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

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 lo

SUBMITTER: Shin ES 

PROVIDER: S-EPMC11775799 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature