Drug-Eluting Biodegradable Poly-D/L-Lactic Acid Vascular Stents:An Experimental Pilot Study
Authors:
- Ilkka UurtoIUIlkka Uurto
- Joonas MikkonenJMJoonas Mikkonen
- Jyrki ParkkinenJPJyrki Parkkinen
- Leo Keski-NisulaLKLeo Keski-Nisula
- Timo NevalainenTNTimo Nevalainen
- Minna KellomäkiMKMinna Kellomäki
- Pertti TörmäläPTPertti Törmälä
- Juha-Pekka SaleniusJSJuha-Pekka Salenius
- 1 June 2005
- journal article
- research article
- Published by International Society of Endovascular Specialists in Journal of Endovascular Therapy
- Vol. 12 (3) , 371-379
Abstract
To evaluate in vivo a new drug-eluting biodegradable vascular stent with respect to biocompatibility, neointimal hyperplasia formation, and reliability. Self-expanding biodegradable poly-96L/4D-lactic acid (PLA) stents with 2 drugs (PLA + dexamethasone [DEX] and PLA + simvastatin [SIM]) and 2 different coatings (PLA + P(D,L)LA and PLA + polycaprolactone [PCL]) were compared with a self-expanding stainless steel Wallstent. The stents were implanted in both common iliac arteries of 8 pigs. Prior to sacrifice at 1 month, angiography was performed to determine patency. Specimens were harvested for quantitative histomorphometry; vascular injury and inflammation scores were assigned to the stented iliac segments. All stented arteries were angiographically patent. The mean luminal diameter (3.05 mm) and area (30.36 mm2) of DEX-eluting PLA stents were decreased compared to other stents (PLA + P(D,L)LA: 3.66 mm and 43.92 mm2; PLA + SIM: 4.21 mm and 56.48 mm2; PLA + PCL: 4.19 mm and 54.64 mm2; Wallstent: 5.01 mm and 81.19 mm2). Wallstents and DEX-eluting PLA stents induced minimal intimal hyperplasia: PLA + DEX: 0.16 mm, PLA + P(D,L)LA: 0.35 mm, PLA + SIM: 0.33 mm, PLA + PCL: 0.29 mm, and Wallstent: 0.18 mm. The vascular injury scores demonstrated only mild vascular trauma for all stents. Only mild to moderate inflammatory reaction was noted around stent struts with a vascular inflammation score. Biodegradable polymer stents appear to be biocompatible and reliable, causing minimal neointimal hyperplasia. Furthermore, the new biodegradable poly-D/L-lactic acid stent can be used as a local drug delivery vehicle. The DEX-eluting PLA stent reduces neointimal hyperplasia. The findings show a need for further investigation to prove the efficacy and safety of this new biodegradable drug-eluting stent.Keywords
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