在接受透析的非瓣膜性心房颤动(AF)患者中,使用不同阿哌沙班剂量或华法林的抗凝方案的临床结果比较尚不明确。这项研究比较了接受维持性透析的美国国家肾衰竭患者队列中的这些结果。
回顾性队列研究。
2013-2018年美国肾脏数据系统数据库中显示的接受透析的患者患有房颤并接受阿哌沙班或华法林治疗。
根据标签服用阿哌沙班的第一次处方治疗,阿哌沙班剂量低于标签,或者华法林.
缺血性卒中/全身性栓塞,大出血,和全因死亡率。
具有治疗加权逆概率的Cox比例风险模型。还实施了模拟意向治疗(ITT)方法的分析以及在药物转换或停药(CAS)时进行审查的分析。审查权重的逆概率被用来解释可能的信息审查。
在17156人中,标记一致的阿哌沙班患者的卒中/全身性栓塞风险没有差异,下面的阿哌沙班标签,和华法林治疗组。两者标签一致(HR,0.67[95%CI,0.55-0.81])和低于标签(HR,在ITT分析中,与华法林相比,0.68[95%CI,0.55-0.84])阿哌沙班剂量与较低的大出血风险相关。与标签一致的阿哌沙班相比,低于标签的阿哌沙班与较低的出血风险无关(HR,1.02[95%CI,0.78-1.34])。在ITT死亡率分析中,与华法林相比,标签一致的阿哌沙班剂量与较低的风险相关(HR,0.85[95%CI,0.78-0.92]),而低于标签的阿哌沙班和华法林之间的死亡率没有显着差异(HR,0.97[95%CI,0.89-1.05])。总的来说,CAS分析结果相似.
研究仅限于美国医疗保险受益人;依靠行政索赔来确定AF的结果,中风,和出血;可能残留的混杂因素。
在接受透析的非瓣膜性房颤患者中,与阿哌沙班相比,华法林出血风险增加.低于标签的阿哌沙班的出血风险并不低于标签一致给药的出血风险。与华法林相比,标签一致的阿哌沙班给药与死亡率获益相关。标签-一致剂量,而不是减少标签的剂量,可能为非瓣膜性房颤透析患者提供最有利的获益-风险权衡。
Comparison of clinical outcomes across anticoagulation regimens using different apixaban dosing or warfarin is not well-defined in patients with nonvalvular atrial fibrillation (AF) who are receiving dialysis. This
study compared these outcomes in a US national cohort of patients with kidney failure receiving maintenance dialysis.
Retrospective cohort
study.
Patients receiving dialysis represented in the US Renal Data System database 2013-2018 who had AF and were treated with apixaban or warfarin.
First prescribed treatment with apixaban dosed according to the label, apixaban dosed below the label, or warfarin.
Ischemic stroke/systemic embolism, major bleeding, and all-cause mortality.
Cox proportional hazards models with inverse probability of treatment weighting. Analyses simulating an intention-to-treat (ITT) approach as well as those incorporating censoring at drug switch or discontinuation (CAS) were also implemented. Inverse probability of censoring weighting was used to account for possible informative censoring.
Among 17,156 individuals, there was no difference in risk of stroke/systemic embolism among the label-concordant apixaban, below-label apixaban, and warfarin treatment groups. Both label-concordant (HR, 0.67 [95% CI, 0.55-0.81]) and below-label (HR, 0.68 [95% CI, 0.55-0.84]) apixaban dosing were associated with a lower risk of major bleeding compared with warfarin in ITT analyses. Compared with label-concordant apixaban, below-label apixaban was not associated with a lower bleeding risk (HR, 1.02 [95% CI, 0.78-1.34]). In the ITT analysis of mortality, label-concordant apixaban dosing was associated with a lower risk versus warfarin (HR, 0.85 [95% CI, 0.78-0.92]) while there was no significant difference in mortality between below-label dosing of apixaban and warfarin (HR, 0.97 [95% CI, 0.89-1.05]). Overall, results were similar for the CAS analyses.
Study limited to US Medicare beneficiaries; reliance on administrative claims to ascertain outcomes of AF, stroke, and bleeding; likely residual confounding.
Among patients with nonvalvular AF undergoing dialysis, warfarin is associated with an increased risk of bleeding compared with apixaban. The risk of bleeding with below-label apixaban was not detectably less than with label-concordant dosing. Label-concordant apixaban dosing is associated with a mortality benefit compared to warfarin. Label-concordant dosing, rather than reduced-label dosing, may offer the most favorable benefit-risk trade-off for dialysis patients with nonvalvular AF.