Tissue biocompatibility of new biodegradable drug-eluting stent materials

• Published in: Journal of materials science. Materials in medicine Vol. 18; no. 8; pp. 1543 - 1547
• Main Authors: Uurto, Ilkka, Kotsar, Andres, Isotalo, Taina, Mikkonen, Joonas, Martikainen, Paula M, Kellomäki, Minna, Törmälä, Pertti, Tammela, Teuvo L J, Talja, Martti, Salenius, Juha-Pekka
• Format: Journal Article
• Language: English
• Published: United States Springer Nature B.V 01.08.2007
• Subjects: Absorbable Implants - adverse effects; Animals; Anti-Inflammatory Agents - administration & dosage; Biocompatibility; Biodegradability; Biomedical materials; Covering; Delayed-Action Preparations - adverse effects; Dexamethasone; Dexamethasone - administration & dosage; Equipment Failure Analysis; Indomethacin - administration & dosage; Lactic Acid - adverse effects; Male; Materials science; Materials Testing; Muscle, Skeletal - drug effects; Muscle, Skeletal - pathology; Myositis - etiology; Myositis - pathology; Myositis - prevention & control; Polyesters; Polymers - adverse effects; Polyvinyl chlorides; Rabbits; Rods; Stents; Stents - adverse effects; Strontium; Surgical implants
• ISSN: 0957-4530; 1573-4838
• DOI: 10.1007/s10856-007-3060-3

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.