Sirolimus-eluting biodegradable poly-L-lactide stent for peripheral vascular application:: A preliminary study in porcine carotid arteries
Sirolimus-eluting biodegradable poly-L-lactide stent for peripheral vascular application:: A preliminary study in porcine carotid arteries
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DOI：
10.1016/j.jss.2006.07.035
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发表时间：
2007-05-01
影响因子：
2.2
通讯作者：
Schareck, Wolfgang
中科院分区：
文献类型：
--
作者：
Buenger, Carsten Michael;Grabow, Niels;Schareck, Wolfgang
背景：评估一种新型西罗莫司（SIR）洗脱可生物降解聚-L-乳酸（PLLA）支架用于外周血管应用的技术可行性和生物相容性。
材料与方法：在15头猪中，双侧颈总动脉（CCA）均经手术暴露并在近端节段夹闭。横向切开后，将12个316L支架、12个未载药以及6个载有西罗莫司的PLLA支架安装在6.0×40 -mm球囊导管上，随机植入CCA并充压至8巴。未使用血管造影设备。在1周（6头猪；316L与PLLA对比）和6周（9头猪；316L与PLLA与西罗莫司 - PLLA对比）后取出植入支架的CCA，并进行定量组织形态计量学处理以及血管炎症和损伤评分评估。
结果：随访期间无动物死亡。所有支架在组织学分析中均通畅，无任何过度回缩或塌陷的迹象。与316L支架相比，未载药的PLLA支架在1周（残余管腔面积13.16±0.34，新生内膜面积1.94±0.26）和6周（残余管腔面积11.57±0.30，新生内膜面积2.85±0.24）时，残余管腔面积减小，新生内膜面积增加，而316L支架在1周时为（15.26±0.13，1.27±0.41），6周时为（13.99±0.51，1.54±0.59）。西罗莫司洗脱支架在6周时显示出与316L支架相当的新生内膜面积（1.75±0.38），内膜厚度降低50%，但由于支架丝厚度不同（PLLA为270μm；316L为155μm），残余管腔略减小（13.06±0.32）。西罗莫司可降低针对PLLA支架的血管炎症评分。所有组的血管损伤评分均较低且相似。
结论：PLLA支架在猪颈总动脉支架植入后显示出足够的机械稳定性。通过加入西罗莫司，观察到对PLLA支架的炎症和新生内膜反应显著降低，且无全身毒性或血栓并发症。这些发现需要更长时间的随访来评估以确认疗效的维持。PLLA支架较大的支架丝高度是一个主要限制，需要改进。（c）2007爱思唯尔公司。保留所有权利。
Background. To assess technical feasibility and biocompatibility of a new Sirolimus (SIIR.)-eluting biodegradable poly-L-lactide (PLIA) stent for peripheral vascular application.Material and methods. In 15 pigs,, both common carotid arteries (CCA) were surgically exposed and clamped in the proximal segment. After transverse incision, 12 316L stents, 12 unloaded and 6 SIR-loaded PLLA stents mounted on 6.0 X 40-mm balloon catheters were randomly implanted into the CCA and inflated to 8 bar. Angiographic equipment was not available. Stented CCA were explanted after 1 week (6 pigs; 316L versus PLIA) and 6 weeks (9 pigs; 316L versus PLIA versus SIR-PLIA), and processed for quantitative histomorphometry and estimation of vascular inflammation and injury scores.Results. No animals were lost during follow-up. All stents were patent on histological analysis without any signs of excessive recoiling or collapse. Unloaded PLLA stents showed decreased residual lumen area and increased neointimal area after 1 week (13.16 +/- 0.34, 1.94 +/- 0.26) and 6 weeks (11.57 +/- 0.30, 2.85 +/- 0.24) as compared with 316L stents (15.26 +/- 0.13, 1.27 +/- 0.41 and 13.99 +/- 0.51, 1.54 +/- 0.59). SIR-eluting stents demonstrated comparable neointimal area (1.75 +/- 0.38) and 50% lower intimal thickness as compared with 316L stents after 6 weeks, but a slightly decreased residual lumen (13.06 +/- 0.32) in the consequence of differences in strut thickness (PLLA, 270 mu m; 316L, 155 mu m). The vascular inflammation score against PLLA-stents could be reduced by Sirolimus. The vascular injury scores were low and similar in all groups.Conclusions. PLIA stents showed sufficient mechanical stability after porcine CCA stenting. By incorporation of Sirolimus, a significant reduction of the inflammatory and neointimal response to the PLIA stent was seen without systemic toxicity or thrombotic complications. These findings need to be assessed with longer follow-up to confirm maintenance of efficacy. The greater strut height of PLLA stents is a major limitation and requires modification. (c) 2007 Elsevier Inc. All rights reserved.