Histological and Mechanical Behavior of INC 01 and 02 Bare Metal Stents Against a Commercial Stent: A Preclinical Study in a Porcine Model

PCI is an expensive procedure in our population and it implies a huge cost for the institutions and National Health Service. The main objective was to evaluate the technical and biological success of two stents designed in Mexico. Ten York pigs, 4–6 months of age, underwent implantation of the bare metal INC-01 (10 stents) and INC-02 (6 stents) coronary stent in addition to a conventional commercial stent (10 stents). Technical success was evaluated immediately with angiography and Intravascular Ultrasound IVUS, continued by a mean follow-up of 4 month and a final angiographic, IVUS and histological evaluation. Initial technical success, angiography and IVUS between the three stents were not significant. One stent presented restenosis in follow-up (commercial stent), but all other stents presented excellent clinical outcome, satisfactory angiographic and IVUS results. Inflammation, proliferation and endothelialization between the stents had no major differences in histological analysis in a mean of 4 months follow-up. In this pig model, the INC 01 and INC 02 stents showed the same delivering technical success, angiographic and IVUS features, biological and histological response compared to commercial last generation stents.