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.


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