CORAL: Renal Artery Stenting in Preventing CV and Renal Events
Renal artery stenting, as compared to medical therapy, does not reduce the incidence of cardiovascular or renal events among patients with atherosclerotic renal artery stenosis, according to results of the CORAL trial presented Nov. 18 as part of AHA 2013, and published simultaneously in the New England Journal of Medicine.
The CORAL (Cardiovascular Outcomes in Renal Atherosclerotic Lesion) study randomized 947 patients with atherosclerotic renal artery stenosis and hypertension or chronic kidney disease to renal artery stenting plus medical therapy or medical therapy alone. Medical therapy, unless contraindicated, included candesartan with or without hydrochlorothiazide and the combination agent amlodipine-atorvastatin.
Over the course of a median 43 months of follow-up, 35.1 percent of patients who underwent stent implantation and 35.8 percent of patients who received medical therapy alone reached the primary endpoint of a composite of adverse cardiovascular and renal events that included death from cardiovascular or renal causes, myocardial infarction, stroke, hospitalization for congestive heart failure, progressive renal insufficiency or the need for renal-replacement therapy. The difference did not reach statistical significance (p=0.58). No statistically significant differences in the individual components of the composite endpoint or all-cause mortality were observed. Stenting was associated with a modest improvement in systolic blood pressure during follow-up (-2.3 mm Hg; 95 percent CI, -4.4 to -0.2, p=0.03).
"Stenting of atherosclerotic renal stenosis has been reasonable, despite several negative studies, because other studies suggested it might lower blood pressure and stabilize kidney function," said Christopher J. Cooper, MD, FACC, the study's lead author and professor and chairman of the Department of Medicine at the University of Toledo, Ohio. "But in our study, opening narrowed kidney arteries with stents provided no additional benefit when added to medications that lower blood pressure, control cholesterol levels and block substances involved in blood clotting."
In an editorial comment, John A. Bittl, MD, FACC, Munroe Regional Medical Center, Ocala, FL, wrote, "The CORAL trial is a definitive test of the usefulness of renal artery stents for moderately severe atherosclerotic disease. The trial results send a clear message to patients and referring physicians ... patients in everyday practice who have moderately severe atherosclerotic renovascular disease and either hypertension or stage 3 chronic kidney disease should receive medical therapy to control blood pressure and prevent the progression of atherosclerosis but should not be corralled into getting a renal artery stent."
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