Preclinical Evaluation of a Novel Polymer-free Everolimus-eluting Stent in a Mid-term Porcine Coronary Restenosis Model

Figures

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  Fig. 1. Configuration and structure of the TIGEREVOLUTION® stent. (A) The TIGEREVOLUTION® stent mounted on the balloon. (B) After balloon inflation. (C) Schematic structure of the connector. (D) Schematic cross-section of the strut. TiO2 = titanium dioxide, Co-Cr = cobalt-chromium.

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  Fig. 2. Study scheme. N = nitrogen, TiO2 = titanium dioxide, EES = everolimus-eluting stent, LAD = left anterior descending artery, LCX = left circumflex artery, RCA = right coronary artery, QCA = quantitative coronary analysis, OCT = optical coherence tomography.

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  Fig. 3. In vitro cumulative release kinetics of everolimus from the stent. The indicated values are the mean ± standard deviation (n = 10). TiO2 = titanium dioxide, PLGA = poly(lactic-co-glycolic acid). Reprinted from Int J Cardiol 2016;222:436-440 with permission from Elsevier.

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  Fig. 4. Efficacy of the TIGEREVOLUTION® stent. Coronary angiographic images of the TIGEREVOLUTION® stent (A) pre-implantation, (B) during implantation, (C) post-implantation, and (D) at the 6-month follow-up. Coronary angiographic images of the XIENCE Alpine® stent (E) pre-implantation, (F) during implantation, (G) post-implantation, and (H) at the 6-month follow-up. OCT images of the TIGEREVOLUTION® stent (I) post-implantation and (J) at the 6-month follow-up. OCT images of the XIENCE Alpine® stent (K) post-implantation and (L) at the 6-month follow-up. Volumetric analysis of the OCT images at the 6-month follow-up: (M) stent volume, (N) lumen volume, and (O) percentage area stenosis. The box displays the median value with an interquartile range. The black points represent mean values. OCT = optical coherence tomographic.

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  Fig. 5. Histopathologic analysis at the 6-month follow-up. Representative photomicrographs of hematoxylin and eosin staining of the TIGEREVOLUTION® stent (A: magnitude × 20) and XIENCE Alpine® stent (D: magnitude × 20), and high-power images (B and E: magnitude × 200). Carstairs' fibrin stain of the TIGEREVOLUTION® stent (C) and the XIENCE Alpine® stent (F) (magnitude × 20). Injury score (G), inflammation score (H), and intimal fibrin score (I). The box displays the median value with an interquartile range. The black points represent the mean values.

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  Fig. 6. Endothelialization evaluation of the TIGEREVOLUTION® stent and the XIENCE Alpine® stent at the 6-month follow-up. (A) Immunohistochemical staining of CD31 (bright green positive cells) and DAPI (magnitude x 100). (B) Percentage of CD31 coverage of the TIGEREVOLUTION® stent and the XIENCE Alpine® stent. The box displays the median value with the interquartile range. The black point displays the mean value. CD31 = cluster of differentiation; DAPI = 4′,6 diamidino-2-phenylindole.