DALLAS—Renal artery stenting confers no additional benefit beyond optimal drug therapy for preventing adverse renal and cardiovascular events in patients with renal artery stenosis and chronic kidney disease (CKD) or hypertension, according to data from a randomized clinical trial of more than 900 patients.
The findings from the National Institutes of Health-supported CORAL (Cardiovascular Outcomes in Renal Atherosclerotic Lesions) study, presented by Christopher J. Cooper, MD, at the American Heart Association’s Scientific Sessions 2013, support those from other recent clinical trials of renal artery stenting and should prompt further restriction of its use.
After initial enthusiasm in the late 1990s and early 2000s for renal artery stenting for patients with atherosclerotic renal artery stenosis or hypertension, use of the intervention had already been declining based on studies published prior to CORAL, said Mark Creager, MD, Director of the Vascular Center at Brigham and Women’s Hospital in Boston.
“I hope [the CORAL study] does alter how people take care of patients. I think what it shows is, that with good medical therapy, the majority of patients can be managed without the need for a stent,” said Dr. Cooper, Chairman of the Department of Medicine at the University of Toledo in Ohio.
The 947 patients enrolled in the open-label CORAL study had an atherosclerotic renal artery stenosis (greater than 60% occlusion but less than 100%) and either hypertension that required two or more antihypertensive drugs to control or stage 3 or higher CKD. Investigators randomly assigned patients to receive medical therapy with candesartan—with or without a thiazide diuretic—and amlodipine/atorvastatin, or the same medical therapy plus renal artery stenting.
Mean systolic blood pressure (SBP) on study entry was 150 mm Hg, the mean estimated glomerular filtration rate was 58 mL/min/1.73 m2, and the mean percent diameter stenosis was 67%. In addition, 34% of patients had diabetes and 13% had congestive heart failure.
The mean percent diameter stenosis in the stented group was reduced to 16% and the mean SBP was reduced by 2.3 mm Hg more in the intervention patients compared with the group randomized to medical therapy alone. Procedural complications were infrequent, with dissection being the most common (2.2%).
Over a median follow-up of 43 months, the rates of a composite endpoint of cardiovascular or renal death, stroke, myocardial infarction, hospitalization for heart failure, progressive renal insufficiency, or need for renal replacement therapy occurred in 35.1% of stented patients compared with 35.8% of those on medical therapy alone, a difference that was not statistically significant.
Commenting on the new study, Harold Duerman, MD, Professor of Medicine at the University of Vermont in Burlington, and a CORAL investigator, observed: “This is a trial that complements other trials like ASTRAL [Angioplasty and Stent for Renal Artery Lesions]. We have already seen a reduction in renal artery stenting over the past five years. [CORAL] should have an ongoing effect on a trend that’s already happening in terms of renal revascularization.”
Philippe Gabriel Steg, MD, Professor of Cardiology at the Université Paris-Diderot, noted: “Three times is a charm. This is the third negative trial and the largest and probably the one that has the methodology that is the soundest of the three. It addressed all of the criticism that has been leveled in the prior trials. Basically to me, it nails the coffin.”