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Previous small studies have failed to find any benefit associated with renal-artery stenting, but the trials have been small and were not powered for clinical outcomes. Now, the CORAL (Cardiovascular Outcomes in Renal Atherosclerotic Lesions) trial, presented at the American Heart Association meeting and published simultaneously in the New England Journal of Medicine, offers strong and persuasive evidence that renal-artery stenting is not beneficial.

A total of 947 patients with renal-artery stenosis and either systolic hypertension, despite taking two or more antihypertensive agents, or chronic kidney disease were randomized to medical therapy plus stenting or medical therapy alone. There were no significant differences after 43 months in the primary composite endpoint of cardiovascular and renal events (death from cardiovascular or renal causes, MI, stroke, hospitalization for congestive heart failure, progressive renal insufficiency, or the need for renal-replacement therapy):

• 35.1% for  patients in the stent group versus 35.8% for patients in the medical-treatment group (HR 0.94, CI 0.76-1.17, p=0.58)

There were also no significant differences in the individual components of the endpoint or in any of the major subgroups. There was a small but significant difference in systolic blood pressure, favoring the stent group (-2.3 mm Hg, CI -4.4 to -0.2, p=0.03).

“Beyond A Reasonable Doubt”

In an accompanying editorial, John Bittl writes that the trial “establishes beyond a reasonable doubt that renal-artery stenting is futile for the target population enrolled in the study. Patients who have atherosclerotic disease with a mean renal-artery stenosis of 73%, as assessed visually on angiography, in addition to hypertension while receiving two or more antihypertensive drugs or stage 3 chronic kidney disease, should not undergo renal-artery stenting, because the only tangible consequence is the procedure-related risk of bleeding or vascular complications.”

Bittle notes that although CORAL included patients with stenoses as low as 60%, the results were no different in the subgroup of patients with stenoses of at least 80%. This finding “suggests that a benefit of renal-artery stenting even for patients with fairly severe disease is difficult to predict.”

CardioExchange’s Rick Lange and David Hillis ask whether CORAL should lead clinicians to stop screening for renal artery stenosis. Join the conversation.