Intravascular Ultrasound Results From the NEVO ResElution-I Trial

Abstract

Background-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). Methods and Results-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: 5.5Ϯ11.0% versus 11.5Ϯ9.7%, Pϭ0.02), 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 (

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“…Given that sirolimus has shown greater efficacy than paclitaxel to prevent neointimal proliferation in multiple studies, [28][29][30] it could be of interest to evaluate the Stentys sirolimus-eluting stent in longer BTK lesions.…”

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“…One of the potential benefits of the reservoir technique for localized drug delivery on a stent, is that the surface area of polymer exposure to the vessel is reduced, which may help to reduce sensitivity or inflammatory responses to polymer that result in events. Furthermore, the NEVO SES elutes sirolimus within 90 days from implant while the PGLA degrades, leaving only a bare metal scaffold in place which may help reduce ST attributed to permanent polymer coatings (Otake et al, 2011a).…”

“…Numerically lower rates of MACE, death, MI, and revascularization have also been demonstrated in favor of the NEVO SES arm compared to the TAXUS Liberté arm through 24 months, as well as no events of ST in the NEVO SES arm (Spaulding, 2011). The NEVO ResElution-1 IVUS sub-study was also conducted and enrolled 100 patients and had 3D intravascular ultrasound (IVUS) studies available on 64 patients at 6 months, which showed that a significant reduction in neointimal obstruction occurred in the NEVO SES arm (5.5 ± 11.0%) compared to the TAXUS Liberté arm (11.5 ± 9.7%), p = 0.02 (Otake et al, 2011a). There was no event of ST in the NEVO SES arm at 6 months compared to 1 event in the TAXUS Liberté arm, and clinical outcomes were overall comparable for death, MI, and TLR (Otake et al, 2011a).…”

“…As mentioned earlier, the NEVO stent was a new technology in development by Cordis Corporation, Johnson and Johnson, and used polylactic-co-glycolic acid (PGLA) loaded in reservoirs drilled through the struts of a cobalt chromium stent and has subsequently been removed from further development (Belardi, 2011;Otake et al, 2011b). The JACTAX™ biodegradable stent system is developed by Boston Scientific and uses D-lactic polylactic acid (DLPLA) mounted on the TAXUS Liberté stent whose outside coating elutes paclitaxel (Grube et al, 2010;Shand, 2010) .…”