Hyun Dae Young, Han Xiongyi, Park Dae Sung, Kim Munki, Park Jun Kyu, Cho Kyung Hoon, Sim Doo Sun, Hong Young Joon, Ahn Youngkeun, Jeong Myung Ho
Department of Cardiovascular Medicine, Chonnam National University Hospital, Gwangju, Republic of Korea.
Cardiovascular Research Center, Chonnam National University Hospital, Gwangju, Korea.
Cardiol J. 2023 Feb 15;30(6):881-91. doi: 10.5603/CJ.a2023.0006.
Short-term outcomes regarding the safety and efficacy of a polymer-free everolimus-eluting stent (EES) with a nitrogen-doped titanium dioxide (N-TiO₂) film in a swine coronary model have been reported. However, the long-term results of the use of this type of stent have not yet been evaluated or compared to those of other polymer-free coronary stents. Therefore, this study aimed to determine the mid- to long-term safety and efficacy of a polymer-free EES with an N-TiO₂ film in a swine coronary model.
Polymer-free EES with N-TiO₂ films (n = 30) and polymer-free sirolimus-eluting stents (SES; n = 30) were implanted in 30 pigs. Quantitative coronary analysis and optical coherence tomography were conducted immediately and at 1 (quantitative coronary analysis only), 3, and 6 months after stenting. Histopathologic examinations were performed at 1, 3, and 6 months after stenting.
The polymer-free EES group had a lower percentage of neointimal growth than the polymer-free SES group at 3 months (22.5% ± 11.4% vs. 32.1% ± 12.3%; p < 0.001). The polymer-free EES group had a lower fibrin score than the polymer-free SES group at 1 month (1.9 ± 0.45 vs. 2.5 ± 0.54; p = 0.001). The re-endothelialization rates were similar between groups. The polymer-free EES group had a lower percentage of the area of stenosis than the polymer-free SES group throughout the follow-up period.
The novel polymer-free EES with an N-TiO₂ film has superior safety and efficacy than the polymer-free SES at the 6-month follow-up in a swine model.
已报道了在猪冠状动脉模型中使用具有氮掺杂二氧化钛(N-TiO₂)薄膜的无聚合物依维莫司洗脱支架(EES)的安全性和有效性的短期结果。然而,这种类型支架使用的长期结果尚未得到评估,也未与其他无聚合物冠状动脉支架的结果进行比较。因此,本研究旨在确定在猪冠状动脉模型中使用具有N-TiO₂薄膜的无聚合物EES的中长期安全性和有效性。
将具有N-TiO₂薄膜的无聚合物EES(n = 30)和无聚合物西罗莫司洗脱支架(SES;n = 30)植入30头猪体内。在支架置入后即刻以及1个月(仅进行定量冠状动脉分析)、3个月和6个月时进行定量冠状动脉分析和光学相干断层扫描。在支架置入后1个月、3个月和6个月进行组织病理学检查。
在3个月时,无聚合物EES组的新生内膜生长百分比低于无聚合物SES组(22.5% ± 11.4% 对 32.1% ± 12.3%;p < 0.001)。在1个月时,无聚合物EES组的纤维蛋白评分低于无聚合物SES组(1.9 ± 0.45对2.5 ± 0.54;p = 0.001)。两组之间的再内皮化率相似。在整个随访期间,无聚合物EES组的狭窄面积百分比低于无聚合物SES组。
在猪模型的6个月随访中,新型无聚合物N-TiO₂薄膜EES比无聚合物SES具有更高的安全性和有效性。