The Atrial Fibrillation-Factor Identification to Risk Modification Study in CKD/ESRD

项目摘要/摘要 超过150万美国人患有晚期慢性肾脏疾病或不可逆转的肾脏 需要透析或肾移植的失败。房颤是最常见的心脏 在肾病患者中特别常见的节律紊乱： 四分之一的不可逆性肾功能衰竭患者有心房颤动。患有心房疾病的人 纤颤发生血栓栓子事件的风险增加，尤其是中风和死亡。口头的 一般情况下，抗凝(用药丸稀释血液)已被证明可以降低这些风险。 无严重肾脏疾病的人群。而维生素K阻滞剂华法林已经被 对此的主要治疗方法，它被包括许多重要的缺陷所破坏 与其他药物或食物的相互作用以及通过以下方式经常监测治疗的需要 定期验血并调整剂量。然而，自2010年以来，一种新的药物类别已经出现 并开始替代华法林。这些所谓的直接口服抗凝剂(DOAC)可以 不需要血液监测，相互作用较少，可以按固定剂量服用。 然而，缺乏各种预防缺血性中风的策略和证据。 伴有心房颤动的晚期肾病患者的死亡率。 拟议的项目将侧重于对有效性和安全性的综合评估 这些较新的DOAC在晚期慢性肾脏疾病患者和 不可逆转的肾衰竭。我们将在两个群体中检验所有假设：a)目标1：医疗保险- 被诊断为慢性肾脏病4期或5期(非透析)的投保人；和 目的2：不可逆性肾功能衰竭患者接受透析。患者将被要求 也会被诊断为房颤。然后我们将比较重要事件的发生情况 接受华法林的人与使用DOAC之一的人之间的事件。学习 值得关注的结果将包括中风、心脏病发作、出血事件和死亡。在目标3中，我们 将确定新诊断为心房颤动的透析患者 不服用任何口服抗凝药物，并比较以下患者的相同结果 对其他相似的患者开始DOAC治疗，而不开始任何口服抗凝。我们 将使用复杂的统计方法和分析来实现公平的比较 治疗组，尽可能在不进行随机试验的情况下进行。我们的 这些发现将填补一个重要的证据空白，并有可能立即产生影响 临床实践，从而改善患者的预后。

Project Summary/Abstract More than 1.5 million Americans have advanced chronic kidney disease or irreversible kidney failure requiring dialysis or kidney transplantation. Atrial fibrillation is the most common heart rhythm disorder which is particularly common among patients with kidney disease: more than a quarter of patients with irreversible kidney failure have atrial fibrillation. Persons with atrial fibrillation are at increased risk of thromboembolic events, especially stroke, and death. Oral anticoagulation (blood dilution using pills) has been shown to reduce these risks in the general population free from advanced kidney disease. While warfarin, a vitamin K blocker, has been the mainstay treatment for this, it is marred by important shortfalls including numerous interactions with other drugs or foods and the need to frequently monitor treatment through regular blood tests and adjust the dose. However, since 2010 a new class of drugs has come to market and started to replace warfarin. These so called direct oral anticoagulants (DOACs) do not require blood monitoring, have fewer interactions, and can be taken at a fixed dose. However, the evidence is lacking on various strategies for the prevention of ischemic stroke and mortality in patients with advanced kidney disease who also have atrial fibrillation. The proposed project will focus on a comprehensive evaluation of the effectiveness and safety of these newer DOACs in patients with advanced chronic kidney disease and among those with irreversible kidney failure. We will examine all hypotheses in 2 populations: a) Aim 1: Medicare- insured persons with diagnosed chronic kidney disease stages 4 or 5 (not on dialysis); and b) Aim 2: persons with irreversible kidney failure undergoing dialysis. Patients will be required to also be diagnosed with atrial fibrillation. We will then compare the occurrence of important events between persons receiving warfarin to persons using one of the DOACs. Study outcomes of interest will include stroke, heart attacks, bleeding events, and deaths. In Aim 3, we will identify patients on dialysis with newly diagnosed with atrial fibrillation who had previously not taken any oral anticoagulation and compare the same outcomes between patients who initiated DOAC treatment to otherwise similar patients not initiating any oral anticoagulation. We will use sophisticated statistical methods and analyses to achieve fair comparisons between treatment groups, as much as is possible without conducting a randomized experiment. Our findings will fill an important evidence gap and have the potential to immediately influence clinical practice, thus improving patient outcomes.