Tissue biocompatibility of new biodegradable drug-eluting stent materials.

Abstract

Drug-eluting stents are a recent innovation for endovascular and endourethral purposes. The aim of this study was to assess the biocompatibility of new biodegradable drug-eluting stent materials in vivo. Rods made of SR-PLDLA (self-reinforced poly-96L,4D: -lactic acid) covered with P(50L/50D)LA and rods made of 96L/4D SR-PLA and covered with P(50L/50D)LA including indomethacin 3.3 microg/mm(2)or dexamethasone 1.5 microg/mm(2), were inserted into the dorsal muscles of 20 rabbits serving as test animals. Rods made of silicone and organotin-positive polyvinylchloride were used as negative and positive controls. The animals were sacrificed after 1 week, 1 month, 2 months or 4 months. Histological changes attributable to the operative trauma were seen in all specimens at 1 week and 1 month. At 2 months both dexamethasone and indomethacin induced less fibrosis than the plain SR-PLDLA covered with P(50L/50D)LA without drug. At 4 months dexamethasone induced both chronic inflammatory changes and foreign body reaction, whereas the reactions in the indomethacin and drug-free plain SR-PLDLA groups were insignificant. The new biodegradable drug-eluting stent materials are highly biocompatible. Drug-eluting biodegradable stents may offer a promising new treatment modality for vascular and urethral diseases. However, further studies are needed to demonstrate their feasibility and efficacy.

• Authors: Ilkka Uurto, Andres Kotsar, Taina Isotalo, Joonas Mikkonen, Paula M Martikainen, Minna Kellomäki, Pertti Törmälä, Teuvo L J Tammela, Martti Talja, Juha-Pekka Salenius
• Journal: Journal of materials science. Materials in medicine (J Mater Sci Mater Med) Vol. 18 Issue 8 Pg. 1543-7 (Aug 2007) ISSN: 0957-4530 [Print] United States
• PMID: 17437066 (Publication Type: Evaluation Study, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents
• Delayed-Action Preparations
• Polyesters
• Polymers
• Lactic Acid
• poly(lactide)
• Dexamethasone
• Indomethacin

Topics

• Absorbable Implants (adverse effects)
• Animals
• Anti-Inflammatory Agents (administration & dosage)
• Delayed-Action Preparations (adverse effects)
• Dexamethasone (administration & dosage)
• Equipment Failure Analysis
• Indomethacin (administration & dosage)
• Lactic Acid (adverse effects)
• Male
• Materials Testing
• Muscle, Skeletal (drug effects, pathology)
• Myositis (etiology, pathology, prevention & control)
• Polyesters
• Polymers (adverse effects)
• Rabbits
• Stents (adverse effects)