Objectives. The present study was designed to compare the characteristics and performance regarding drug delivery of a novel drug-coated balloon (DCB) to a benchmark device (Restore® versus SeQuent® Please) in an in vitro and in vivo model. Background. Although Restore® and SeQuent® are both paclitaxel-coated, they use different coating excipient, shellac-ammonium salt and iopromide, respectively. Preclinical study comparing these two different commercial DCBs regarding their characteristics and effects on early vascular response is sparse. Methods. Restore® and SeQuent® DCBs were scanned with electron microscopy for surface characteristic assessment. Both DCBs were transported in an in vitro vessel model for the evaluation of drug wash-off rate and particulate formation. Eighteen coronary angioplasties with either Restore® or SeQuent® DCBs were conducted in 6 swine (three coronary vessels each). Histopathological images of each vessel were evaluated for vessel injury. Results. The surface of Restore® DCB was smooth and evenly distributed with hardly visible crystal, while SeQuent® DCB showed a rougher surface with relatively larger apparent crystals. Restore® DCB had a lower drug wash-off rate and fewer large visible particles, compared to the SeQuent® DCB. No significant difference in mean injure score was found between Restore® and SeQuent® group. Conclusion. Our results suggest that Restore® is better in preclinical performance regarding less release of particles and lower drug wash-off rate as compared to SeQuent® Please. The Restore® DCB, using stable amorphous coating and shellac-ammonium salt as an excipient, appears to provide an advantage in drug delivery efficacy; however, further clinical studies are warranted.

中文翻译：

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虫胶-铵紫杉醇涂层球囊与基准装置的体外和体内比较评估

目标。本研究旨在在体外和体内模型中比较新型药物涂层球囊 (DCB) 与基准装置（Restore® 与 SeQuent® Please）的药物输送特性和性能。背景。虽然 Restore® 和 SeQuent® 都是紫杉醇包衣的，但它们分别使用不同的包衣赋形剂、虫胶铵盐和碘普罗胺。比较这两种不同商业 DCB 的特征和对早期血管反应的影响的临床前研究很少。方法. 用电子显微镜扫描Restore® 和SeQuent® DCB 以评估表面特性。两种 DCB 均在体外容器模型中运输，用于评估药物洗去率​​和颗粒形成。用Restore® 或SeQuent® DCB 对6 头猪（每头3 支冠状血管）进行了18 次冠状动脉血管成形术。评估每条血管的组织病理学图像是否有血管损伤。结果。Restore® DCB 的表面光滑且分布均匀，几乎看不到晶体，而 SeQuent® DCB 的表面较粗糙，表观晶体相对较大。与 SeQuent® DCB 相比，Restore® DCB 具有较低的药物洗去率​​和较少的可见大颗粒。Restore® 和 SeQuent® 组的平均损伤评分没有显着差异。结论。我们的结果表明，与 SeQuent® Please 相比，Restore® 在减少颗粒释放和降低药物洗脱率方面具有更好的临床前性能。Restore® DCB 使用稳定的无定形包衣和虫胶铵盐作为赋形剂，似乎在药物输送功效方面具有优势；然而，需要进一步的临床研究。