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

描述(申请人提供)：慢性肾脏病(CKD)是一种常见且代价高昂的疾病，影响着超过10%的美国人口。它与发展和死于心血管疾病的高风险有关，在晚期与每年接近10%的心血管死亡率有关。尽管慢性肾脏病的风险很高，而且人群的规模越来越大，但在至少中度肾损害的情况下，关于心血管疾病治疗的高质量信息仍然很少。鉴于慢性肾脏病患者和非慢性肾脏病患者潜在的全因死亡率、心血管病理生理学和心血管危险因素的主要差异，一般人群中使用的心血管护理标准方法可能需要在重大慢性肾脏病的环境中进行修改。因此，治疗慢性肾脏病患者心血管疾病的最佳方法仍然不确定，需要对慢性肾脏病患者心血管治疗的风险和好处进行分析，以便在不断增长的高危人群中提高利用率并优化结果。在冠状动脉血运重建治疗中尤其如此。冠状动脉旁路移植术(CABG)和经皮冠状动脉介入治疗(PCI)都被广泛应用于CKD患者，但这些治疗方法对CKD患者的操作风险很高，而且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，使用的是随机试验中登记的单个患者的独特数据集，比较了CABG和PCI，这将创建一个证据基础，允许在CKD患者中更优化地使用CABG和PCI。将评估冠状动脉旁路移植术与经皮冠状动脉旁路移植术在预防CKD患者死亡、主要心血管事件和重复血管重建方面的相对有效性，并确定冠脉搭桥术和经皮冠状动脉搭桥术成功的预测因素以及每种手术不良结果的风险因素。为了促进这些分析，研究人员将收集、清理和汇编来自CABG和PCI的随机临床试验的患者层面的数据，这些数据集将被用于执行关键分析，这些分析将提供所需的基本信息：1)使CKD患者能够以循证的方式最佳地使用CABG和PCI；2)根据相关的患者特征和风险因素，对CABG和PCI之间的选择进行个性化决策；3)为未来的临床试验和成本效益研究提供重要的发病率、风险、结果和成本方面的数据基础。 公共卫生相关性： 项目简介：慢性肾脏疾病(CKD)是一种常见疾病，影响着超过10%的美国人口，与心血管死亡的高风险相关，占联邦医疗保险资金的10%以上。然而，关于慢性肾脏病患者心血管疾病治疗的高质量信息仍然很稀少。目前的申请提出了旨在导致更有效地使用卫生保健资源以及在不断增长的高危人群中改善心血管和整体结果的分析。

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.