Ijichi Takeshi, Nakazawa Gaku, Torii Sho, Nagamatsu Hirofumi, Yoshikawa Ayako, Nakamura Shintaro, Souba Junko, Isobe Atsushi, Hagiwara Hitomi, Ikari Yuji
Department of Cardiology, Tokai University, School of Medicine, Kanagawa, Japan.
Department of Cardiology, Kindai University, Faculty of Medicine, Osaka, Japan.
Int J Cardiol Heart Vasc. 2021 May 11;34:100792. doi: 10.1016/j.ijcha.2021.100792. eCollection 2021 Jun.
The BP-SES has an abluminally applied biodegradable polymer that is fully resorbed after 3-4 months but may have longer-lasting effects. The aim of this study was to determine the long-term vascular response to the novel Ultimaster™ sirolimus-eluting stent (BP-SES).
BP-SESs, everolimus-eluting stents (DP-EESs), and bare metal stents were implanted in 22 coronary arteries of 15 mini-swine. All animals underwent optical frequent domain imaging (OFDI) to assess neointimal volume and quality at either 1 (n = 7) or 3 (n = 8) months and at 9 (n = 15) months and were euthanized at 9 months. Stents were subsequently histologically investigated to analyze the vascular response and maturity of neointimal tissue according to cell density.
OFDI revealed greater regression in neointimal volume from 3 to 9 months with BP-SESs than with DP-EESs (-0.6 ± 0.5 mm vs. 0.00 ± 0.4 mm, = 0.07). Although there was no significant difference between BP-SESs and DP-EESs in the inflammation score (BMS, BP-SES, and DP-EES: 0.1 ± 0.1, 0.3 ± 0.4, and 0.4 ± 0.4, respectively; < 0.0001) in histological analysis, BP-SESs showed slightly greater maturity than DP-EESs (1.8 ± 0.3, 1.7 ± 0.3, and 1.6 ± 0.3, = 0.09).
While both BP-SESs and DP-EESs showed minimal inflammatory responses at 9 months, BP-SESs showed a trend for greater neointimal maturity and regression, which may be related to earlier completion of the vascular response.
BP-SES具有一种从血管腔外应用的可生物降解聚合物，该聚合物在3 - 4个月后可完全吸收，但可能具有更持久的效果。本研究的目的是确定新型Ultimaster™西罗莫司洗脱支架（BP-SES）的长期血管反应。
将BP-SES、依维莫司洗脱支架（DP-EES）和裸金属支架植入15只小型猪的22条冠状动脉中。所有动物在1个月（n = 7）或3个月（n = 8）以及9个月（n = 15）时接受光学频域成像（OFDI）以评估新生内膜体积和质量，并在9个月时实施安乐死。随后对支架进行组织学研究，以根据细胞密度分析血管反应和新生内膜组织的成熟度。
OFDI显示，与DP-EES相比，BP-SES在3至9个月时新生内膜体积的消退更大（-0.6±0.5mm对0.00±0.4mm，P = 0.07）。尽管在组织学分析中，BP-SES和DP-EES在炎症评分方面无显著差异（BMS、BP-SES和DP-EES分别为0.1±0.1、0.3±0.4和0.4±0.4；P<0.0001），但BP-SES的成熟度略高于DP-EES（分别为1.8±0.3、1.7±0.3和1.6±0.3，P = 0.09）。
虽然BP-SES和DP-EES在9个月时均显示出最小的炎症反应，但BP-SES显示出新生内膜成熟度和消退更大的趋势，这可能与血管反应的更早完成有关。
