Stenting Added to Medical Therapy for Atherosclerotic Renal Artery Stenosis

Dallas—Stenting added to medical therapy did not reduce the rate of major cardiovascular and renal events compared with medical therapy alone in patients with atherosclerotic renal artery stenosis and hypertension or chronic kidney disease, according to an open-label, randomized, international, multicenter, controlled trial.

At 3 years, the event rate was 35.8% in the medical therapy group and 35.1% in the stent plus medical therapy group (hazard ratio [HR], 0.94; 95% confidence interval, 0.76-1.17; P=.58). The composite of major cardiovascular or renal events included cardiovascular or renal death, stroke, myocardial infarction (MI), heart failure hospitalization, progressive renal insufficiency, and permanent renal replacement therapy. There were no statistically significant differences in the groups for any of the components of composite primary end point.

Christopher Cooper, MD, lead author of the study, presented the results at the AHA Scientific Sessions during a late-breaking abstract session. The findings were also published in New England Journal of Medicine [2014;370(1):13-22].

Pfizer, Inc., Cordis Corp., and the National Heart, Lung, and Blood Institute of the National Institutes of Health funded the study. AstraZeneca and Pfizer provided the drugs used in the trial.

Dr. Cooper said atherosclerotic renal artery stenosis is a common problem for older patients. He added that revascularization for preventing major adverse renal and cardiovascular events is controversial even though several randomized trials have tested the procedure.

In the CORAL (Cardiovascular Outcomes in Renal Atherosclerotic Lesions) trial, patients were included if they had hypertension and took 2 or more antihypertensive medications or renal dysfunction defined as stage 3 or higher chronic kidney disease. They also were required to have atherosclerotic renal artery stenosis.

All patients received medical therapy, including blood pressure, diabetes, and lipid management, and were given free candesartan with or without hydrochlorothiazide or atorvastatin plus amlodipine. They also took antiplatelet therapy.

The authors randomized 947 patients in a 1:1 ratio to receive a stent plus medical therapy (n=467) or medical therapy alone (n=480). There were no significant differences in clinical and angiography characteristics between the groups. At baseline, the mean age was approximately 69 years, 50% of patients were male, 91% were white, 33% had diabetes, and 30% had a prior MI. The mean blood pressure at baseline was approximately 150 mmHg.

Stenting resulted in a 16% reduction in stenosis severity, and 1.04 stents were used per vessel and embolic protection devices were used in 22.8% of patients. Patients in the stent plus medical therapy group had a persistent significant reduction in systolic blood pressure compared with the medical therapy alone group (P=.03).

Stenting was also safe: 2.2% of patients had dissection, 1.2% had branch vessel occlusion, 1.2% had angiographic evidence of distal embolization, 0.2% had wire perforation, 0.2% had vessel rupture, and 0.2% had pseudoaneurysm. Within 30 days of randomization, no patient required dialysis. One patient in the stent plus medical therapy group initiated dialysis between 30 and 90 days after randomization. On the day of randomization, a person in the medical therapy only group had a stroke that resulted in death.