Optimizing Revascularization of Coronary Artery Disease in Chronic Kidney Disease

描述（由申请人提供）：慢性肾脏疾病（CKD）影响超过6%的美国人口，占医疗保健支出的很高份额。尽管CKD患者的心血管死亡风险显著高于一般人群，但他们不太可能接受冠状动脉血运重建或接受心血管疾病（CVD）的标准药物治疗。潜在挽救生命治疗的低利用率可能受到以下因素的影响：CKD中CVD的独特病理生理学，证据表明标准治疗对晚期CKD的疗效较低，以及在一般人群中确定药物治疗（MTX）、经皮冠状动脉介入治疗（PCI）和冠状动脉旁路手术（CABG）获益的临床试验中系统性排除CKD患者。这些因素引起的关于将心血管指南从普通人群外推到CKD患者护理的担忧因PCI和CABG后手术相关肾损伤的威胁而放大。血运重建可能加速肾脏疾病的进展，当导致永久性透析依赖时，尽管心绞痛缓解，但仍可能显著降低生活质量。其他并发症，如中风，其发生率可能不同后MTX，PCI和CABG，可能有类似的影响，个人治疗方案的好处。 尽管CKD人群的增长，CVD在CKD中的普遍存在，以及对一般护理标准应用的担忧，但CKD治疗的比较疗效的具体证据仍然很少，关于比较成本或整体生活质量的信息很少。这种缺乏良好数据的情况可能导致这些疗法的使用效率低下，临床结果不理想，以及对医疗保健资源造成不必要的负担。为了更好地告知患者，医生和其他利益相关者，需要更好的比较有效性数据和相关医疗保健支出的分析，以确定最大限度地提高健康收益和成本效益的战略。 迫切需要拟议的研究，以更好地为临床决策和公共卫生话语提供信息。我们建议对医疗保险数据进行独特的分析，并将马萨诸塞州PCI和CABG登记与美国肾脏数据系统联系起来。这些数据集将使设计用于解决重要问题的分析成为可能，并促进MTX、CABG和PCI在CKD中的最佳使用。将估计治疗与相关结局（如死亡、终末期肾病、卒中、心肌梗死）和医疗保健相关费用之间的相关性。利用这些数据，我们将使用决策和成本效用分析来分析质量调整生存率和增量成本效益。

DESCRIPTION (provided by applicant): Chronic kidney disease (CKD) affects > 6% of the U.S. population and accounts for a high share of health care spending. Although patients with CKD have a risk of cardiovascular mortality significantly higher than the general population, they are nevertheless less likely to undergo coronary revascularization or receive standard medical therapies for cardiovascular disease (CVD). The low utilization of potentially life-saving therapies may be influenced by the unique pathophysiology of CVD in CKD, evidence suggesting low efficacy of standard therapies in advanced CKD, and the systematic exclusion of CKD patients from clinical trials that established the benefits of medical therapy (MTX), percutaneous coronary intervention (PCI) and coronary artery bypass surgery (CABG) in the general population. Concerns raised by these factors about extrapolating cardiovascular guidelines from the general population to the care of individuals with CKD are magnified by the threat of procedure-related kidney injury following PCI and CABG. Revascularization may accelerate progression of renal disease and, when permanent dialysis dependence results, can dramatically reduce quality of life despite relief of angina. Other complications, such as stroke, whose incidence may differ after MTX, PCI and CABG, are likely to have analogous impacts on the benefits of the individual treatment options. Despite the growth in the CKD population, the ubiquity of CVD in CKD, and concerns about the application of the general standard of care, specific evidence of the comparative efficacy of therapies in CKD remains sparse, with little information on comparative costs or overall quality of life. This absence of good data likely results in the inefficient use of these therapies, suboptimal clinical outcomes, and unnecessary burdens on health care resources. To better inform patients, physicians, and other stakeholders, better comparative effectiveness data and an analysis of associated health care expenditures are needed to identify strategies which maximize health gains and cost-efficiency. The proposed studies are critically needed to better inform clinical decision-making and public health discourse. We propose a unique analysis of Medicare data and a linkage of the Massachusetts state PCI and CABG registries with the United States Renal Data System. These data sets will enable analyses designed to address important questions and facilitate optimal use of, MTX, CABG and PCI in CKD. Associations between therapy and relevant outcomes such as death, end stage renal disease, stroke, myocardial infarction, and healthcare associated costs will be estimated. Leveraging these data, we will analyze quality-adjusted survival and incremental cost-effectiveness using decision and cost-utility analytics.