ABSTRACT
BackgroundThe NEVO sirolimus-eluting stent (NEVO SES) is a novel cobalt-chromium stent combining sirolimusrelease from reservoirs with bioabsorbable polymer to reduce spatial and temporal polymer exposure. The aim of thisstudy was to assess the arterial response to the NEVO SES in a randomized, blinded comparison versus thesurface-coated TAXUS Liberte paclitaxel-eluting stent (TAXUS Liberte´ PES) in human native coronary lesions usingintravascular ultrasound (IVUS).Methods and ResultsThe NEVO ResElution-I IVUS substudy enrolled 100 patients (1:1 randomization). In addition tostandard IVUS variables, uniformity of neointimal distribution within stents was evaluated in 3 dimensions bycomputing mean neointimal thickness within 12 equally spaced radial sectors on every 1-mm cross section along thestented segment. The NEVO SES showed significantly less neointimal proliferation (neointimal obstruction: 5.5 11.0%versus 11.5 9.7%, P 0.02), resulting in less late lumen area loss and smaller maximum cross-sectional narrowing at6 months. The absolute variability of neointima distribution, assessed by the standard deviation of neointimal thicknesswithin each stent, was significantly reduced with the NEVO SES compared with the TAXUS Liberte´PES(0.04 0.04 mm versus 0.10 0.07 mm, P 0.0001). TAXUS Liberte´ PES showed significantly greater positivevessel remodeling than the NEVO SES ( vessel volume index: 1.30 1.36 mm3/mm versus 0.36 0.63 mm3/mm,respectively, P 0.003).ConclusionsThe NEVO SES with focal release of sirolimus from reservoirs achieved significantly greater and moreconsistent suppression of neointimal hyperplasia than the surface-coated TAXUS Liberte´ PES. This was associated withless positive remodeling and no increased morphological or morphometric abnormalities surrounding the stent or at thestent margins.