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Revista Española de Cardiología (English Edition) Revista Española de Cardiología (English Edition)
Rev Esp Cardiol. 2017;70:1059-66 - Vol. 70 Num.12 DOI: 10.1016/j.rec.2017.05.021

Safety and Efficacy of New Biodegradable Polymer-based Sirolimus-Eluting Stents in a Preclinical Model

Armando Pérez de Prado a,, Claudia Pérez Martínez a, Carlos Cuellas Ramón a, Marta Regueiro Purriños a, María López Benito a, José Manuel Gonzalo Orden a, José Antonio Rodríguez Altónaga a, Rodrigo Estévez Loureiro a, Tomás Benito González a, David Viñuela Baragaño a, María Molina Crisol b, Marc Amorós Aguilar b, Isabel Pérez Serranos b, Arnau Vidal Parreu b, Ana Benavides Montegordo b, Luis Duocastella Codina b, Felipe Fernández Vázquez a

a Grupo Cardiovascular (HemoLeon), Fundación Investigación Sanitaria en León y del Instituto de Biomedicina (IBIOMED), Universidad de León, Hospital Universitario de León, León, Spain
b Life Vascular Devices (LVD) Biotech, iVascular, Barcelona, Spain

Keywords

Preclinical model. Drug-eluting stent. Restenosis. Vascular healing.

Abstract

Introduction and objectives

New drug-eluting stents (DES) designed to overcome the limitations of existing devices should initially be tested in preclinical studies. Our objective was to analyze the safety and efficacy of new biodegradable polymer-based DES compared with bare-metal stents (BMS) and commercially available DES in a model of normal porcine coronary arteries.

Methods

We randomly implanted 101 stents (BMS and biodegradable polymer-based sirolimus-eluting stents: 3 test stent iterations [BD1, BD2, and BD3], Orsiro, Biomime and Biomatrix) in the coronary arteries of 34 domestic pigs. Angiographic and histomorphometric studies were conducted 1 month (n = 83) and 3 months (n = 18) later.

Results

The stents were implanted at a stent/artery ratio of 1.31 ± 0.21, with no significant differences between groups. At 1 month, the new test stents (BD1, BD2 and BD3) showed less late loss and angiographic restenosis, as well as lower histologic restenosis and neointimal area (P < .0005), than the BMS. There were no differences in endothelialization, vascular injury, or inflammation between the new test stents and BMS, although the new stents showed higher fibrin deposition (P = .0006). At 3 months, all these differences disappeared, except for a lower neointimal area with the new BD1 stent (P = .027). No differences at any time point were observed between the new test stents and commercially available controls.

Conclusions

In this preclinical model, the new biodegradable polymer-based DES studied showed less restenosis than BMS and no significant differences in safety or efficacy vs commercially available DES.

Article

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1885-5857/© 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved