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

CKD/ESRD 风险调整研究的心房颤动因素识别

• 批准号: 10319987
• 负责人: WOLFGANG CHRISTOPH WINKELMAYER
• 金额: $ 52.53万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-01 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10319987
• 关键词: Adherence; American; Anticoagulants; Anticoagulation; Area; Arrhythmia; Atrial Fibrillation; Binding Proteins; Biometry; Black Populations; Blood; Blood Tests; Cardiovascular system; Cessation of life; Chronic Kidney Failure; Complex; Conflict (Psychology); Data; Databases; Diagnosis; Dialysis procedure; Disease; Dose; Effectiveness; Electrophysiology (science); Embolism; End stage renal failure; Enrollment; Epidemiology; Erythropoiesis; Evaluation; Event; Factor V; Female; Ferritin; Food; Foundations; Funding; Future; General Population; Germany; Hemoglobin; Hemorrhage; Heterogeneity; Hispanic Populations; Industry; Intravenous; Investigation; Iron; Ischemic Stroke; Kidney Diseases; Kidney Failure; Kidney Transplantation; Medicare; Methods; Modification; Monitor; Myocardial Infarction; Nephrology; Newly Diagnosed; Observational Study; Oral; Outcome; Outcome Study; Patient-Focused Outcomes; Patients; Pattern; Persons; Pharmaceutical Preparations; Pharmacoepidemiology; Population; Prevention; Prevention strategy; Randomized; Randomized Controlled Trials; Renal dialysis; Research; Risk; Safety; Statistical Data Interpretation; Statistical Methods; Stroke; Stroke prevention; Testing; Therapeutic; Thrombin; Time; Transferrin; Transplantation; Use Effectiveness; Vitamin K; Warfarin; Work; adverse outcome; clinical practice; comparative effectiveness; comparative safety; design; effectiveness evaluation; experience; experimental study; gastrointestinal; heart rhythm; high risk; high risk population; improved; inhibitor; interest; mortality; novel drug class; novel therapeutics; older patient; patient population; pill; placebo controlled trial; safety outcomes; thrombotic; treatment group; trend

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.

项目概要/摘要 超过 150 万美国人患有晚期慢性肾病或不可逆肾病 失败需要透析或肾移植。心房颤动是最常见的心脏疾病 节律紊乱在肾病患者中尤其常见： 四分之一的不可逆性肾衰竭患者患有心房颤动。有心房疾病的人 颤动会增加血栓栓塞事件（尤其是中风）和死亡的风险。口服 抗凝（使用药物稀释血液）已被证明可以降低一般风险 没有晚期肾病的人群。虽然华法林是一种维生素 K 阻滞剂， 对此的主要治疗方法，它受到重大缺陷的损害，包括许多缺陷 与其他药物或食物的相互作用以及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，一类新的药物出现了。 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，并且可以固定剂量服用。 然而，缺乏预防缺血性中风和缺血性中风的各种策略的证据。 患有房颤的晚期肾病患者的死亡率。 拟建项目将重点对有效性和安全性进行综合评价 这些较新的 DOAC 在晚期慢性肾病患者和患有以下疾病的患者中的应用 不可逆的肾衰竭。我们将在 2 个人群中检验所有假设： a) 目标 1：医疗保险 - 被诊断患有 4 期或 5 期慢性肾病（未进行透析）的受保人；和 b) 目标 2：接受透析的不可逆性肾衰竭患者。患者将被要求 也可诊断为房颤。然后我们将比较重要的发生情况 接受华法林的人与使用其中一种 DOAC 的人之间发生的事件。学习 感兴趣的结果包括中风、心脏病、出血事件和死亡。在目标 3 中，我们 将识别新诊断出患有房颤的透析患者，这些患者以前曾患有房颤 未服用任何口服抗凝剂的患者之间的相同结果进行比较 对其他类似的患者开始 DOAC 治疗，但未开始任何口服抗凝治疗。我们 将使用复杂的统计方法和分析来实现之间的公平比较 在不进行随机实验的情况下尽可能多地进行治疗组。我们的 研究结果将填补重要的证据空白，并有可能立即影响 临床实践，从而改善患者的治疗效果。