Health-relatedness and Long-term Objectives: Atherosclerotic renal artery stenosis is a common problem for which there is no clear consensus on diagnosis or therapy. There likely exists a progression wherein renal ischemia leads to neuroendocdne activation, hypertension, and renal insufficiency potentially resulting in acceleration of therosclerosis, further renal dysfunction, myocardial infarction, stroke and death. The current proposal tests whether revascularization of a stenotic renal artery plus optimum medical therapy is associated with improved clinical outcomes when compared with optimum medical therapy alone.
Specific Aims, Design and Methods: Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) is a randomized clinical trial that will contrast the effect of optimum medical therapy alone to stenting with optimum medical therapy, on a composite cardiovascular and renal endpoint: cardiovascular or renal death, myocardial infarction, hospitalization for congestive heart failure, stroke, doubling of serum creatinine level, and need for renal replacement therapy. This endpoint will be adjudicated by a clinical events committee masked to treatment assignment. The secondary endpoints 1) evaluate the mechanisms linked to clinical events;2) describe differential effectiveness in critical end-organs;3) determine the value of stenting from the patient and the health policy perspectives, measured as quality of life and cost effectiveness;and 4) evaluate for clinically relevant differences in treatment effectiveness within the primary endpoint. The primary entry criteria are an atherosclerotic renal stenosis >=60% with a 20 mmHg systolic pressure gradient and systolic hypertension >155 mmHg on 2 or more anti-hypertensive medications. A slight predominance of women is expected, and high priority will be placed on minority recruitment. Approximately 2200 patients will undergo a baseline evaluation with randomization occurring in 1080. The study has 90% power to detect a 28% reduction in primary endpoint hazard rate. This R01, from the economics and quality of life core laboratory, describes the additional data collection and analyses that are proposed to determine the benefits of renal artery stenting on health-related quality of life and the cost-effectiveness of renal artery stenting in terms of a standard metric-cost per quality-adjusted year of life gained.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HL072736-07
Application #
8335419
Study Section
Clinical Trials Review Committee (CLTR)
Program Officer
Reid, Diane M
Project Start
2004-04-01
Project End
2014-03-31
Budget Start
2012-06-01
Budget End
2013-03-31
Support Year
7
Fiscal Year
2012
Total Cost
$232,175
Indirect Cost
$72,054
Name
Saint Luke's Hospital
Department
Type
DUNS #
073039653
City
Kansas City
State
MO
Country
United States
Zip Code
64111
Murphy, Timothy P; Cooper, Christopher J; Cutlip, Donald E et al. (2014) Roll-in experience from the Cardiovascular Outcomes with Renal Atherosclerotic Lesions (CORAL) study. J Vasc Interv Radiol 25:511-20
Cooper, Christopher J; Murphy, Timothy P; Cutlip, Donald E et al. (2014) Stenting and medical therapy for atherosclerotic renal-artery stenosis. N Engl J Med 370:13-22
Evans, Kaleigh L; Tuttle, Katherine R; Folt, David A et al. (2014) Use of renin-angiotensin inhibitors in people with renal artery stenosis. Clin J Am Soc Nephrol 9:1199-206
Hendricks, Nicholas J; Matsumoto, Alan H; Angle, John F et al. (2014) Is fibromuscular dysplasia underdiagnosed? A comparison of the prevalence of FMD seen in CORAL trial participants versus a single institution population of renal donor candidates. Vasc Med 19:363-7