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.
Findings from this study are expected to inform public health discourse and optimize the delivery of care for CAD in the setting of CKD. These findings are expected to improve survival and health related quality of life and to reduce costs of care in a growing, high-risk population poorly served by the existing evidence base. .
