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 终末期肾病是一种老年性疾病，多种健康状况并存会加剧这种疾病。差一点 为治疗终末期肾病而启动慢性血液透析的患者中，有50%年龄在65岁或以上。 使用中心静脉导管进行血液透析通路的患者通常会接受手术放置 动静脉通路--无论是瘘管还是移植物--以降低感染、血管并发症和 与使用导尿管有关的死亡。动静脉瘘长期以来一直被认为是一线血管通路 选择，移植物是第二好的。然而，最近的几项研究表明，移植可能是一种更好的 老年人血液透析途径中使用瘘管的策略。没有来自有力的随机调查的证据 临床试验，这些研究不能整合到实践中。我们进行了第一次试点试验(N=46)， 揭示了招募和随机选择老年人进行外科瘘管或移植物植入的可行性，89%的人 (20/22)瘘管者和79%(19/24)的移植物植入者接受 指定的干预措施。在这一成功试验的基础上，我们提出了一个务实的多中心随机临床试验。 对262名65岁及以上的成年人进行了试验，他们通过导管接受血液透析。不偏不倚的，比较的 在不同的获取策略之间表征临床结果和患者意见将促进 菲尔德，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 决策基于客观的、特定于年龄的数据，同时纳入护理目标和患者对 血管通路类型。这项建议的目的是描绘血管通路对特定疾病的影响 和患者报告的结果，使用随机干预，在6个国家地点，手术瘘与 终末期肾病合并冠状动脉疾病的老年人的移植物植入， 外周动脉疾病和/或糖尿病。最重要的假设是移植物的放置 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。我们的特定 AIMS将决定瘘管与移植物血管通路策略对无导管透析率的影响 天数和通道相关感染和死亡(主要目标)，与血管通道护理相关的成本 (二级目标)，以及患者报告的对获取相关结果的满意度(第三目标)。我们还将 术前体能主观与客观功能指标的关系探讨 瘘管或移植物成熟失败(探查目标)。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关于透析血管通路的常见临床决策 成年人--一个不断增长的人口，他们的护理工作复杂而昂贵。

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.