Comparison of Two Paclitaxel-Coated Balloons with Different Excipients for the Treatment of Femoropopliteal Artery Disease.

Abstract

Purpose: To evaluate the efficacy and safety of a novel drug-coated balloon (DCB), Genoss DCB (Genoss) using shellac plus vitamin E as an excipient, compared to a reference DCB using urea.

Materials and methods: Patients with femoropopliteal arterial disease under Rutherford classes 2-5 were enrolled in this prospective, multicenter, non-inferiority clinical trial, and randomly assigned 1:1 to Genoss DCB and IN.PACT Admiral (Medtronic). The primary endpoint was late lumen loss at 6 months, which was evaluated using CT angiography by an independent investigator blinded to the treatment assignment.

Results: A total of 119 patients from 10 institutions in the Republic of Korea were assigned to the Genoss DCB (N = 59) and IN.PACT Admiral (N = 60) groups. The late lumen loss was -0.08 ± 0.59 mm in the Genoss DCB group and 0.02 ± 0.72 mm in the IN.PACT Admiral group (P = 0.469). The upper limit of the one-sided 97.5% confidence interval for differences in late lumen loss was 0.17 mm, lower than the non-inferiority limit of 0.50 mm, demonstrating the non-inferiority of Genoss DCB as compared to IN.PACT Admiral. In addition, the two groups showed no significant differences in clinically driven target lesion revascularization, major amputation, and all-cause mortality.

Conclusion: In this prospective, randomized trial, the safety and 6-month late lumen loss of a new DCB using shellac plus vitamin E as excipients was non-inferior compared with the reference DCB using urea as the excipient.