Randomized clinical trials have not shown an additional clinical benefit of renal artery stent placement over optimal medical therapy alone. However, studies of renal artery stent placement have not examined the relationship of albuminuria and treatment group outcomes.
The CORAL study is a prospective clinical trial of 947 participants with atherosclerotic renal artery stenosis randomized to optimal medical therapy (OMT) with or without renal artery stent which showed no treatment differences (35.8% and 35.1% event rate at mean 43 month follow-up). In a post-hoc analysis, the study population was stratified by the median baseline urine albumin/creatinine ratio (uACR)(n=826) and analyzed for the 5-year incidence of the primary endpoint (myocardial infarction, hospitalization for congestive heart failure, stroke, renal replacement therapy, progressive renal insufficiency, or cardiovascular- or kidney disease-related death), as well as for each component of the primary endpoint, and overall survival.
When baseline uACR was <= median (22.5 mg/g, n=413), renal artery stenting was associated with significantly better event-free survival from the primary composite endpoint (73% vs 59% at 5 years, p=.02), cardiovascular disease-related death (93% vs. 85%, p=<.01), progressive renal insufficiency (91% vs 77%, p=.03), and overall survival (89% vs. 76%, p=<.01), but not when baseline uACR was > median (n=413).
These data suggest that low albuminuria may indicate a potentially large subgroup of those with renal artery stenosis that could experience improved event-free and overall-survival after renal artery stent placement plus OMT compared with OMT alone. Further research is needed to confirm these preliminary observations.