A Prospective Randomized Trial Comparing 2 Different Paclitaxel-Coated Balloons in De Novo Coronary Artery Disease
Background: The Genoss paclitaxel-coated balloon (PCB) is a novel PCB with shellac and vitamin E as excipients, enhancing drug delivery to the target lesion and minimizing restenosis. Objectives: This study aimed to compare quantitative coronary angiographic outcomes at 6 months after treatment of d...
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Elsevier
2025-01-01
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| Series: | JACC: Asia |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2772374724004721 |
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| author | Eun-Seok Shin, MD, PhD Yongwhi Park, MD, PhD Jong-Young Lee, MD, PhD Ae-Young Her, MD, PhD Min-Ku Chon, MD, PhD Sunwon Kim, MD, PhD Seung-Woon Rha, MD, PhD Gyu Chul Oh, MD, PhD Deok-Kyu Cho, MD, PhD Bitna Kim, MS Jang-Whan Bae, MD, PhD |
| author_facet | Eun-Seok Shin, MD, PhD Yongwhi Park, MD, PhD Jong-Young Lee, MD, PhD Ae-Young Her, MD, PhD Min-Ku Chon, MD, PhD Sunwon Kim, MD, PhD Seung-Woon Rha, MD, PhD Gyu Chul Oh, MD, PhD Deok-Kyu Cho, MD, PhD Bitna Kim, MS Jang-Whan Bae, MD, PhD |
| author_sort | Eun-Seok Shin, MD, PhD |
| collection | DOAJ |
| description | Background: The Genoss paclitaxel-coated balloon (PCB) is a novel PCB with shellac and vitamin E as excipients, enhancing drug delivery to the target lesion and minimizing restenosis. Objectives: This study aimed to compare quantitative coronary angiographic outcomes at 6 months after treatment of de novo coronary artery disease (CAD) with 2 different types of PCBs. Methods: This prospective, multicenter, noninferiority trial randomized 204 patients with chronic coronary syndrome or stabilized acute coronary syndrome to treatment with the shellac and vitamin E-based PCB or the reference PCB (SeQuent Please NEO) in a 1:1 ratio. The primary endpoint was noninferiority for the 6-month angiographic in-lesion late lumen loss. Results: The 6-month in-lesion late lumen loss was 0.06 ± 0.38 mm with shellac and vitamin E-based PCB vs 0.09 ± 0.36 mm with reference PCB. The 1-sided 97.5% upper confidence limit of the difference was 0.08 mm, which was lower than the noninferiority limit of 0.15 mm, achieving noninferiority (P for noninferiority = 0.001). There was comparable late lumen enlargement (44.7% vs 42.7%; P = 0.903) and binary restenosis rates (3.2% vs 6.7%; P = 0.442) following treatment with shellac and vitamin E-based PCB and reference PCB, respectively. Both PCBs had similar 12-month rates of target vessel failure (3.0% in shellac and vitamin E-based PCB vs 4.3% in reference PCB; P = 0.921). Conclusions: The Genoss PCB, formulated with shellac and vitamin E as excipients, demonstrated angiographic outcomes comparable to a clinically proven PCB in the treatment of de novo CAD. (Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Coronary De Novo Lesions; NCT05096442) |
| format | Article |
| id | doaj-art-11ee9c0a0b3d43bfa2634cd9f2703ca5 |
| institution | Kabale University |
| issn | 2772-3747 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Elsevier |
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| series | JACC: Asia |
| spelling | doaj-art-11ee9c0a0b3d43bfa2634cd9f2703ca52025-01-09T06:14:57ZengElsevierJACC: Asia2772-37472025-01-01511524A Prospective Randomized Trial Comparing 2 Different Paclitaxel-Coated Balloons in De Novo Coronary Artery DiseaseEun-Seok Shin, MD, PhD0Yongwhi Park, MD, PhD1Jong-Young Lee, MD, PhD2Ae-Young Her, MD, PhD3Min-Ku Chon, MD, PhD4Sunwon Kim, MD, PhD5Seung-Woon Rha, MD, PhD6Gyu Chul Oh, MD, PhD7Deok-Kyu Cho, MD, PhD8Bitna Kim, MS9Jang-Whan Bae, MD, PhD10Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea; Address for correspondence: Dr Eun-Seok Shin, Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, 877 Bangeojinsunhwan-doro, Dong-gu, Ulsan 44033, South Korea.Department of Internal Medicine, Gyeongsang National University School of Medicine and Cardiovascular Center, South KoreaDivision of Cardiology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South KoreaDivision of Cardiology, Department of Internal Medicine, Kangwon National University College of Medicine, Kangwon National University