Biological Effect on Drug Distribution and Vascular Healing Via Paclitaxel-Coated Balloon Technology in Drug Eluting Stent Restenosis Swine Model
Biological Effect on Drug Distribution and Vascular Healing Via Paclitaxel-Coated Balloon Technology in Drug Eluting Stent Restenosis Swine Model
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DOI：
10.1002/ccd.26278
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发表时间：
2016-07-01
影响因子：
2.3
通讯作者：
Granada, Juan F.
中科院分区：
文献类型：
--
作者：
Li, Yan;Tellez, Armando;Granada, Juan F.
目的：评估紫杉醇涂层球囊（PCB）技术对药物洗脱支架再狭窄（DES-ISR）猪模型血管药物分布和愈合的生物学效应。背景：DES-ISR 中 PCB 技术的作用机制和愈合反应尚不完全清楚。方法：将27个裸金属支架植入冠状动脉，30天后用PCB治疗支架内再狭窄。在处理后1小时、14天和30天收获处理过的节段用于药代动力学分析。此外，将 24 个 DES 植入冠状动脉 30 天，然后用 PCB (n = 12) 或未涂层球囊 (n = 12) 处理所有 DES-ISR。第60天，在血管造影和光学相干断层扫描（OCT）后收获血管用于组织学分析。结果：在 1 小时 Cmax 时，新内膜组织中的紫杉醇水平比血管壁中的紫杉醇水平高约 18 倍（P = 0.0004），并且在第 60 天时保留的紫杉醇水平比血管壁中的紫杉醇水平高约 5 倍（P = 0.008）。通过使用荧光标记的紫杉醇证明了 ISR 中紫杉醇的均匀分布。值得注意的是，在 DES-ISR 中，与未涂层球囊相比，PCB 术后终止 OCT 和定量冠状动脉成形术均显示显着的新内膜减少和晚期管腔损失较少（分别为 P = 0.05 和 P = 0.03）。与-limus DES-ISR + PCB 组相比，PES-ISR1PCB 组显示出更高水平的支柱周围炎症和纤维蛋白评分。结论：在 ISR 中，紫杉醇主要沉积在新内膜组织中，并在使用 PCB 后随时间有效保留。尽管存在金属支柱，但仍具有均匀分布的特征。 PCB 在 DES-ISR 中表现出同等的生物学效应，且不会显着增加炎症。 (C) 2015 年 Wiley 期刊公司。
Objectives: To evaluate the biological effect of a paclitaxel-coated balloon (PCB) technology on vascular drug distribution and healing in drug eluting stent restenosis (DES-ISR) swine model. Background: The mechanism of action and healing response via PCB technology in DES-ISR is not completely understood. Methods: A total of 27 bare metal stents were implanted in coronary arteries and 30 days later the in-stent restenosis was treated with PCB. Treated segments were harvested at 1 hr, 14 days and 30 days post treatment for the pharmacokinetic analysis. In addition, 24 DES were implanted in coronary arteries for 30 days, then all DES-ISRs were treated with either PCB (n = 12) or uncoated balloon (n = 12). At day 60, vessels were harvested for histology following angiography and optical coherence tomography (OCT). Results: The paclitaxel level in neointimal tissue was about 18 times higher (P = 0.0004) at 1 hr Cmax, and retained about five times higher (P = 0.008) at day 60 than that in vessel wall. A homogenous distribution of paclitaxel in ISR was demonstrated by using fluorescently labeled paclitaxel. Notably, in DES-ISR, both termination OCT and quantitative coronary angioplasty showed a significant neointimal reduction and less late lumen loss (P = 0.05 and P = 0.03, respectively) post PCB versus post uncoated balloon. The PES-ISR1PCB group displayed higher levels of peri-strut inflammation and fibrin scores compared to the -limus DES-ISR + PCB group. Conclusions: In ISR, paclitaxel is primarily deposited in neointimal tissue and effectively retained over time following PCB use. Despite the presence of metallic struts, a uniform distribution was characterized. PCB demonstrated an equivalent biological effect in DES-ISR without significantly increasing inflammation. (C) 2015 Wiley Periodicals, Inc.