A Prospective Randomized Trial Comparing 2 Different Paclitaxel-Coated Balloons in De Novo Coronary Artery Disease
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
Affiliations
Eun-Seok Shin, MD, PhD
Department 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.
Yongwhi Park, MD, PhD
Department of Internal Medicine, Gyeongsang National University School of Medicine and Cardiovascular Center, South Korea
Jong-Young Lee, MD, PhD
Division of Cardiology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea
Ae-Young Her, MD, PhD
Division of Cardiology, Department of Internal Medicine, Kangwon National University College of Medicine, Kangwon National University School of Medicine, Chuncheon, South Korea
Min-Ku Chon, MD, PhD
Department 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 Korea
Sunwon Kim, MD, PhD
Department of Cardiology, Korea University Ansan Hospital, Ansan, South Korea
Seung-Woon Rha, MD, PhD
Cardiovascular Center, Korea University Guro Hospital, Seoul, South Korea
Gyu Chul Oh, MD, PhD
Cardiovascular Center and Cardiology Division, Seoul St. Mary’s Hospital, The Catholic University of Korea, Seoul, South Korea
Deok-Kyu Cho, MD, PhD
Yonsei University College of Medicine and Cardiovascular Center, Yongin Severance Hospital, Yongin, South Korea
Bitna Kim, MS
Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea
Jang-Whan Bae, MD, PhD
Division of Cardiology, Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University, College of Medicine, Cheongju, South Korea
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)
