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

Cardiovasc Intervent Radiol. 1999 Nov-Dec;22(6):468-74. doi: 10.1007/s002709900434.

Abstract

Purpose: To assess, in a multicenter setting, safety, technical results, and restenosis rate of the Palmaz stent for treatment of atherosclerotic ostial renal artery stenosis.

Methods: 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.

Results: 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.

Conclusion: 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.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Aged
  • Angioplasty, Balloon
  • Arteriosclerosis / therapy*
  • Female
  • Humans
  • Male
  • Prospective Studies
  • Radiography
  • Recurrence
  • Renal Artery / diagnostic imaging
  • Renal Artery Obstruction / therapy*
  • Safety
  • Stents* / adverse effects