Nanospheres encapsulated everolimus delivery into arterial wall-the tissue pharmacokinetics and vascular response experimental study.

Autor: Milewski K; Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland.; Institute of Physiotherapy and Health Sciences, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland., Bryła-Wojciechowska A; Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland., Buszman PP; Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland.; Cardiology Department, Andrzej Frycz Modrzewski Krakow University, Kraków, Poland, Krakow, Poland., Jelonek K; Centre of Polymer and Carbon Materials, Polish Academy of Sciences, Zabrze, Poland., Kachel M; Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland., Gąsior P; Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland.; Division of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland, Medical University of Silesia, Katowice, Poland., Krauze A; Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland., Błachut A; Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland.; Department of Cardiology, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Katowice, Poland., Musiał-Kulik M; Centre of Polymer and Carbon Materials, Polish Academy of Sciences, Zabrze, Poland., Tellez A; StageBio, Inc., Thurmont, Maryland, USA., Rousselle SD; StageBio, Inc., Thurmont, Maryland, USA., Kiesz RS; San Antonio Endovascular and Heart Institute, Texas, USA.; University of Texas Health Sciences Center, San Antonio, Texas, USA., Kasperczyk J; Centre of Polymer and Carbon Materials, Polish Academy of Sciences, Zabrze, Poland., Buszman PE; Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland.; Medical University of Silesia, Katowice, Poland.
Jazyk: angličtina
Zdroj: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions [Catheter Cardiovasc Interv] 2021 Nov 01; Vol. 98 (5), pp. 914-922. Date of Electronic Publication: 2020 Sep 18.
DOI: 10.1002/ccd.29258
Abstrakt: Objective: This study aimed to evaluate the pharmacokinetic profile and tissue effects of everolimus delivered into arterial wall using biodegradable nanospheres.
Background: Delivery of everolimus into the arterial wall is challenging due to its low-lipophilic profile.
Methods: A pharmacokinetic study included 28 porcine coronary arterial segments initially injured with balloon angioplasty followed by the local delivery of everolimus encapsulated in nanospheres (EEN) via injection through a microporous delivery catheter. The animals were sacrificed at 1 hour, 1,7,28, and 90-day follow-up. In the tissue effects study 16 coronary bare metal stent (BMS) were implanted following EEN delivery, 15 BMS following nanospheres delivery without the drug (reference group) and 16 implanted BMS served as a control. Angiographic and histology follow-up was scheduled at 28 and 90-day.
Results: The study showed high-everolimus concentrations in arterial tissue early after nanoparticles delivery followed by its gradual decrease to 1.15 ± 0.40 ng/mg at 90 days. Histology analysis showed favorable biocompatibility and healing profile with comparable area stenosis between groups at both time-points.
Conclusions: The present study demonstrates for the first time the safety, biocompatibility, and long-term retention of everolimus in arterial tissue after single local delivery of biodegradable nanospheres.
(© 2020 Wiley Periodicals LLC.)
Databáze: MEDLINE
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