Department of Pharmacy, Taipei Medical University Hospital, Taipei, Taiwan.
School of Pharmacy, College of Pharmacy, Taipei Medical University, Taipei, Taiwan.
PLoS One. 2021 Apr 8;16(4):e0249940. doi: 10.1371/journal.pone.0249940. eCollection 2021.
The optimal anticoagulant for end-stage renal disease patients for stroke prophylaxis is unknown. The efficacy and safety of warfarin in this population are debatable. In addition, real-world evidence of direct oral anticoagulants in patients with end-stage renal disease is limited. The aim of this study was to evaluate the clinical outcomes of rivaroxaban compared with warfarin in Taiwanese patients with end-stage renal disease with nonvalvular atrial fibrillation in a real-world setting.
This was a retrospective population-based cohort study conducted using Taiwan's National Health Insurance Research Database. Patients with nonvalvular atrial fibrillation and end-stage renal disease who started on rivaroxaban or warfarin between February 2013 and September 2017 were eligible to participate in the study. The inverse probability of treatment weighting approach was used to balance baseline characteristics. Bleeding and thromboembolic outcomes were compared using competing risk analyses. The study population consisted of 3358 patients (173 and 3185 patients on rivaroxaban and warfarin, respectively). In the rivaroxaban group, 50.8%, 38.7%, and 10.4% of the patients received 10, 15, and 20 mg of the drug, respectively. The cumulative incidence of major bleeding was similar between the two groups; however, the gastrointestinal bleeding rate was lower in the rivaroxaban group (adjusted subdistribution hazard ratio [SHR]: 0.56, 95% confidence interval [CI]: 0.34-0.91) than in the warfarin group. Furthermore, the composite risk of ischemic stroke or systemic embolism was significantly lower in the rivaroxaban group (adjusted SHR: 0.36, 95% CI: 0.17-0.79). Similar findings were observed for patients who received 10 mg of rivaroxaban.
In Taiwanese patients with end-stage renal disease and nonvalvular atrial fibrillation, rivaroxaban may be associated with a similar risk of major bleeding but a lower risk of thromboembolism compared with warfarin. The potential benefit of 10 mg of rivaroxaban in this population requires further investigation.
对于预防卒中等并发症，终末期肾病患者的最佳抗凝药物尚不明确。华法林在该人群中的疗效和安全性存在争议。此外，关于终末期肾病患者使用直接口服抗凝剂的真实世界证据有限。本研究旨在评估利伐沙班与华法林在台湾地区非瓣膜性房颤伴终末期肾病患者中的临床疗效。
这是一项基于人群的回顾性队列研究，使用了台湾全民健康保险研究数据库。2013 年 2 月至 2017 年 9 月期间开始使用利伐沙班或华法林的非瓣膜性房颤伴终末期肾病患者符合入组条件。采用逆概率治疗加权法平衡基线特征。采用竞争风险分析比较出血和血栓栓塞结局。研究人群包括 3358 例患者（利伐沙班组 173 例，华法林组 3185 例）。利伐沙班组中，分别有 50.8%、38.7%和 10.4%的患者接受 10、15 和 20mg 剂量的药物治疗。两组主要出血的累积发生率相似；然而，利伐沙班组胃肠道出血发生率较低（校正后的亚分布风险比 [SHR]：0.56，95%置信区间 [CI]：0.34-0.91）。此外，利伐沙班组缺血性卒中和全身性栓塞的复合风险显著较低（校正后的 SHR：0.36，95%CI：0.17-0.79）。接受 10mg 利伐沙班的患者也观察到了相似的结果。
在台湾地区非瓣膜性房颤伴终末期肾病患者中，与华法林相比，利伐沙班的大出血风险相似，但血栓栓塞风险较低。该人群中 10mg 利伐沙班的潜在获益尚需进一步研究。
