Safety and Efficacy of Renal Artery Stenting Following Suboptimal Renal Angioplasty for De Novo and Restenotic Ostial Lesions: Results from a Nonrandomized, Prospective Multicenter Registry

PURPOSE: This registry was designed to evaluate the Bridge Extra Support renal stent system (Medtronic, Santa Rosa, California) in the treatment of renal artery ostial lesions following suboptimal percutaneous transluminal renal angioplasty (PTRA). MATERIALS AND METHODS: This consecutive, nonrandomized, prospective, multicenter registry enrolled 188 patients between April 1999 and May 2002 with single de novo or restenotic renal artery ostial lesions (>= 70% stenosis) who underwent implantation of a balloon-expandable stent immediately following unsuccessful PTRA. Primary safety endpoints were major adverse clinical events (MACE) at 30 days and 9-12 months. The primary efficacy endpoint was absence of binary restenosis at 9-12 months with duplex ultrasonography (US). Secondary endpoints were acute success and quality-of-life (QOL) improvements (blood pressure, antihypertensive medications, renal function). The long-term effect of renal artery stenting on blood pressure and renal function was assessed to 36 months. RESULTS: The acute procedure and clinical success rates were 92.9%. At 30 days, the MACE rate was 3.2%, with no instances of target lesion revascularization (TLR). At 9-12 months, the MACE rate was 16.5%, with five (2.7%) deaths and 14 (7.4%) instances of TLR. The rate of restenosis at 9-12 months with duplex US was 12.6%, and 94% of patients had QOL improvements. A significant reduction in systolic blood pressure occurred following renal artery stenting and persisted to 36 months. CONCLUSIONS: Renal artery stenting is safe and efficacious in the treatment of single de novo and restenotic renal artery ostial lesions following suboptimal PTRA.