Comparison of 2 Different Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis: A Randomized Controlled Trialopen access
- Authors
- Jun, E.J.; Shin, E.-S.; Yuan, S.L.; Bhak, Y.; Garg, S.; Kang, W.C.; Kim, J.S.; Kim, J.-H.; Bae, J.-W.; Rha, S.-W.; Chae, I.-H.
- Issue Date
- Apr-2022
- Publisher
- Elsevier Inc.
- Keywords
- cardiovascular events; drug-coated balloon; in-segment late lumen loss; major adverse
- Citation
- JACC: Asia, v.2, no.2, pp.170 - 179
- Journal Title
- JACC: Asia
- Volume
- 2
- Number
- 2
- Start Page
- 170
- End Page
- 179
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/84809
- DOI
- 10.1016/j.jacasi.2021.11.015
- ISSN
- 2772-3747
- 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
- Files in This Item
- There are no files associated with this item.
- Appears in
Collections - 의과대학 > 의학과 > 1. Journal Articles
![qrcode](https://api.qrserver.com/v1/create-qr-code/?size=55x55&data=https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/84809)
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.