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。它与发展和死于心血管疾病的高风险相关，并且在其晚期阶段与每年接近10%的心血管死亡率相关。尽管CKD人群的高风险和规模不断增加，但关于在至少中度肾损害的情况下治疗心血管疾病的质量信息仍然很少。考虑到CKD患者和非CKD患者的基础全因死亡率、心血管病理生理学和心血管风险因素存在重大差异，在显著CKD的情况下，可能需要修改普通人群中使用的心血管护理标准方法。因此，治疗CKD患者心血管疾病的最佳方法仍不确定，需要分析CKD患者心血管治疗的风险和获益，以提高这一不断增长的高风险人群的利用率并优化结局。在冠状动脉血运重建治疗的情况下尤其如此。冠状动脉旁路移植术（CABG）和经皮冠状动脉介入治疗（PCI）均广泛用于CKD患者，但CKD患者与这些治疗相关的手术风险较高，且其在这种情况下的长期疗效尚不清楚。我们提出了一系列分析，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，将允许更优化使用CABG和PCI的CKD患者。将评估CABG与PCI相比在预防CKD患者死亡、重大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局的风险因素。为了促进这些分析，研究者将收集、清理并将来自比较CABG和PCI的随机临床试验的患者水平数据汇总到一个独特的统一数据库中。该数据集将用于进行关键分析，该分析将提供所需的基本信息：1）允许在CKD患者中基于证据的最佳使用CABG和PCI; 2）允许基于相关患者特征和风险因素做出关于CABG和PCI之间的选择的个体化决策;以及3）提供关于发生率、风险、结果和成本的关键数据基础，在此基础上可以建立未来的临床试验和成本效益研究。 公共卫生相关性： 项目叙述：慢性肾脏疾病（CKD）是一种常见疾病，影响超过10%的美国人口，与心血管死亡的高风险相关，占医疗保险资金的10%以上。然而，关于CKD患者心血管疾病治疗的质量信息很少。目前的应用程序提出了分析，旨在导致更有效地利用卫生保健资源和更好的心血管和整体结果，在这个不断增长的，高风险的人群。

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.