Evaluation of a novel paclitaxel-eluting stent with a bioabsorbable polymeric surface coating in the porcine artery injury model.
OBJECTIVE
Drug-eluting stents (DES) are unique in allowing sustained release after a single short intervention. The challenge with DES still remaining is the optimal combination of a biocompatible drug-eluting matrix including an antiproliferative drug. We studied the role of a novel paclitaxel-eluting stent with a bioabsorbable polymer coating in preventing vascular restenosis in the porcine artery injury model.


METHODS
Bare metal stents (BMS); polymer-coated-only stents (POLY); and polymer-based paclitaxel-eluting stents (PACL) were randomly implanted in pig femoral arteries. The dose density of paclitaxel was 1 microg/mm2 with in vitro studies demonstrating a gradual elution over a course of 6 month.


RESULTS
After 1-, 3- and 6-month follow-up, respectively, the animals underwent angiographic restudy and were terminated for histomorphometrical and histopathological analyses. At 1 month, the PACL group had the lowest histological percent stenosis when compared to the BMS and POLY groups (20 +/- 4% vs 39 +/- 6% and 41 +/- 6%, respectively, P < 0.05). At 3 months, the PACL group still presents the lowest level of histological percent stenosis among the three groups (27 +/- 6% vs 50 +/- 10% and 46 +/- 5%, respectively, P < 0.01). Six months later, the PACL group showed a similar histological percent stenosis as the BMS and POLY groups (44 +/- 9% vs 56 +/- 11% and 53 +/- 9%, respectively, P = 0.145).


CONCLUSIONS
This study shows favourable vascular compatibility and efficacy for a novel DES to inhibit in-stent neointima formation and preserve lumen area in the porcine artery model.
Department of Cardio-thoracic Surgery, Sixth People's Hospital, Shanghai Jiao Tong University, Shanghai, China.
Fuyan
F
Ding
Zhiqian
Z
Lu
Rongjiang
R
Zou
Yi
Y
Zhang
Qingkui
Q
Guo
Suming
S
Li
Jian
J
Yang
D020341:Absorbable Implants; D000818:Animals; D003251:Constriction, Pathologic / Q000517:prevention & control; D004146:Dioxanes; D004195:Disease Models, Animal; D054855:Drug-Eluting Stents; D005263:Femoral Artery / Q000473:pathology; D008855:Microscopy, Electron, Scanning; D017239:Paclitaxel / Q000008:administration & dosage* / Q000493:pharmacokinetics; D011108:Polymers; D019736:Prostheses and Implants; D055502:Secondary Prevention; D013552:Swine; D050257:Tubulin Modulators / Q000008:administration & dosage* / Q000493:pharmacokinetics
D004146:Dioxanes; D011108:Polymers; D050257:Tubulin Modulators; C059299:polytrimethylene carbonate; D017239:Paclitaxel