Copyright © 2004 by the European Society of Cardiology.
Preclinical research
Long-term assessment of a novel biodegradable paclitaxel-eluting coronary polylactide stent
a Medical Clinic I, University Hospital Aachen, Pauwelsstrasse 30, 52074 Aachen, Germany
b Interdisciplinary Center for Clinical Research in Biomaterials and Tissue–Material-Interaction in Implants "BIOMAT", University Hospital, Aachen, Germany
c Institute of Plastics Processing, RWTH Aachen University, 52074 Aachen, Germany
d Institute of Pathology, University Regensburg, 93053 Regensburg, Germany
e Department of Molecular Cardiovascular Research, University Hospital, Aachen Germany
Received January 14, 2004;
revised May 24, 2004;
accepted June 3, 2004
* Corresponding author. Tel.: +49-241-8089300; fax: +49-2421-959262
E-mail address: ruediger.blindt{at}post.rwth-aachen.de
Aim The aim of this study was to assess technical feasibility, biocompatibility, and impact on coronary stenosis of a new biodegradable paclitaxel-loaded polylactide stent. Due to high rates of in-stent restenosis and permanent nature of metal stent implants, synthetic polymers have been proposed as surrogate materials for stents and local delivery systems for drugs. Paclitaxel was shown to inhibit vascular smooth muscle cell proliferation and migration.
Methods and results A novel biodegradable double-helical stent was manufactured using controlled expansion of saturated polymers (CESP) for the moulding of a bioresorbable poly(D,L)-lactic acid (PDLLA). A modified balloon catheter for stent deployment was developed according to the mechanical stent properties. Twelve paclitaxel-loaded (170 µg) polylactide stents, 12 unloaded polylactide stents, and 12 316L bare metal stents were deployed in porcine coronary arteries of 36 animals. Six pigs of each group were sacrificed after 3 weeks and 3 months, respectively, for every setting. Drug release kinetics as well as histomorphometrical and histopathological analyses were performed. A slow paclitaxel release kinetic for more than 2 months and therapeutic tissue concentrations were demonstrated. Coronary stenosis after implantation of paclitaxel-loaded stents (30±5% or 49±4%) was significantly inhibited compared to unloaded PDLLA stents (65±10%, 
or 71±4%, 
) and metal stents (53±6% or 68±8%, 
and 
) after 3 weeks or 3 months. Early complete endothelialisation was shown. Nevertheless, a local inflammatory response to the polylactide as a result of the polymer resorption process was observed.
Conclusions This novel polylactide stent showed sufficient mechanic stability, and by incorporation of paclitaxel, a significant potential to reduce restenosis development after vascular intervention was seen.
Key Words: Stents • Polymer • Restenosis • Paclitaxel
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