 60 ml/min/1.73 m, rivaroxaban was more beneficial than warfarin in reducing the risk of kidney failure. For the composite of five renal outcomes in the exploratory analysis, the rivaroxaban group showed a lower risk than warfarin (HR 0.798, 95% CI 0.713-0.892,  < 0.001).

CONCLUSION

Rivaroxaban was associated with lower risks of renal adverse outcomes than warfarin in Korean patients with AF.

摘要

背景

需要进一步研究以扩大与华法林相比,利伐沙班在房颤(AF)患者中降低不良肾脏结局风险的证据,尤其是在亚洲人中。

目的

确定利伐沙班和华法林治疗的房颤患者在不良肾脏结局方面是否存在差异。

方法

利用部分与实验室结果相关联的韩国全国索赔数据库,识别出2014年1月1日至2017年12月31日开始使用华法林或利伐沙班的房颤患者。采用治疗权重的逆概率(IPTW)来平衡两组的基线特征。主要结局(肾衰竭)定义为需要维持性透析或进行肾脏移植。对于有基线和随访实验室结果的患者子集进行探索性分析,评估肾脏结局的综合指标,包括随访测量时估计肾小球滤过率(eGFR)低于15 ml/min/1.73 m²、开始透析或进行肾脏移植、eGFR下降≥30%、血清肌酐水平翻倍以及急性肾损伤(AKI)。在加权人群中使用Cox比例风险回归对两组进行比较。

结果

我们识别出30933名华法林使用者和17013名利伐沙班使用者(51%为低剂量利伐沙班)。经过IPTW后,两组的平均年龄均为70岁,平均CHADS-VASc评分为3.9。在中位随访0.93(四分位间距0.23 - 2.10)年期间,华法林和利伐沙班的肾衰竭加权发病率分别为每100人年0.83和0.32。与华法林组相比,利伐沙班组肾衰竭风险较低(风险比[HR] 0.389,95%置信区间[CI] 0.300 - 0.499,P < 0.001)。在已有慢性肾脏病或eGFR≤60 ml/min/1.73 m²的患者中,利伐沙班在降低肾衰竭风险方面比华法林更有益。在探索性分析中的五项肾脏结局综合指标方面,利伐沙班组显示出比华法林更低的风险(HR 0.798,95% CI [0.713 - 0.892],P < 0.001)。

结论

在韩国房颤患者中,利伐沙班与华法林相比,肾脏不良结局风险更低。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5624/9996329/d5a7a08ce383/fcvm-10-1040834-g001.jpg

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