CABG and PCI for the Treatment of CAD in Individuals with CKD

描述（由申请人提供）：慢性肾脏疾病（CKD）是一种常见且昂贵的疾病，影响超过10%的美国人口。它与患心血管疾病和死于心血管疾病的高风险有关，在其晚期与每年接近10%的心血管死亡率有关。尽管存在高风险且CKD人群规模不断增加，但关于中度以上肾功能损害的心血管疾病治疗的信息仍然很少。考虑到CKD患者和非CKD患者在潜在的全因死亡率、心血管病理生理和心血管危险因素方面的主要差异，在严重CKD的情况下，普通人群中使用的标准心血管护理方法可能需要修改。因此，治疗CKD患者心血管疾病的最佳方法仍然不确定，需要对CKD患者心血管治疗的风险和益处进行分析，以提高这一日益增长的高危人群的利用率和优化结果。在冠状动脉血管重建术治疗中尤其如此。冠状动脉旁路移植术（CABG）和经皮冠状动脉介入治疗（PCI）被广泛应用于CKD患者，但与这些治疗相关的手术风险在CKD患者中很高，并且它们在这种情况下的长期疗效尚不清楚。我们提出了一系列的分析，使用一个独特的数据集的个体患者参加随机试验，比较CABG和PCI，这将创建一个证据基础，将允许更优化的使用CABG和PCI的CKD患者。将评估CABG与PCI在预防CKD患者死亡、主要心血管事件和重复血运重建方面的相对疗效，并确定CABG和PCI成功的预测因素以及每种手术不良结果的危险因素。为了便于这些分析的汇总，研究人员将收集比较CABG和PCI的随机临床试验的患者水平数据，并将其整理成一个独特的统一数据库。该数据集将用于执行关键分析，提供所需的基本信息：1)允许基于证据的CKD患者CABG和PCI的最佳使用；2)允许基于相关患者特征和危险因素对CABG和PCI的选择进行个性化决策；3)提供关于发病率、风险、结果和成本的重要数据基础，在此基础上可以建立未来的临床试验和成本效益研究。

DESCRIPTION (provided by applicant): Chronic kidney disease (CKD) is a common and costly condition affecting more than 10% of the U.S. population. It is associated with a high risk of developing and dying from cardiovascular disease and in its advanced stages is associated with cardiovascular mortality rates approaching 10% annually. Despite the high risk and the increasing size of the CKD population quality information on the treatment of cardiovascular disease in the setting of at least moderate renal impairment remains sparse. Given the major differences in underlying all-cause mortality rates, cardiovascular pathophysiology and cardiovascular risk factors in individuals with and without CKD, standard approaches to cardiovascular care used in the general population are likely to need modification in the setting of significant CKD. The best approach to the treatment of cardiovascular disease in individuals with CKD therefore remains uncertain, and analysis of the risk and benefits of cardiovascular therapies in patients with CKD is needed in order to improve utilization and optimize outcomes in this growing high-risk population. This is particularly true in the case of coronary revascularization therapies. Both coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) are widely used in patients with CKD, but procedural risks associated with these therapies are high in patients with CKD and their long-term efficacy in this setting is poorly understood. We propose a series of analyses using a unique data-set of individual patients enrolled in randomized trials comparing CABG and PCI which will create an evidence base that will allow for more optimal use of CABG and PCI in patients with CKD. The relative efficacy of CABG compared with PCI for preventing death, major cardiovascular events and repeat revascularization in patients with CKD will be assessed, and predictors of success with CABG and PCI and risk factors for adverse outcomes with each procedure will be identified. To facilitate these analyses aggregated, patient-level data from randomized clinical trials comparing CABG and PCI will be collected, cleaned and assembled into a unique, unified database by the investigators This data set will be used to perform crucial analyses that will provide the fundamental information needed to: 1) allow for evidence-based, optimal use of CABG and PCI in patients with CKD; 2) permit individualized decision-making regarding the choice between CABG and PCI on the basis of pertinent patient characteristics and risk factors; and 3) provide a crucial foundation of data on incidence, risks, outcomes and costs upon which future clinical trials and cost- effectiveness studies can be built. PUBLIC HEALTH RELEVANCE: Project Narrative: Chronic kidney disease (CKD) is a common condition affecting more than 10% of the U.S. population, associated with high risks of cardiovascular death and accounting for more than 10% of Medicare funding. Nevertheless, quality information on the treatment of cardiovascular disease in patients with CKD is sparse. The current application proposes analyses designed to lead to more efficient use of health care resources and better cardiovascular and overall outcomes in this growing, and high-risk population.