In Vitro and In Vivo Comparative Evaluation of a Shellac-Ammonium Paclitaxel-Coated Balloon versus a Benchmark Device. (26th May 2021)

• Record Type: Journal Article
• Authors: Xia, Congying; Jiang, Yunhan; Li, Shuangshuang; Xiong, Dan; Chen, Xiaojie; Chen, Yufang
• Other Names: Dens Joseph Academic Editor.
• Is Part Of: Journal of interventional cardiology. Volume 2021(2021)
• Publication Date: 2021-05-26
• Subjects: Cardiology -- Periodicals; Heart -- Diseases -- Periodicals; 616.1206
• DOI: 10.1155/2021/9962313
• Languages: English
• ISSNs: 0896-4327

Abstract

Abstract : 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.