A Randomized Trial of Fistula vs. Graft Arteriovenous Vascular Access in Older Adults with End-Stage Kidney Disease on Hemodialysis: The AV ACCESS Trial

摘要 终末期肾病是一种衰老疾病，由多种共存的健康状况加剧。近 50%开始慢性血液透析治疗终末期肾病的患者年龄≥ 65岁。 使用中心静脉导管进行血液透析通路的患者通常会接受外科手术放置 动静脉通路-瘘管或移植物-以降低感染、血管并发症和 与导管使用相关的死亡。动静脉内瘘一直被认为是一线血管通路 选择，与移植作为第二好。然而，最近的一些研究表明，移植可能是一个更好的 老年人血液透析通路中，在没有证据的情况下， 临床试验，这些研究不能融入实践。我们进行了第一个试点试验（N = 46）， 显示了招募和随机化老年人手术瘘管或移植物放置的可行性，89% (20 79%（19/24）的移植物放置患者接受了 指定干预。在此成功试点的基础上，我们提出了一个务实的多中心随机临床试验， 在262名65岁及以上的成人中进行的试验，通过导管接受血液透析。无偏见，比较 不同入路策略之间的临床结局和患者观点的表征将促进 第一次，以证据为基础的血管通路护理。我们的长期目标是优化临床 基于客观的、特定年龄的数据做出决策，同时结合护理目标和患者偏好， 血管通路类型。本提案的目的是描述血管通路对疾病特异性 和患者报告的结果，在6个国家的研究中心，使用随机干预， 在患有终末期肾病和并存的冠状动脉疾病的老年人中进行移植物放置， 外周动脉疾病和/或糖尿病。最重要的假设是， 该策略将产生更多的无透析导管天数、更低的成本和更好的患者满意度。我们的具体 目的是确定瘘管与移植血管通路策略对无导管透析率的影响 天数和入路相关感染和死亡（主要目的），与血管入路护理相关的费用 （次要目的）和患者报告的对入路相关结局的满意度（第三目的）。我们还将 研究术前客观和主观身体功能指标之间的关系， 瘘或移植物成熟失败（探索性目的）。这项试验的结果可能会改变临床实践 通过提供高质量的证据来指导老年人透析血管通路的常见临床决策， 成年人-不断增长的人口，其护理复杂且昂贵。

ABSTRACT End-stage kidney disease is a disease of aging, exacerbated by multiple coexisting health conditions. Nearly 50% of patients initiating chronic hemodialysis for treatment of end-stage kidney disease are 65 years or older. Patients who use central venous catheters for hemodialysis access typically undergo surgical placement of an arteriovenous access—either a fistula or a graft—to reduce the risks of infection, vascular complications and death associated with catheter use. Arteriovenous fistulas have long been considered first-line vascular access option, with grafts as second best. However, several recent studies suggest that grafts may be a better strategy than fistulas for hemodialysis access in older adults. Without evidence from well-powered randomized clinical trials, these studies cannot be integrated into practice. We conducted the first pilot trial (N=46) that revealed the feasibility of enrolling and randomizing older adults to surgical fistula or graft placement, with 89% (20 of 22) of those assigned to fistula and 79% (19 of 24) of those assigned to graft placement undergoing the assigned intervention. Building on this successful pilot, we propose a pragmatic multicenter randomized clinical trial in 262 adults, 65 years of age and older, receiving hemodialysis via catheters. Unbiased, comparative characterization of clinical outcomes and patient views between alternative access strategies will advance the field, for the first time, to evidence-based vascular access care. Our long-term goals are to optimize clinical decisions based on objective, age-specific data while incorporating goals of care and patient preference for vascular access type. The objective of this proposal is to delineate vascular access effects on disease-specific and patient-reported outcomes, using a randomized intervention, at 6 national sites, of surgical fistula versus graft placement in older adults who have end-stage kidney disease and coexisting coronary artery disease, peripheral arterial disease, and/or diabetes mellitus. The overarching hypothesis is that graft placement strategy will yield more dialysis catheter-free days, lower cost, and better patient satisfaction. Our Specific Aims will determine the effects of fistula versus graft vascular access strategy on rates of catheter-free dialysis days and access-related infections and death (Primary Aim), costs associated with vascular access care (Secondary Aim), and patient-reported satisfaction with access-related outcomes (Tertiary Aim). We will also investigate the relationship between preoperative objective and subjective measures of physical function and failure of fistula or graft maturation (Exploratory Aim). Results from this trial could transform the clinical practice by providing high-quality evidence to guide common clinical decisions on dialysis vascular access in older adults—a growing population whose care is complex and costly.