University of Maryland School of Medicine, Baltimore, MD.
Janssen Scientific Affairs, Titusville, NJ.
Am Heart J. 2020 May;223:3-11. doi: 10.1016/j.ahj.2020.01.010. Epub 2020 Jan 22.
There is limited evidence on the effectiveness and safety of direct-acting oral anticoagulants in patients with nonvalvular atrial fibrillation (NVAF) and advanced chronic kidney disease (CKD). This study compared the risks of ischemic stroke/systemic embolism (ISSE) and major bleeding in patients with NVAF and stage IV-V CKD treated with rivaroxaban or warfarin.
Patients with NVAF and stage IV-V CKD who initiated rivaroxaban or warfarin treatment between November 2011 and June 2018 were selected from the Optum® Deidentified Electronic Health Record Database. Propensity score matching was used to balance rivaroxaban and warfarin patients on 112 measured baseline covariates. ISSE and major bleeding events over 2 years following treatment initiation were ascertained with validated end point definitions. Outcomes were analyzed as time-to-event data using Kaplan-Meier survival estimators and Cox regression.
A total of 781 eligible rivaroxaban-treated patients were propensity score-matched to 1,536 warfarin-treated patients; baseline covariates were well balanced after matching (absolute standardized differences <0.1). The average patient age was 80 years; 60.5% were female; 81.3% and 18.7% had CKD stage IV and V, respectively. Hazard ratios for rivaroxaban compared to warfarin were 0.93 (95% CI 0.46-1.90, P = .85) for the risk of ISSE and 0.91 (95% CI 0.65-1.28, P = .60) for major bleeding.
No statistically significant difference in the risk of ISSE or major bleeding was found between rivaroxaban- and warfarin-treated patients. Although further study is needed, rivaroxaban appears to be a reasonable alternative to warfarin for ISSE prevention in the setting of NVAF and stage IV-V CKD.
在非瓣膜性心房颤动（NVAF）和晚期慢性肾脏病（CKD）患者中，直接作用的口服抗凝剂的有效性和安全性证据有限。本研究比较了 NVAF 和 CKD Ⅳ-Ⅴ期患者接受利伐沙班或华法林治疗后缺血性卒中/全身性栓塞（ISSE）和主要出血的风险。
从 Optum®去识别电子健康记录数据库中选择 2011 年 11 月至 2018 年 6 月期间开始接受利伐沙班或华法林治疗的 NVAF 和 CKD Ⅳ-Ⅴ期患者。使用倾向评分匹配，在 112 个测量的基线协变量上平衡利伐沙班和华法林患者。使用验证后的终点定义确定治疗开始后 2 年内的 ISSE 和主要出血事件。使用 Kaplan-Meier 生存估计和 Cox 回归分析将结局作为时间事件数据进行分析。
共纳入 781 例符合条件的利伐沙班组患者，并与 1536 例华法林组患者进行倾向评分匹配；匹配后基线协变量平衡良好（绝对标准化差异 <0.1）。患者平均年龄为 80 岁；60.5%为女性；81.3%和 18.7%分别为 CKD Ⅳ期和Ⅴ期。与华法林相比，利伐沙班的风险比为 0.93（95%CI 0.46-1.90，P=0.85），ISSE 风险为 0.91（95%CI 0.65-1.28，P=0.60）。
利伐沙班和华法林治疗患者的 ISSE 或主要出血风险无统计学显著差异。尽管还需要进一步研究，但在 NVAF 和 CKD Ⅳ-Ⅴ期患者中，利伐沙班似乎是华法林预防 ISSE 的合理替代药物。
