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Cardiovascular Outcomes in Renal Atherosclerotic Lesions - CORAL
Description:
The goal of the trial was to evaluate treatment with renal artery stenting compared with medical therapy among patients with atherosclerotic renal artery stenosis.
Contribution to the Literature: The CORAL trial failed to demonstrate that renal artery stenting will improve cardiovascular (CV) outcomes.
Study Design
- Randomized
- Parallel
Patient Populations:
- Patients with renal artery stenosis (>80% angiographic stenosis or 60%-80% stenosis with >20 mm Hg pressure gradient) and systolic hypertension (>155 mm Hg despite use of two or more antihypertensive medications) or chronic kidney disease (estimated glomerular filtration rate <60 ml/min/1.73 m2)
Number of screened applicants: 5,322 patients
Number of enrollees: 947 patients
Duration of follow-up: median 43 months
Mean patient age: 69 years
Percentage female: 49%
Exclusions:
- Stenosis due to fibromuscular dysplasia
- Chronic kidney disease due to a cause other than ischemia
- Serum creatinine >4 mg/dl
- Kidney length <7 cm
- Renal stenosis that could not be treated with a single stent
Primary Endpoints:
- Death from CV or renal causes, MI, stroke, hospitalization for heart failure, progressive renal insufficiency, or need for dialysis
Secondary Endpoints:
- Individual components of the primary outcome
Drug/Procedures Used:
Patients with atherosclerotic renal artery stenosis and systolic hypertension or chronic kidney disease were randomized to renal artery stenting (n = 467) versus medical therapy (n = 480).
Stenting was performed with the Palmaz Genesis stent with pre-dilatation according to operator discretion. An embolic protection device was also used according to operator discretion.
Concomitant Medications:
The following medications were mandated in both study groups to achieve target blood pressure: the angiotensin-receptor blocker candesartan and the combination agent amlodipine–atorvastatin.
Target blood pressure was <140/90 mm Hg without pre-existing conditions or <130/85 mm Hg with diabetes or chronic kidney disease.
Principal Findings:
Overall, 947 patients were randomized. The mean age was 69 years, 49% were women, mean body mass index was 28 kg/m2, mean systolic blood pressure was 149 mm Hg, 32% had diabetes, 27% had prior myocardial infarction (MI), and the percent stenosis assessed by core laboratory was 67%.
The primary composite outcome of death from CV or renal causes, MI, stroke, hospitalization for heart failure, progressive renal insufficiency, or need for dialysis occurred in 35.1% of the stent group versus 35.8% of the medical group (p = 0.58). The result was similar among prespecified subgroups, including lesion severity, pressure gradient, or baseline blood pressure.
- Death from CV or renal causes: 4.4% vs. 4.2%, respectively, for stent vs. medical groups
- Stroke: 2.6% vs. 3.4%, respectively
- MI: 6.5% vs. 5.7%, respectively
- Hospitalization for heart failure: 5.9% vs. 5.5%, respectively
- Progressive renal insufficiency: 14.8% vs. 16.3%, respectively
- Dialysis: 0.9% vs. 0.6%, respectively
At baseline, the mean number of antihypertensive medications was 2.1/patient in the stent group, which increased to 3.3/patient and 2.1/patient in the medical group, which increased to 3.5/patient (p = 0.24).
During the course of the study, systolic blood pressure was 2.3 mm Hg lower in the stent compared with the medical group (p = 0.03).
Interpretation:
Among patients with renal artery stenosis (with hypertension or renal insufficiency), renal artery stenting was not beneficial. Findings were similar in multiple prespecified subgroups. This treatment was hypothesized to improve a composite of CV outcomes. However, on a background of effective medical therapy, renal artery stenting did not slow the progression of renal insufficiency, nor did it reduce important CV outcomes. This negative result was despite a modestly lower achieved blood pressure in the stent group. These findings complement the ASTRAL and STAR trials, which were unable to document a benefit on kidney function from renal artery stenting.
References:
Murphy TP, Cooper CJ, Matsumoto AH, et al. Renal Artery Stent Outcomes: Effect of Baseline Blood Pressure, Stenosis Severity, and Translesion Pressure Gradient. J Am Coll Cardiol 2015;66:2487-94.
Cooper CJ, Murphy TP, Cutlip DE, et al., on behalf of the CORAL Investigators. Stenting and Medical Therapy for Atherosclerotic Renal-Artery Stenosis. N Engl J Med 2014;370:13-22.
Presented by Dr. Christopher Cooper at the American Heart Association Scientific Sessions, Dallas, TX, November 18, 2013.
Keywords: Myocardial Infarction, Stroke, Dilatation, Blood Pressure, Constriction, Pathologic, Stents, Renal Dialysis, Embolic Protection Devices, Body Mass Index, Renal Artery Obstruction, Heart Failure, Glomerular Filtration Rate, Hospitalization, Hypertension, Diabetes Mellitus, Renal Insufficiency, Chronic
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