Comparison of 2 Different Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis: A Randomized Controlled Trial

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Medical Device Technology

Background:

• Drug-coated balloons (DCBs) are effective for treating in-stent restenosis (ISR).
• The Genoss DCB utilizes a novel paclitaxel-eluting formulation with shellac and vitamin E for enhanced drug delivery.
• This excipient combination aims to minimize restenosis by improving drug localization at the target lesion.

Purpose of the Study:

• To evaluate the angiographic efficacy and clinical safety of the Genoss DCB in patients with coronary ISR.
• To compare the Genoss DCB against a reference iopromide-based DCB in a randomized controlled trial.
• To gather data supporting regulatory approval of the Genoss DCB in South Korea.

Main Methods:

• A multicenter, randomized noninferiority trial comparing the Genoss DCB with the SeQuent Please DCB.
• 82 patients with first-time ISR were randomized 1:1 to receive either DCB.
• The primary endpoint was in-segment late lumen loss (LLL) at 6 months, with clinical and angiographic follow-up.

Main Results:

• The Genoss DCB achieved noninferiority for the primary endpoint, with a 6-month in-segment LLL of 0.15 ± 0.43 mm versus 0.24 ± 0.39 mm for the reference device (P for noninferiority = 0.001).
• The upper confidence limit for the difference in LLL was below the noninferiority margin.
• Major adverse cardiovascular events were similar between groups at 6 months (7.7% vs 10.3%, P = 0.692).

Conclusions:

• The novel shellac plus vitamin E-based Genoss DCB is noninferior to the iopromide-based SeQuent Please DCB for treating coronary ISR.
• Both devices demonstrated comparable safety and efficacy profiles at the 6-month follow-up.
• This study provides evidence for the effectiveness of the Genoss DCB in managing coronary ISR.