Tissue biocompatibility of new biodegradable drug-eluting stent materials.
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.
Uurto
Ilkka
I
Department of Surgery, Satakunta Central Hospital, Pori, Finland. ilkka.uurto@uta.fi
Kotsar
Andres
A
Isotalo
Taina
T
Mikkonen
Joonas
J
Martikainen
Paula M
PM
Kellomäki
Minna
M
Törmälä
Pertti
P
Tammela
Teuvo L J
TL
Talja
Martti
M
Salenius
Juha-Pekka
JP
D020341:Absorbable Implants / Q000009:adverse effects; D000818:Animals; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage; D003692:Delayed-Action Preparations / Q000009:adverse effects*; D003907:Dexamethasone / Q000008:administration & dosage; D019544:Equipment Failure Analysis; D007213:Indomethacin / Q000008:administration & dosage; D019344:Lactic Acid / Q000009:adverse effects*; D008297:Male; D008422:Materials Testing; D018482:Muscle, Skeletal / Q000187:drug effects* / Q000473:pathology*; D009220:Myositis / Q000209:etiology* / Q000473:pathology / Q000517:prevention & control*; D011091:Polyesters; D011108:Polymers / Q000009:adverse effects*; D011817:Rabbits; D015607:Stents / Q000009:adverse effects*
D000893:Anti-Inflammatory Agents; D003692:Delayed-Action Preparations; D011091:Polyesters; D011108:Polymers; D019344:Lactic Acid; C033616:poly(lactide); D003907:Dexamethasone; D007213:Indomethacin