Objective: The multicenter, single-arm RENAISSANCE trial evaluated outcomes in patients with progressive atherosclerotic renal artery stenosis (ARAS) treated with the Express Renal Premounted Stent System (Boston Scientific, Natick, MA).
Background: Renal artery stenting may prevent the morbidity and mortality of surgical revascularization and high restenosis rates of percutaneous renal angioplasty (PTRA). Renal artery duplex ultrasonography (DUS) offers an alternative to traditional invasive poststenting angiographic surveillance, though concordance with angiography for in-stent restenosis has yet to be validated independently.
Methods: RENAISSANCE enrolled 100 patients (117 lesions) with de novo or restenotic ostial atherosclerotic lesions <or=15 mm long in vessels >or=4.0 and <or=7.0 mm diameter with diameter stenosis >or=70%. The primary endpoint, 9-month binary restenosis, was compared to an objective performance criterion (OPC) of 40% for published PTRA results. Follow-up was conducted through 3 years.
Results: Technical and procedural success was both 99%. Follow-up angiography, triggered clinically or by ultrasonography, revealed 21.3% binary restenosis at 9 months, which was superior to the OPC (P < 0.0001). Concordance between ultrasonography and angiography for detection of binary restenosis at 9 months was 87%. Peak systolic velocity and renal-to-aortic ratio were both significantly improved compared to baseline at 9 months and 2 years. The major adverse event (defined as device- or procedure-related death, target lesion revascularization or significant embolic event) rate was 10.5% at 9 months and 20.9% at 3 years.
Conclusions: RENAISSANCE demonstrates that renal artery stenting is superior to the prespecified OPC at 9 months, and also shows that DUS can accurately identify in-stent restenosis.
(c) 2008 Wiley-Liss, Inc.