School of Medicine, Chuncheon, South KoreaDepartment of Internal Medicine, Pusan National University School of Medicine and Cardiovascular Center and Research institute for Convergence of biomedical science and technology, Pusan National University Yangsan Hospital, Yangsan, South KoreaDepartment of Cardiology, Korea University Ansan Hospital, Ansan, South KoreaCardiovascular Center, Korea University Guro Hospital, Seoul, South KoreaCardiovascular Center and Cardiology Division, Seoul St. Mary’s Hospital, The Catholic University of Korea, Seoul, South KoreaYonsei University College of Medicine and Cardiovascular Center, Yongin Severance Hospital, Yongin, South KoreaDepartment of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South KoreaDivision of Cardiology, Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University, College of Medicine, Cheongju, South KoreaBackground: The Genoss paclitaxel-coated balloon (PCB) is a novel PCB with shellac and vitamin E as excipients, enhancing drug delivery to the target lesion and minimizing restenosis. Objectives: This study aimed to compare quantitative coronary angiographic outcomes at 6 months after treatment of de novo coronary artery disease (CAD) with 2 different types of PCBs. Methods: This prospective, multicenter, noninferiority trial randomized 204 patients with chronic coronary syndrome or stabilized acute coronary syndrome to treatment with the shellac and vitamin E-based PCB or the reference PCB (SeQuent Please NEO) in a 1:1 ratio. The primary endpoint was noninferiority for the 6-month angiographic in-lesion late lumen loss. Results: The 6-month in-lesion late lumen loss was 0.06 ± 0.38 mm with shellac and vitamin E-based PCB vs 0.09 ± 0.36 mm with reference PCB. The 1-sided 97.5% upper confidence limit of the difference was 0.08 mm, which was lower than the noninferiority limit of 0.15 mm, achieving noninferiority (P for noninferiority = 0.001). There was comparable late lumen enlargement (44.7% vs 42.7%; P = 0.903) and binary restenosis rates (3.2% vs 6.7%; P = 0.442) following treatment with shellac and vitamin E-based PCB and reference PCB, respectively. Both PCBs had similar 12-month rates of target vessel failure (3.0% in shellac and vitamin E-based PCB vs 4.3% in reference PCB; P = 0.921). Conclusions: The Genoss PCB, formulated with shellac and vitamin E as excipients, demonstrated angiographic outcomes comparable to a clinically proven PCB in the treatment of de novo CAD. (Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Coronary De Novo Lesions; NCT05096442)http://www.sciencedirect.com/science/article/pii/S2772374724004721drug-coated balloonoutcomepaclitaxelpercutaneous coronary interventionrandomized controlled trial |
| spellingShingle | Eun-Seok Shin, MD, PhD Yongwhi Park, MD, PhD Jong-Young Lee, MD, PhD Ae-Young Her, MD, PhD Min-Ku Chon, MD, PhD Sunwon Kim, MD, PhD Seung-Woon Rha, MD, PhD Gyu Chul Oh, MD, PhD Deok-Kyu Cho, MD, PhD Bitna Kim, MS Jang-Whan Bae, MD, PhD A Prospective Randomized Trial Comparing 2 Different Paclitaxel-Coated Balloons in De Novo Coronary Artery Disease JACC: Asia drug-coated balloon outcome paclitaxel percutaneous coronary intervention randomized controlled trial |
| title | A Prospective Randomized Trial Comparing 2 Different Paclitaxel-Coated Balloons in De Novo Coronary Artery Disease |
| title_full | A Prospective Randomized Trial Comparing 2 Different Paclitaxel-Coated Balloons in De Novo Coronary Artery Disease |
| title_fullStr | A Prospective Randomized Trial Comparing 2 Different Paclitaxel-Coated Balloons in De Novo Coronary Artery Disease |
| title_full_unstemmed | A Prospective Randomized Trial Comparing 2 Different Paclitaxel-Coated Balloons in De Novo Coronary Artery Disease |
| title_short | A Prospective Randomized Trial Comparing 2 Different Paclitaxel-Coated Balloons in De Novo Coronary Artery Disease |
| title_sort | prospective randomized trial comparing 2 different paclitaxel coated balloons in de novo coronary artery disease |
| topic | drug-coated balloon outcome paclitaxel percutaneous coronary intervention randomized controlled trial |
| url | http://www.sciencedirect.com/science/article/pii/S2772374724004721 |
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