RESUMEN
Aims: Novolimus, a macrocyclic lactone with anti-proliferative properties, has asimilar efficacy to currently available agents; however it requires a lower dose,and less polymer, and is therefore conceivably safer.Methods and results: The EXCELLA II study was a prospective, multicentre,single-blind, non-inferiority clinical trial which randomised 210 patients with a maximum of two de novo coronary artery lesions in two different epicardialvessels in a ratio of 2:1 to treatment with either the Elixir DESyne NovolimusEluting Coronary Stent System (NES n=139, Elixir Medical, Sunnyvale, CA, USA)or the Endeavor zotarolimus eluting stent (ZES n=71, Medtronic, Santa Rosa, CA,USA). The primary endpoint was in-stent mean late lumen loss (LLL) at 9-monthsfollow-up. In-stent percent volume obstruction (%VO) was measured in asub-group of 65 patients having 9-month intravascular ultrasound (IVUS) follow-up.Clinical secondary endpoints included a device orientated composite of cardiacdeath, target vessel myocardial infarction (MI), and clinically indicated target lesionrevascularisation (CI-TLR) assessed at 9-months follow-up. At 9-months, thein-stent LLL was 0.11±0.32 mm in the NES arm, as compared to 0.63±0.42 mm inthe ZES (p<0.0001 non-inferiority, p<0.0001 superiority). In-stent%VO was4.5±5.1% and 20.9±11.3% for NES and ZES, respectively (p<0.001). There wasno significant difference between stent groups in the device orientated compositeendpoint (NES 2.9% vs. ZES 5.6%, 2.8% [-8.8%, 3.3%], p=0.45) or its individualcomponents of cardiac death, target vessel MI and CI-TLR.Conclusions: This non-inferiority randomised study not only met its primaryendpoint, but also demonstrated superiority of NES compared to the ZES in terms of in-stent LLL.
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Angioplastia , Infarto del Miocardio , Revascularización MiocárdicaRESUMEN
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.