Background: 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.
Methods: 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.
Results: 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.
Conclusions: 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.
Keywords: drug-eluting stent; optical coherence tomography; polymer; restenosis; titanium dioxide.