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. 2025 Jan 7;5(1):15-24.
doi: 10.1016/j.jacasi.2024.10.028. eCollection 2025 Jan.

A Prospective Randomized Trial Comparing 2 Different Paclitaxel-Coated Balloons in De Novo Coronary Artery Disease

Eun-Seok Shin  1 , Yongwhi Park  2 , Jong-Young Lee  3 , Ae-Young Her  4 , Min-Ku Chon  5 , Sunwon Kim  6 , Seung-Woon Rha  7 , Gyu Chul Oh  8 , Deok-Kyu Cho  9 , Bitna Kim  1 , Jang-Whan Bae  10
Affiliations

A Prospective Randomized Trial Comparing 2 Different Paclitaxel-Coated Balloons in De Novo Coronary Artery Disease

Eun-Seok Shin et al. JACC Asia. .

Abstract

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).

Keywords: drug-coated balloon; outcome; paclitaxel; percutaneous coronary intervention; randomized controlled trial.

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Conflict of interest statement

This study was supported by the unrestricted research fund from GENOSS Co Ltd (Suwon, South Korea) through an institutional research grant. The executive committee, together with the sponsor, designed the clinical trial. The sponsor had no role in data collection, data analysis, data interpretation, writing the manuscript, or the decision to submit the manuscript for publication. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Figures

None
Graphical abstract
Figure 1
Figure 1
Flow Chart of the Study From September 30, 2021, to November 14, 2022, 204 patients with de novo coronary artery disease were randomly assigned to either the shellac plus vitamin E-based paclitaxel-coated balloon (PCB) (n = 102) or the iopromide-based PCB (n = 102) treatment group.
Figure 2
Figure 2
Cumulative Frequency Distribution of Minimal Lumen Diameter and Diameter Stenosis Cumulative frequency distribution curve of (A) minimal lumen diameter and (B) diameter stenosis, respectively. The cumulative frequency distributions of in-lesion minimal lumen diameter and percent diameter stenosis show comparable results between the 2 groups. PCB = paclitaxel-coated balloon.
Figure 3
Figure 3
Cumulative Frequency Distribution of In-Lesion Lumen Loss and Lumen Gain Cumulative frequency distribution curve of (A) late lumen loss and (B) net lumen gain, respectively. The cumulative frequency distribution curves of late lumen loss and net lumen gain show comparable results between the 2 groups. PCB = paclitaxel-coated balloon.
Central Illustration
Central Illustration
A Prospective, Randomized Multicenter, Noninferiority Trial in De Novo CAD The 6-month in-lesion late lumen loss was 0.06 ± 0.38 mm with shellac plus vitamin E-based paclitaxel-coated balloon (PCB) (Genoss PCB) vs 0.09 ± 0.36 mm with reference PCB (SeQuent Please NEO). The 1-sided 97.5% upper confidence limit of the difference was 0.08 mm, lower than the noninferiority limit of 0.15 mm, achieving noninferiority (P for noninferiority = 0.001). CAD = coronary artery disease.
See this image and copyright information in PMC

References

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