CORAL Compares Renal Artery Stenting With Optimal Medical Therapy

Timothy F. Kirn

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LAS VEGAS -- The current evidence regarding endovascular renal artery stenting suggests it is beneficial, but a number of important questions remain, Thomas M. Shimshak, M.D., said at a meeting on peripheral vascular interventions sponsored by Medical Media Communications.

Those questions include whether it really is better than optimal medical therapy in patients with confirmed renal artery stenosis--a question that will be assessed directly in the CORAL (Cardiovascular Outcomes in Renal Atherosclerotic Lesions) trial, currently enrolling patients and expected finish in 2010.

Current evidence suggests the procedure is successful in about 90% of cases and that at 9 months, 80% of those renal arteries are still patent. Blood pressure is improved or does not change (i.e., no worsening) in almost 90% of patients at 12 months, and renal function is improved or unchanged in 94%, though it is only a small percentage in which renal function is improved.

The restenosis rate, even with stenting, appears to be a major improvement over that with angioplasty alone. But a major problem is that the best way to address restenosis is unknown, said Dr. Shimshak, an interventional cardiologist in Milwaukee. One trial compared a drug-eluting (sirolimus) stent with a bare-metal stent and found no significant advantage to the use of a drug-eluting stent, though there was a hint of one.

"The question remains whether other agents may show a benefit," he said.

The final question regards distal protection. In other systems, such as with the saphenous vein, distal protection has been shown to be beneficial. It is an open question whether such benefits would accrue in renal stenting. Atheromatous emboli certainly occur during renal artery stenting, and may compromise renal function, though that has not been proven, Dr. Shimshak said.

Reports of small series of patients have suggested some advantage when distal protection is used. But, the final answer of whether distal protection really is necessary is awaiting the results of another controlled trial currently underway.

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