In Vitro and In Vivo Comparative Evaluation of a Shellac-Ammonium Paclitaxel-Coated Balloon versus a Benchmark Device
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 paclita...
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Wiley
2021-01-01
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| Series: | Journal of Interventional Cardiology |
| Online Access: | http://dx.doi.org/10.1155/2021/9962313 |
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| author | Congying Xia Yunhan Jiang Shuangshuang Li Dan Xiong Xiaojie Chen Yufang Chen |
| author_facet | Congying Xia Yunhan Jiang Shuangshuang Li Dan Xiong Xiaojie Chen Yufang Chen |
| author_sort | Congying Xia |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-71afea5d04334d3cb4371cd8db991d54 |
| institution | Kabale University |
| issn | 0896-4327 1540-8183 |
| language | English |
| publishDate | 2021-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Interventional Cardiology |
| spelling | doaj-art-71afea5d04334d3cb4371cd8db991d542025-08-20T03:33:57ZengWileyJournal of Interventional Cardiology0896-43271540-81832021-01-01202110.1155/2021/99623139962313In Vitro and In Vivo Comparative Evaluation of a Shellac-Ammonium Paclitaxel-Coated Balloon versus a Benchmark DeviceCongying Xia0Yunhan Jiang1Shuangshuang Li2Dan Xiong3Xiaojie Chen4Yufang Chen5Department of Cardiology, West China Hospital of Sichuan University, Chengdu, ChinaDepartment of Cardiovascular Surgery, West China Hospital of Sichuan University, Chengdu, ChinaDepartment of R & D, Cardionovum Co, Ltd, Wuhan, ChinaDepartment of R & D, Cardionovum Co, Ltd, Wuhan, ChinaDepartment of R & D, Cardionovum Co, Ltd, Wuhan, ChinaDepartment of Medical Affair, Cardionovum Co, Ltd, Wuhan, ChinaObjectives. 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.http://dx.doi.org/10.1155/2021/9962313 |
| spellingShingle | Congying Xia Yunhan Jiang Shuangshuang Li Dan Xiong Xiaojie Chen Yufang Chen In Vitro and In Vivo Comparative Evaluation of a Shellac-Ammonium Paclitaxel-Coated Balloon versus a Benchmark Device Journal of Interventional Cardiology |
| title | In Vitro and In Vivo Comparative Evaluation of a Shellac-Ammonium Paclitaxel-Coated Balloon versus a Benchmark Device |
| title_full | In Vitro and In Vivo Comparative Evaluation of a Shellac-Ammonium Paclitaxel-Coated Balloon versus a Benchmark Device |
| title_fullStr | In Vitro and In Vivo Comparative Evaluation of a Shellac-Ammonium Paclitaxel-Coated Balloon versus a Benchmark Device |
| title_full_unstemmed | In Vitro and In Vivo Comparative Evaluation of a Shellac-Ammonium Paclitaxel-Coated Balloon versus a Benchmark Device |
| title_short | In Vitro and In Vivo Comparative Evaluation of a Shellac-Ammonium Paclitaxel-Coated Balloon versus a Benchmark Device |
| title_sort | in vitro and in vivo comparative evaluation of a shellac ammonium paclitaxel coated balloon versus a benchmark device |
| url | http://dx.doi.org/10.1155/2021/9962313 |
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