Comparative Analysis of the Paclitaxel-Eluting Peripheral Igaki-Tamai Stent and the Drug-Free Igaki-Tamai Stent Using Optical Coherence Tomography and Histological Analysis in a Porcine Iliac Artery Model
- 24 April 2020
- journal article
- research article
- Published by Japanese Circulation Society in Circulation Journal
- Vol. 84 (5), 799-805
- https://doi.org/10.1253/circj.cj-20-0040
Abstract
Background:The combination of a bioresorbable scaffold and antiproliferative drugs is a promising treatment for peripheral artery disease. The novel paclitaxel-eluting peripheral Igaki-Tamai stent (PTX-ITS) has the same backbone design as the drug-free peripheral Igaki-Tamai stent and a paclitaxel coating. Arterial responses to the PTX-ITS and ITS using optical coherence tomography (OCT) and histological analysis in a porcine iliac artery model were compared. Methods and Results:In total, 6 PTX-ITSs and 6 ITSs implanted in porcine iliac arteries were evaluated. Quantitative measurements of the scaffold, lumen, neointimal areas, and percent area stenosis were performed using OCT at 1 and 3 months. Histological evaluations (PTX-ITS [n=5], ITS [n=4]) were performed following euthanasia at 3 months. Injury, inflammation, endothelialization, and fibrin scores were measured. Baseline angiographic characteristics were similar in both groups. The ITS group showed significantly smaller scaffold areas than the PTX-ITS group at 1 month (18.50±3.62 mm2vs. 23.54±3.64 mm2; P=0.037) and 3 months (15.82±2.57 mm2vs. 21.67±3.57 mm2; P=0.009). Percent area stenosis was significantly lower in the PTX-ITS group at 3 months (28.70±7.24% vs. 40.36±7.07%; P=0.018). Histological evaluations revealed similar low-grade inflammatory reactions for both scaffolds. Conclusions:PTX-ITSs showed significantly better suppression of late scaffold shrinkage and lower in-scaffold stenosis for up to 3 months. Additionally, PTX-ITSs exhibited high biocompatibility, which is comparable to ITSs.Keywords
This publication has 21 references indexed in Scilit:
- Comparative analysis method of permanent metallic stents (XIENCE) and bioresorbable poly-L-lactic (PLLA) scaffolds (Absorb) on optical coherence tomography at baseline and follow-upEuroIntervention, 2016
- Treatment of the femoropopliteal artery with the bioresorbable REMEDY stentJournal of Vascular Surgery, 2016
- Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal DiseaseJournal of Endovascular Therapy, 2016
- A New Approach for Polymer-Free Coating with Paclitaxel Microparticles on Fully-Bioabsorbable Poly(l-Lactic Acid) Stent and Studies of Drug Release BehaviorInternational Journal of Drug Delivery Technology, 2015
- Drug-Coated Balloon Versus Standard Percutaneous Transluminal Angioplasty for the Treatment of Superficial Femoral and Popliteal Peripheral Artery DiseaseCirculation, 2015
- Evaluation of the Biodegradable Peripheral Igaki-Tamai Stent in the Treatment of De Novo Lesions in the Superficial Femoral ArteryJACC: Cardiovascular Interventions, 2014
- Long-Term (>10 Years) Clinical Outcomes of First-in-Human Biodegradable Poly- l -Lactic Acid Coronary StentsCirculation, 2012
- Paclitaxel-Eluting Stents Show Superiority to Balloon Angioplasty and Bare Metal Stents in Femoropopliteal DiseaseCirculation: Cardiovascular Interventions, 2011
- Treatment of Coronary In-Stent Restenosis with a Paclitaxel-Coated Balloon CatheterThe New England Journal of Medicine, 2006
- A Paclitaxel-Eluting Stent for the Prevention of Coronary RestenosisThe New England Journal of Medicine, 2003