Background

Flow diverters (FDs) are widely used in the treatment of intracranial aneurysms, but the required medication increases the risk of haemorrhagic complications and limits their use in the acute setting. Surface modified FDs may limit the need for dual antiplatelet therapy (DAPT). Hydrophilic polymer coating (HPC) may reduce the need of medication.

Methods

This explorative study, approved by the local authorities and the local welfare committee, compared stent behaviour and overall tissue response between HPC-coated FDs and uncoated FDs, both implanted into the common carotid arteries of eight New Zealand white rabbits. Endothelialisation, inflammatory response, and performance during implantation were assessed. Angiographic follow-up was performed to observe the patency of the devices after implantation and after 30 days. Histological examinations were performed at 30 days to assess foreign body reaction and endothelialisation. Kruskal-Wallis and Wilcoxon tests were used to compare non-parametric variables.

Results

Angiography showed that both coated and uncoated FDs performed well during implantation. All devices remained patent during immediate follow-up and after 30 days. Histopathology showed no significant difference in inflammation within the vessel wall between the two cohorts (2.12 ± 0.75 vs. 1.96 ± 0.79, p = 0.7072). Complete endothelialisation of the stent struts was seen with very similar (0.04 ± 0.02 mm vs. 0.04 ± 0.03 mm, p = 0.892) neoendothelial thickness between the two cohorts after 30 days.

Conclusion

Taking into account the limitation in sample size, non-significant differences between the HPC-coated and uncoated FDs regarding implantation, foreign body response, and endothelialisation were found.

中文翻译：

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与兔颈动脉模型中的未涂层器械相比，评估对HPC涂层p48分流器支架的组织反应的前瞻性研究。

背景

分流器（FDs）被广泛用于颅内动脉瘤的治疗，但是所需的药物增加了出血并发症的风险，并限制了其在急性环境中的使用。表面修饰的FD可能会限制对双重抗血小板治疗（DAPT）的需求。亲水性聚合物涂层（HPC）可以减少药物需求。

方法

由地方当局和当地福利委员会批准的这项探索性研究比较了HPC涂层FD和未涂层FD之间的支架行为和整体组织反应，两者均植入了八只新西兰白兔的颈总动脉中。评估内皮化，炎症反应和植入过程中的表现。进行血管造影随访，以观察植入后和30天后装置的通畅性。在第30天进行组织学检查，以评估异物反应和内皮化。使用Kruskal-Wallis和Wilcoxon检验比较非参数变量。

结果

血管造影显示，包被和未包被的FD在植入过程中均表现良好。在立即随访期间和30天后，所有设备均保持专利权。组织病理学显示两个队列之间的血管壁内炎症无显着差异（2.12±0.75对1.96±0.79，p  = 0.7072）。 30天后，两个队列之间的新内皮厚度非常相似（0.04±0.02 mm对0.04±0.03 mm，p = 0.892），可见支架撑杆完全内皮化。

结论

考虑到样本量的限制，发现HPC涂层的FD和未涂层的FD在植入，异物反应和内皮化方面无显着差异。