A novel paclitaxel-eluting porous carbon-carbon nanoparticle coated, nonpolymeric cobalt-chromium stent: Evaluation in a porcine model

A novel paclitaxel-eluting porous carbon-carbon nanoparticle coated, nonpolymeric cobalt-chromium stent: Evaluation in a porcine model
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DOI:
10.1002/ccd.20698
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发表时间:
2006-05-01
影响因子:
2.3
通讯作者:
Somaraju, B
Somaraju, B
中科院分区:
医学3区
文献类型:
--
作者:
Bhargava, B;Reddy, NK;Somaraju, B

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目的:我们旨在评价猪冠状动脉对新型紫杉醇洗脱多孔碳-碳纳米颗粒涂层非聚合物钴铬支架的反应。背景:聚合物药物洗脱支架可显著降低再狭窄。然而,聚合物的无限期存在被认为会引发和维持炎症,并导致晚期并发症的发生。研究方法:在猪冠状动脉中植入了16枚碳-碳涂层、非聚合物钴铬合金支架,其中植入了两种不同剂量的紫杉醇(每种8枚)。此外,还研究了8个涂有可生物降解聚合物的钴铬支架。支架植入后6周处死动物,进行组织形态学分析。比较三组支架的结果。结果如下:与Cypher支架的历史数据相比,碳-碳涂层的钴铬合金支架(含低剂量和中等剂量紫杉醇)在内皮化、新生内膜增生、直径狭窄百分比、炎症反应和纤维蛋白沉积倾向方面均表现出可接受的性能特征。另一方面,涂有聚(丙交酯)和聚(丙交酯-co-乙交酯)生物可降解聚合物和0.7 μ g/mm(2)紫杉醇的支架表现出较差的性能。内皮化不良、新生内膜增生、直径狭窄百分比、炎症反应和纤维蛋白沉积倾向有显著趋势(所有参数P < 0.01)。结论:该临床前评价证明了具有碳-碳涂层和低剂量和中等剂量紫杉醇的新型钴铬合金支架的安全性和有效性。(C)2006威利-利斯公司
Objectives: We aimed to evaluate the response of porcine coronary arteries to a novel paclitaxel-eluting porous carbon-carbon nanoparticle coated, nonpolymeric cobalt chromium stent. Background: Polymer based drug-eluting stents significantly reduce restenosis. However, the indefinite presence of polymer is thought to initiate and sustain inflammation and contribute to the occurrence of late complications. Methods: Sixteen carbon-carbon coated, nonpolymeric cobalt chromium stents with two different doses of paclitaxel (eight of each) were implanted in porcine coronary arteries. In addition, eight cobalt chromium stents coated with a biodegradable polymer were also studied. Animals were sacrificed 6 weeks after stent implantation and histomorphometric analysis was performed. Results were compared among the three groups of stents. Results: The cobalt chromium stents coated with carbon-carbon with low and medium doses of paclitaxel both showed acceptable performance characteristics, with respect to endothelialization, neointimal hyperplasia, percentage diameter stenosis, inflammatory response, and tendency to fibrin deposition, when compared to historical data with the Cypher stent. On the other hand, the stents coated with poly(lactide) and poly(lactide-co-glycolide) biodegradable polymers and 0.7 mu g/mm(2) paclitaxel showed poor performance. There was a significant tendency to poor endothelialization, greater neointimal hyperplasia, percentage diameter stenosis, greater inflammatory response, and tendency to fibrin deposition (P < 0.01 for all parameters). Conclusions: This preclinical evaluation demonstrates the safety and efficacy of a novel cobalt chromium stent with a carbon-carbon coating and low and medium doses of paclitaxel. (C) 2006 Wiley-Liss, Inc.