In-vivo biocompatibility evaluation of stents coated with a new biodegradable elastomeric and functional polymer.
BACKGROUND
In-stent restenosis may be prevented by impregnating an antiproliferative agent in a polymer from a stent platform. This approach requires both an antiproliferative agent effective in small doses and a biocompatible polymer.


METHODS
A series of new biodegradable elastomeric poly(ester-amide)(co-PEA) polymers having functional carboxyl groups for drug conjugation were synthesized from non-toxic building blocks. The in-vivo biocompatibility was tested in porcine coronary arteries, by comparing the polymer-coated stents with bare metal stents in 10 pigs.


RESULTS
All animals survived until sacrifice 28 days later and follow-up angiography prior to sacrifice revealed identical diameter stenosis (21 +/- 23%) in both groups. Histology confirmed similar injury scores (0.34 +/- 0.34 compared with 0.34 +/- 0.32), inflammatory reaction (1.18 +/- 0.38 compared with 1.11 +/- 0.32) and area stenosis (26 +/- 17% compared with 28 +/- 22%).


CONCLUSIONS
This study suggests that the newly developed copoly(ester-amide) elastomers may be suitable for stent-based local drug delivery.
Cornell University-New York Presbyterian Hospital, New York, NY 10021, USA.
Seung H
SH
Lee
Istvan
I
Szinai
Kenneth
K
Carpenter
Ramaz
R
Katsarava
Giuli
G
Jokhadze
Chih-Chang
CC
Chu
Yanming
Y
Huang
Eric
E
Verbeken
Orville
O
Bramwell
Ivan
I
De Scheerder
Mun K
MK
Hong
D020341:Absorbable Implants; D000818:Animals; D020099:Coated Materials, Biocompatible; D003324:Coronary Artery Disease / Q000473:pathology / Q000517:prevention & control; D005069:Evaluation Studies as Topic; D011108:Polymers; D055502:Secondary Prevention; D015607:Stents; D013552:Swine
D020099:Coated Materials, Biocompatible; D011108:Polymers