Renal Stenting Fails to Improve Outcomes vs. Medical Therapy Alone in RAS Patients

The latest randomized trial to investigate the benefits of percutaneous revascularization for renal artery stenosis (RAS) finds no improvement with stenting vs. medical therapy alone across all reported endpoints at 43 months of follow-up. The only exception was a slight improvement in systolic blood pressure with stenting, according to results presented November 18, 2013, at the annual American Heart Association Scientific Sessions in Dallas, TX, and simultaneously published in the New England Journal of Medicine.

For the CORAL (Cardiovascular Outcomes in Renal Atherosclerotic Lesions) trial, researchers led by Christopher J. Cooper, MD, of the University of Toledo (Toledo, OH), looked at 947 RAS patients with either systolic hypertension while taking 2 or more antihypertensive drugs or chronic kidney disease. Patients were randomized to medical therapy with (n = 459) or without (n = 472) stenting. Medical therapy consisted of candesartan with or without hydrochlorothiazide and the combination agent amlodipine-atorvastatin. The Palmaz Genesis stent (Cordis, Miami, FL) was used in the stenting group.

After a median follow-up of 43 months, there was no difference between groups in the primary composite endpoint of death from cardiovascular or renal causes, stroke, MI, hospitalization for CHF, progressive renal insufficiency, or permanent renal replacement therapy. Nor were there any differences in the individual component endpoints (table 1).

Table 1. CORAL Clinical Endpoints at 43 Months

While systolic BP was lowered in both the stenting plus medical therapy group and the medical therapy alone group, it was modestly lower over the course of follow-up in the stent group (-2.3 mm Hg; 95% CI -4.4 to -0.2 mm Hg; P = 0.03). However, this reduction did not translate into any lowering of clinical events.

The primary and component endpoints remained unchanged by treatment modality across multiple subgroups defined by sex, race, presence of diabetes, or presence of global ischemia.

Three Strikes for Renal Stenting?

After ASTRAL and STAR, CORAL represents the third major randomized trial to fail to show any improvements in clinical outcomes from the addition of renal stenting in RAS patients on medication therapy.

Nevertheless, “[r]enal-artery stenting remains a common procedure in current clinical practice,” Dr. Cooper and colleagues note. But CORAL should leave no doubt that “medical therapy without stenting is the preferred management strategy for the majority of people with atherosclerotic renal-artery stenosis,” the authors stress.

In an accompanying editorial, John A. Bittl, MD, of the Munroe Regional Medical Center (Ocala, FL), calls CORAL “a definitive test of the usefulness of renal-artery stents for moderately severe atherosclerotic disease,” adding that “The trial results send a clear message to patients and referring physicians [that] patients in everyday practice who have moderately severe atherosclerotic renovascular disease and either hypertension or stage 3 chronic kidney disease should receive medical therapy to control blood pressure and prevent the progression of atherosclerosis but should not be corralled into getting a renal-artery stent.”

Study Details

Patients could be enrolled in CORAL with renal-artery stenosis of 60% or more.

 

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Sources
1. Cooper CJ, Murphy TP, Cutlip DE, et al. Stenting and medical therapy for atherosclerotic renal-artery stenosis. N Engl J Med. 2013;Epub ahead of print.

2. Bittl JA. Treatment of atherosclerotic renovascular disease. N Engl J Med. 2013;Epub ahead of print.

 

Disclosures:

• Funding was provided by the National Heart, Lung, and Blood Institute.
• Medications were donated by AstraZeneca and Pfizer. The short-tip Angioguard device was donated by Cordis, and supplemental financial support was provided by both Cordis and Pfizer.
• Drs. Cooper and Bittl report no relevant conflicts of interest.

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