• Cardiology Clinical Trials
• Renal Disease
• Interventional Techniques & Devices
• Hypertension & Kidney Disease
• Hypertensive Disease
• Renal Artery Obstruction

• Cardiology Clinical Trials
• Renal Disease
• Interventional Techniques & Devices
• Hypertension & Kidney Disease
• Hypertensive Disease
• Cardiology & Cardiovascular Medicine
• Renal Artery Obstruction

Atherosclerotic renal artery stenosis (RAS) becomes more prevalent with age and is often incidentally diagnosed, but existing data is unclear as to whether revascularization of RAS prevents major adverse cardiovascular (CV) events. The objective of the Cardiovascular Outcomes in Renal Atherosclerotic Lesions study [CORAL] was to determine whether renal artery stenting, in combination with optimal medical therapy, could reduce the incidence of major clinical events in patients with both atherosclerotic RAS and a potentially related clinical syndrome—either systolic hypertension or chronic kidney disease (CKD).

Christopher J. Cooper, MD, University of Toledo, Toledo, Ohio, USA, gave an overview of the results from the CORAL trial. CORAL was an international, open-label, randomized, multicenter, controlled clinical trial sponsored by the National Heart, Lung and Blood Institute [Cooper CJ et al. N Engl J Med 2013]. Patients were eligible for the study if they had atherosclerotic RAS (defined as angiographic evidence of ≥60% and <100% stenosis, renal artery duplex with systolic velocity of >300 cm/sec, or evidence of RAS on core lab approved magnetic resonance angiography/computed tomography angiography) as well as either hypertension requiring ≥2 antihypertensive medications or Stage 3 or greater CKD. All participants were provided antiplatelet therapy, candesartan plus/minus hydrochlorothiazide, and atorvastatin plus amlodipine. Participants were randomized 1:1 to medical therapy alone or in combination with renal artery stenting. The primary endpoint was a composite of CV or renal death, stroke, myocardial infarction (MI), hospitalization for heart failure, progressive renal insufficiency, or a need for permanent renal replacement therapy.

A total of 947 patients were randomized, 467 to renal stenting plus medical therapy (stent group) and 480 to medical therapy alone. In the stent group, 434 (94.6%) received a stent, and 12 patients (2.5%) in the medical therapy group crossed over to the stent group before the end of the study. The study population was evenly split between men and women, with a mean age of 69 years. The majority of patients (91%) were white, 34% had diabetes, and 13% had heart failure. In the stent group, stenosis was reduced to 16% (p<0.001) with approximately one stent per vessel. None of the participants needed dialysis within 30 days post randomization, and only one patient in the stent group (0.2%) started dialysis between 30 and 90 days after randomization. The median follow up was 43 months.

Overall there was no difference in the rate of the primary endpoint at 3 years between patients treated with stenting plus optimal medical therapy versus optimal medical therapy alone (35.1% vs 35.8%; HR, 0.94; 95% CI, 0.76 to 1.17; p=0.58). Findings were generally consistent across subgroups (Table 1) and for the individual primary endpoint elements as well as secondary endpoints. The stent group did have a significant reduction in systolic blood pressure at 3 years (∼2 mm Hg; p=0.03). “Stenting, when added to medical therapy, did not reduce the rate of clinical events,” summarized Dr. Cooper.

The discussant, Dr. Zeller of Universitäts-Herzzentrum Freiburg - Bad Krozingen, Bad Krozingen, Germany, noted several characteristics of the study that might limit its generalizability. First, the anatomic inclusion criteria for RAS were more consistent with moderate to severe stenosis and did not require proof that the lesion was hemodynamically significant. He showed that the degree of stenosis included in the study when reviewed by a core lab was ∼67% in each group, consistent with moderate stenosis. Secondly, he pointed out that these results should not be applied to other etiologies of RAS including arteritis or firbromuscular dysplasia. He concluded by stating that CORAL showed that renal artery stenting for moderate RAS lesions does not improve clinical outcomes but that the impact of treatment for patients with severe lesions could not be definitively concluded through the CORAL results.

• © 2013 MD Conference Express®