Center for Cardiovascular Technology, Stanford University, Stanford, CA 94305-5637, USA.
Circ Cardiovasc Interv. 2011 Apr 1;4(2):146-54. doi: 10.1161/CIRCINTERVENTIONS.110.957175. Epub 2011 Mar 8.
The NEVO sirolimus-eluting stent (NEVO SES) is a novel cobalt-chromium stent combining sirolimus release from reservoirs with bioabsorbable polymer to reduce spatial and temporal polymer exposure. The aim of this study was to assess the arterial response to the NEVO SES in a randomized, blinded comparison versus the surface-coated TAXUS Liberte paclitaxel-eluting stent (TAXUS Liberté PES) in human native coronary lesions using intravascular ultrasound (IVUS).
The NEVO ResElution-I IVUS substudy enrolled 100 patients (1:1 randomization). In addition to standard IVUS variables, uniformity of neointimal distribution within stents was evaluated in 3 dimensions by computing mean neointimal thickness within 12 equally spaced radial sectors on every 1-mm cross section along the stented 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 at 6 months. The absolute variability of neointima distribution, assessed by the standard deviation of neointimal thickness within each stent, was significantly reduced with the NEVO SES compared with the TAXUS Liberté PES(0.04±0.04 mm versus 0.10±0.07 mm, P<0.0001). TAXUS Liberté PES showed significantly greater positive vessel remodeling than the NEVO SES (Δvessel volume index: 1.30±1.36 mm(3)/mm versus 0.36±0.63 mm(3)/mm, respectively, P=0.003).
The NEVO SES with focal release of sirolimus from reservoirs achieved significantly greater and more consistent suppression of neointimal hyperplasia than the surface-coated TAXUS Liberté PES. This was associated with less positive remodeling and no increased morphological or morphometric abnormalities surrounding the stent or at the stent margins.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00714883.
Nevo 西罗莫司洗脱支架（Nevo SES）是一种新型钴铬支架，它将西罗莫司从储库中释放出来，并结合可生物吸收的聚合物，以减少空间和时间聚合物暴露。本研究旨在通过血管内超声（IVUS）评估 Nevo ResElution-I 随机、盲法比较与表面涂层 Taxus Liberté 紫杉醇洗脱支架（Taxus Liberté PES）在人类原生冠状动脉病变中的动脉反应。
Nevo ResElution-I IVUS 子研究纳入 100 例患者（1:1 随机分组）。除了标准 IVUS 变量外，还通过计算每个支架 12 个等间隔的径向节段内的平均新生内膜厚度，在 3 个维度上评估支架内新生内膜分布的均匀性。Nevo SES 显示出明显较少的新生内膜增殖（新生内膜阻塞：5.5±11.0%比 11.5±9.7%，P=0.02），导致 6 个月时晚期管腔面积丢失和最大横截面狭窄更小。通过每个支架内新生内膜厚度的标准差评估，Nevo SES 的新生内膜分布绝对变异性明显低于 Taxus Liberté PES（0.04±0.04mm 比 0.10±0.07mm，P<0.0001）。Taxus Liberté PES 显示出明显更大的正血管重塑，与 Nevo SES 相比（血管容积指数变化：1.30±1.36mm³/mm 比 0.36±0.63mm³/mm，分别，P=0.003）。
Nevo SES 以储库中的局部释放西罗莫司，显著抑制了新生内膜增生，效果优于表面涂层 Taxus Liberté PES。这与较少的正性重塑以及支架周围或支架边缘无形态或形态学异常有关。
