In vitro and in vivo evaluation of the safety and stability of the TAXUS® Paclitaxel-Eluting Coronary Stent

被引:24
作者
Boden, Mark [1 ]
Richard, Robert [1 ]
Schwarz, Marlene C. [1 ]
Kangas, Steve [1 ]
Huibregtse, Barbara [1 ]
Barry, James J. [1 ]
机构
[1] Boston Sci Corp, Natick, MA 01760 USA
关键词
ARTERY LESIONS; SLOW-RELEASE; POLYISOBUTYLENE; POLYSTYRENE; CARDIOLOGY; FRONTIERS; EFFICACY; POLYMERS; TRIAL;
D O I
10.1007/s10856-009-3705-5
中图分类号
R318 [生物医学工程];
学科分类号
0831 ;
摘要
Functional aspects of the styrene-b-isobutylene-b-styrene triblock copolymer (SIBS) which is incorporated into a drug-eluting stent (DES) coating are described. The SIBS copolymer is employed on the TAXUS (R) Paclitaxel-Eluting Coronary Stent as a carrier for paclitaxel (PTx). Optical and scanning electron microscopic analysis of stents explanted from rabbit and porcine models after 2 years and 6 months, respectively, showed that the SIBS coating maintained physical integrity. Gel permeation chromatography (GPC) of the copolymer extracted from the coating verified that no polymer degradation occurred over the same period of time. The coating on TAXUS (R) Stents was shown to maintain physical integrity after 400 million cycles of pulsatile or mechanical (tensile) fatigue, simulating 10 years real time use. Inspection of the samples compared to untested controls showed no change in the coating under these cyclic simulated conditions. Films prepared with the same formulation found on TAXUS (R) Stents maintained mechanical strength and resistance throughout the time of testing. Intentional defects introduced into the stent coating were shown to have only a minimal impact on PTx release. These data support the suitability of the SIBS copolymer as a drug carrier for DES applications.
引用
收藏
页码:1553 / 1562
页数:10
相关论文
共 17 条
[1]   Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions [J].
Colombo, A ;
Drzewiecki, J ;
Banning, A ;
Grube, E ;
Hauptmann, K ;
Silber, S ;
Dudek, D ;
Fort, S ;
Schiele, F ;
Zmudka, K ;
Guagliumi, G ;
Russell, ME .
CIRCULATION, 2003, 108 (07) :788-794
[2]   Clinical efficacy of polymer-based paclitaxel-eluting stents in the treatment of complex, long coronary artery lesions from a multicenter, randomized trial - Support for the use of drug-eluting Stents in contemporary clinical practice [J].
Dawkins, KD ;
Grube, E ;
Guagliumi, G ;
Banning, AP ;
Zmudka, K ;
Colombo, A ;
Thuesen, L ;
Hauptman, K ;
Marco, J ;
Wijns, W ;
Popma, JJ ;
Koglin, J ;
Russell, ME .
CIRCULATION, 2005, 112 (21) :3306-3313
[3]   LIVING CARBOCATIONIC POLYMERIZATION OF STYRENE IN THE PRESENCE OF PROTON TRAP [J].
FODOR, Z ;
GYOR, M ;
WANG, HC ;
FAUST, R .
JOURNAL OF MACROMOLECULAR SCIENCE-PURE AND APPLIED CHEMISTRY, 1993, A30 (05) :349-363
[4]   Six- and twelve-month results from a randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions [J].
Grube, E ;
Silber, S ;
Hauptmann, KE ;
Mueller, R ;
Buellesfeld, L ;
Gerckens, U ;
Russell, ME .
CIRCULATION, 2003, 107 (01) :38-42
[5]  
GYOR M, 1994, J MACROMOL SCI PURE, VA31, P2055
[6]   The Taxus™ drug-eluting stent:: A new paradigm in controlled drug delivery [J].
Kamath, Kalpana R. ;
Barry, James J. ;
Miller, Kathleen M. .
ADVANCED DRUG DELIVERY REVIEWS, 2006, 58 (03) :412-436
[7]   PHOTOINITIATED THERMAL-DEGRADATION OF POLYMERS .1. ELEMENTARY PROCESSES OF DEGRADATION OF POLYSTYRENE [J].
MITA, I ;
HISANO, T ;
HORIE, K ;
OKAMOTO, A .
MACROMOLECULES, 1988, 21 (10) :3003-3010
[8]  
Pazur R, 1997, J POLYM SCI POL CHEM, V35, P1689, DOI 10.1002/(SICI)1099-0518(19970715)35:9<1689::AID-POLA10>3.0.CO
[9]  
2-1
[10]   Physical characterization of controlled release of paclitaxel from the TAXUSTM Express2TM drug-eluting stent [J].
Ranade, SV ;
Miller, KM ;
Richard, RE ;
Chan, AK ;
Allen, MJ ;
Helmus, MN .
JOURNAL OF BIOMEDICAL MATERIALS RESEARCH PART A, 2004, 71A (04) :625-634