载紫杉醇氟聚合物对新生内膜增殖和血管愈合的影响：家族性高胆固醇血症猪股部再狭窄模型中外周药物洗脱支架的对比研究。
Impact of Fluoropolymer-Based Paclitaxel Delivery on Neointimal Proliferation and Vascular Healing: A Comparative Peripheral Drug-Eluting Stent Study in the Familial Hypercholesterolemic Swine Model of Femoral Restenosis.
机构信息
From the CRF-Skirball Center for Innovation, Orangeburg, NY (P.G., Y.C., A.F.V., J.M., G.B.C., G.L.K., J.F.G.); and Third Department of Cardiology, Medical University of Silesia, Katowice, Poland (P.G.).
出版信息
Circ Cardiovasc Interv. 2017 May;10(5). doi: 10.1161/CIRCINTERVENTIONS.116.004450.
BACKGROUND
A polymer-free peripheral paclitaxel-eluting stent (PES, Zilver PTX, Cook, IN) has shown to improve vessel patency after superficial femoral angioplasty. A new-generation fluoropolymer-based PES (FP-PES; Eluvia, Boston Scientific, MA) displaying more controlled and sustained paclitaxel delivery promise to improve the clinical outcomes of first-generation PES. We sought to compare the biological effect of paclitaxel delivered by 2 different stent-coating technologies (fluoropolymer-based versus polymer-free) on neointimal proliferation and healing response in the familial hypercholesterolemic swine model of femoral restenosis.
METHODS AND RESULTS
The biological efficacy of clinically available FP-PES (n=12) and PES (n=12) was compared against a bare metal stent control (n=12; Innova, Boston Scientific, MA) after implantation in the femoral arteries of 18 familial hypercholesterolemic swine. Longitudinal quantitative vascular angiography and optical coherence tomography were performed at baseline and at 30 and 90 days. Histological evaluation was performed at 90 days. Ninety-day quantitative vascular angiography results showed a lower percent diameter stenosis for FP-PES (38.78% [31.27-47.66]) compared with PES (54.16% [42.60-61.97]) and bare metal stent (74.52% [47.23-100.00]; <0.001). Ninety-day optical coherence tomography results demonstrated significantly lower neointimal area in FP-PES (8.01 mm [7.65-9.21]) compared with PES (10.95 mm [9.64-12.46]) and bare metal stent (13.83 mm [11.53-17.03]; <0.001). Histological evaluation showed larger lumen areas and evidence of higher biological activity (smooth muscle cell loss and fibrin deposition) in the FP-PES compared with PES and bare metal stent.
CONCLUSIONS
In the familial hypercholesterolemic swine model of femoral restenosis, the implantation of an FP-PES resulted in lower levels of neointimal proliferation and sustained biological effect ≤90 days compared with a polymer-free stent-based approach.
背景
一种无聚合物的外周紫杉醇洗脱支架（PES，Zilver PTX，库克，IN）已显示可改善股浅动脉成形术后的血管通畅性。一种新的基于氟聚合物的 PES（FP-PES；波士顿科学公司的 Eluvia）显示出更能控制和持续释放紫杉醇，有望改善第一代 PES 的临床结果。我们旨在比较两种不同支架涂层技术（基于氟聚合物与无聚合物）在家族性高胆固醇血症猪股浅动脉再狭窄模型中对新生内膜增殖和愈合反应的生物学作用。
方法和结果
在 18 只家族性高胆固醇血症猪的股动脉中分别植入临床可用的 FP-PES（n=12）和 PES（n=12），并与裸金属支架对照（n=12；波士顿科学公司的 Innova）进行比较。在基线和 30 天和 90 天进行纵向定量血管造影和光学相干断层扫描。在 90 天进行组织学评估。90 天的定量血管造影结果显示，FP-PES 的百分比狭窄率较低（38.78%[31.27-47.66]），与 PES（54.16%[42.60-61.97]）和裸金属支架（74.52%[47.23-100.00]）相比（<0.001）。90 天的光学相干断层扫描结果显示，FP-PES 的新生内膜面积明显低于 PES（8.01mm[7.65-9.21]）和裸金属支架（10.95mm[9.64-12.46]）（<0.001）。组织学评估显示，与 PES 和裸金属支架相比，FP-PES 具有更大的管腔面积和更高的生物学活性证据（平滑肌细胞丢失和纤维蛋白沉积）。
结论
在家族性高胆固醇血症猪股浅动脉再狭窄模型中，与无聚合物支架方法相比，FP-PES 的植入导致新生内膜增殖水平较低，且≤90 天的持续生物学作用。
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