Comparison of 2 Different Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis: A Randomized Controlled Trial
DC Field | Value | Language |
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dc.contributor.author | Jun, E.J. | - |
dc.contributor.author | Shin, E.-S. | - |
dc.contributor.author | Yuan, S.L. | - |
dc.contributor.author | Bhak, Y. | - |
dc.contributor.author | Garg, S. | - |
dc.contributor.author | Kang, W.C. | - |
dc.contributor.author | Kim, J.S. | - |
dc.contributor.author | Kim, J.-H. | - |
dc.contributor.author | Bae, J.-W. | - |
dc.contributor.author | Rha, S.-W. | - |
dc.contributor.author | Chae, I.-H. | - |
dc.date.accessioned | 2022-06-26T09:40:07Z | - |
dc.date.available | 2022-06-26T09:40:07Z | - |
dc.date.created | 2022-06-26 | - |
dc.date.issued | 2022-04 | - |
dc.identifier.issn | 2772-3747 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/84809 | - |
dc.description.abstract | Background: Drug-coated balloons (DCBs) offer an effective treatment for in-stent restenosis (ISR). The Genoss DCB is a novel paclitaxel-coated balloon with a shellac plus vitamin E excipient that enhances drug delivery to the target lesion, minimizing restenosis. Objectives: This study aimed to investigate the angiographic efficacy, clinical safety, and effectiveness of the novel shellac plus vitamin E–based DCB in a randomized controlled trial designed to enable regulatory approval of this new device in South Korea. Methods: This noninferiority trial randomized patients experiencing their first ISR to the novel shellac plus vitamin E–based DCB or the reference SeQuent Please iopromide-based DCB in a 1:1 ratio. All patients underwent planned angiographic and clinical follow-up at 6 months. The study was powered for the primary endpoint of 6 months in-segment late lumen loss (LLL). Results: A total of 82 patients from 7 centers were randomized to either the novel shellac plus vitamin E–based DCB group (n = 41) or the reference iopromide-based DCB group (n = 41). The 6-month in-segment LLL was 0.15 ± 0.43 mm with the novel DCB compared with 0.24 ± 0.39 mm with the reference device. The 1-sided 97.5% upper confidence limit of the difference was 0.13 mm, lower than the noninferiority limit of 0.29 mm, achieving noninferiority (P for noninferiority = 0.001). Major cardiovascular events were comparable between 2 groups at 6 months (7.7% for the novel DCB vs 10.3% for the reference DCB; P = 0.692). Conclusions: In this multicenter, head-to-head comparison randomized trial, the novel shellac plus vitamin E–based DCB showed a comparable result to the reference iopromide-based device for the primary endpoint of 6-month in-segment LLL for the treatment of coronary ISR. (Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please in Korean Patient With Coronary In-stent Restenosis; NCT04405063) © 2022 The Authors | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | Elsevier Inc. | - |
dc.relation.isPartOf | JACC: Asia | - |
dc.title | Comparison of 2 Different Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis: A Randomized Controlled Trial | - |
dc.type | Article | - |
dc.type.rims | ART | - |
dc.description.journalClass | 1 | - |
dc.identifier.doi | 10.1016/j.jacasi.2021.11.015 | - |
dc.identifier.bibliographicCitation | JACC: Asia, v.2, no.2, pp.170 - 179 | - |
dc.description.isOpenAccess | Y | - |
dc.identifier.scopusid | 2-s2.0-85132193295 | - |
dc.citation.endPage | 179 | - |
dc.citation.startPage | 170 | - |
dc.citation.title | JACC: Asia | - |
dc.citation.volume | 2 | - |
dc.citation.number | 2 | - |
dc.contributor.affiliatedAuthor | Kang, W.C. | - |
dc.type.docType | Article | - |
dc.subject.keywordAuthor | cardiovascular events | - |
dc.subject.keywordAuthor | drug-coated balloon | - |
dc.subject.keywordAuthor | in-segment late lumen loss | - |
dc.subject.keywordAuthor | major adverse | - |
dc.description.journalRegisteredClass | scopus | - |
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