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Evaluation of a novel paclitaxel-eluting stent with a bioabsorbable polymeric surface coating in the porcine artery injury model.

AbstractPURPOSE:
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.
MATERIAL AND 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.
AuthorsFuyan Ding, Zhiqian Lu, Rongjiang Zou, Yi Zhang, Qingkui Guo, Suming Li, Jian Yang
JournalActa cardiologica (Acta Cardiol) Vol. 66 Issue 6 Pg. 765-72 (Dec 2011) ISSN: 0001-5385 [Print] England
PMID22299388 (Publication Type: Evaluation Study, Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Dioxanes
  • Polymers
  • Tubulin Modulators
  • polytrimethylene carbonate
  • Paclitaxel
Topics
  • Absorbable Implants
  • Animals
  • Constriction, Pathologic (prevention & control)
  • Dioxanes
  • Disease Models, Animal
  • Drug-Eluting Stents
  • Femoral Artery (pathology)
  • Microscopy, Electron, Scanning
  • Paclitaxel (administration & dosage, pharmacokinetics)
  • Polymers
  • Prostheses and Implants
  • Secondary Prevention
  • Swine
  • Tubulin Modulators (administration & dosage, pharmacokinetics)

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