A new polymer concept for coating of vascular stents using PTFEP (poly(bis(trifluoroethoxy)phosphazene) to reduce thrombogenicity and late in-stent stenosis
A new polymer concept for coating of vascular stents using PTFEP (poly(bis(trifluoroethoxy)phosphazene) to reduce thrombogenicity and late in-stent stenosis
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DOI：
10.1097/01.rli.0000156195.74967.47
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发表时间：
2005-04-01
影响因子：
6.7
通讯作者：
Grunze, M
中科院分区：
文献类型：
--
作者：
Richter, GM;Stampfl, U;Grunze, M
目的：我们试图评估新的聚合物PTFEP（聚-双（三氟乙氧基）磷腈）的（1）其降低血栓形成性和晚期支架内狭窄的能力和（2）其对兔髂动脉模型中内皮化的作用。纳米涂层在30只新西兰白色兔的髂动脉中植入直径为50 nm（类似于50 nm）和裸不锈钢支架结果：30只兔中，27只成功置入双侧支架，术后1、4、8、12、16周随访，血管造影、光镜、扫描电镜观察结果。27枚涂层支架均未发生血栓沉积，但27枚裸支架中有4枚发生血栓沉积（P = 0.037）。22枚有再狭窄风险的涂层支架中有18枚（随访>= 4周）血管造影正常，而22枚裸支架中只有13枚（P = 0.023）。6枚裸支架出现明显再狭窄（管腔丢失> 30%）（P = 0.011），但所有涂层支架均未出现再狭窄。涂层支架的新生内膜为47.7-73.9 μ m，裸支架为66.9-115.2 μ m（在4、8和16周时具有统计学显著性）。扫描电子显微镜检测到完全内皮化的所有支架从4周（22支架在两组）。结论：PTFEP纳米涂层成功地表现出抗血栓性和减少晚期支架内狭窄。两种支架类型的内皮化程度相同。鼓励在更类似人类的模型和人类动脉中的人类可行性研究中进行研究。
Objectives: We sought to evaluate the new polymer PTFEP (poly-bis(trifluoroethoxy)phosphazene) for (1) its ability to reduce thrombogenicity and late in-stent stenosis and (2) its effect on endothelialization in a rabbit iliac artery model.Materials and Methods: Nanocoated (similar to 50 nm) and bare stainless-steel stents were implanted bilaterally in the iliac arteries of 30 New Zealand White rabbits (1, 4, 8, 12, and 16 weeks follow-up) and evaluated by angiography, light, and scanning electron microscopy.Results: Bilateral stent placement was successful in 27 of 30 rabbits. Thrombus depositions occurred in none of the 27 coated but in 4 of the 27 bare stents (P = 0.037). A normal angiogram was obtained in 18 of 22 coated stents at risk for restenosis (follow-up >= 4 weeks) but only in 13 of 22 bare stents (P = 0.023). Marked restenosis (luminal loss > 30%) was found in 6 bare stents (P = 0.011) but not in any coated stents. The neointima was 47.7-73.9 mu m on coated and 66.9-115.2 mu m on bare stents (statistically significant at 4, 8, and 16 weeks). Scanning electron microscopy detected full endothelialization in all stents from 4 weeks on (22 stents in both groups).Conclusion: PTFEP nanocoating successfully showed thromboresistance and reduced late in-stent stenosis. Endothelialization was equal in both stent types. Studies in more human-like models and human feasibility studies in human arteries are encouraged.