The Erasme study: a multicenter study on the safety and technical results of the Palmaz stent used for the treatment of atherosclerotic ostial renal artery stenosis.

Abstract

To assess, in a multicenter setting, safety, technical results, and restenosis rate of the Palmaz stent for treatment of atherosclerotic ostial renal artery stenosis. Ten centers enrolled 106 patients (120 treated renal artery stenoses) in the study. Patient selection was based on unsuccessful percutaneous transluminal renal angioplasty (residual stenosis >/= 20%) performed for treatment of ostial stenosis >/= 50%, in patients with hypertension and/or impaired renal function. Safety was assessed by means of the complication rate, and technical results by the number of successful stent placements and occurrence of restenosis (>50%) at intraarterial angiographic follow-up. Stent placement was successful (n = 112) or partially successful (n = 5) in 117 (98%) arteries. Complications occurred in 19 procedures; seven were of serious clinical significance. Angiographic follow-up was performed in 89 of 117 (76%) cases, at a mean of 8 months (range 2. 5-18 months). Fifteen stents (16.9%) showed restenosis (at a mean of 8.5 months), of which 10 were successfully redilated. Renal artery stenting has a high technical success rate, a complication rate comparable to percutaneous transluminal renal angioplasty, and a low rate of restenosis at 8 months angiographic follow-up.