Abstract

Background

Patients with nonvalvular atrial fibrillation (NVAF) and type 2 diabetes are at risk of kidney, limb, and ophthalmic complications. We evaluated the rate of these complications and death in patients with NVAF and type 2 diabetes prescribed rivaroxaban or warfarin.

Methods

We analyzed Optum de-Identified electronic health record (EHR) data from 11/2010–12/2019. We included adults with NVAF and T2D newly initiated on rivaroxaban or warfarin with ≥12 months of prior EHR activity. Patients with another indication for anticoagulation, valve disease, history of end-stage renal disease, major adverse limb events (MALE), diabetic retinopathy or pregnancy were excluded. We evaluated the incidence rate of developing a composite outcome of >40% decrease in estimated glomerular filtration incidence rate (eGFR) from baseline, eGFR < 15 mL/minute/1.73 m2, need for dialysis or kidney transplant, MALE, diabetic retinopathy or death. Overlap weighting was used to balance baseline characteristics between cohorts while preserving sample size. Hazard ratios with 95% confidence intervals were calculated using propensity score-overlap weighted Cox regression.

Results

We included 24,912 rivaroxaban and 58,270 warfarin users. The mean ± standard deviation (SD) CHA2DS2VASc score was 4.3 ± 1.5 and modified HASBLED score was 1.5 ± 0.8. Thirty percent of rivaroxaban patients were started on 15 mg once daily, with the rest prescribed 20 mg once daily. Warfarin patients had a mean time in therapeutic range of 47 ± 28%. Patients were followed for a mean of 2.89 ± 1.95 years. Rivaroxaban was associated with a reduced hazard of the composite outcome (HR = 0.93, 95%CI = 0.91–0.95; absolute risk reduction = 1.97 events per 1000 patient-years; number needed-to-treat = 51) versus warfarin. Rivaroxaban was also associated with significant reductions in the relative hazard of > 40% decrease in eGFR from baseline (HR = 0.96), need for dialysis or renal transplant (HR = 0.81), and limb revascularization or major amputation (HR = 0.85). Death occurred at a lower incidence rate with rivaroxaban (HR = 0.92, 95%CI = 0.89–0.95).

Conclusions

Rivaroxaban was associated with reduced incidence rates of kidney and limb complications, and death in NVAF patients with type 2 diabetes compared to warfarin. ClinicalTrials.gov Identifier: NCT04509193

中文翻译：

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使用利伐沙班或华法林处方的非瓣膜性房颤和 2 型糖尿病患者的肾脏、肢体和眼科并发症以及死亡：电子健康记录分析

摘要

背景

非瓣膜性心房颤动 (NVAF) 和 2 型糖尿病患者有肾脏、肢体和眼科并发症的风险。我们评估了服用利伐沙班或华法林的 NVAF 和 2 型糖尿病患者的这些并发症和死亡率。

方法

我们分析了 11/2010 至 12/2019 的 Optum 去识别电子健康记录 (EHR) 数据。我们纳入了 NVAF 和 T2D 的成年人，新近开始使用利伐沙班或华法林，并且之前有≥12 个月的 EHR 活动。排除具有其他抗凝适应症、瓣膜病、终末期肾病病史、主要不良肢体事件 (MALE)、糖尿病视网膜病变或妊娠的患者。我们评估了以下复合结局的发生率：估计肾小球滤过发生率 (eGFR) 比基线降低 > 40%、eGFR < 15 mL/分钟/1.73 m2、需要透析或肾移植、MALE、糖尿病性视网膜病变或死亡. 重叠加权用于平衡队列之间的基线特征，同时保留样本量。

结果

我们纳入了 24,912 名利伐沙班和 58,270 名华法林使用者。平均值 ± 标准差 (SD) CHA2DS2VASc 评分为 4.3 ± 1.5，修正 HASBLED 评分为 1.5 ± 0.8。30% 的利伐沙班患者开始时每天服用 15 毫克，其余患者每天服用 20 毫克。华法林患者在治疗范围内的平均时间为 47 ± 28%。患者的平均随访时间为 2.89 ± 1.95 年。与华法林相比，利伐沙班降低了复合结局的风险（HR = 0.93，95%CI = 0.91–0.95；绝对风险降低 = 1.97 事件/1000 患者年；需要治疗的数量 = 51）。利伐沙班还与 eGFR 比基线降低 > 40% 的相对风险显着降低（HR = 0.96）、需要透析或肾移植（HR = 0.81）相关，和肢体血运重建或大截肢（HR = 0.85）。利伐沙班组的死亡发生率较低（HR = 0.92，95%CI = 0.89–0.95）。

结论

与华法林相比，利伐沙班可降低 NVAF 2 型糖尿病患者的肾脏和肢体并发症的发生率以及死亡率。ClinicalTrials.gov 标识符： NCT04509193