Comparison of 2 Paclitaxel-Coated Balloons with Different Excipients for the Treatment of Femoropopliteal Artery Disease: A Randomized Prospective Trial

Abstract

PURPOSE: To evaluate the effectiveness and safety of a novel drug-coated balloon (DCB), Genoss DCB (Genoss), using shellac plus vitamin E as an excipient, compared with a reference DCB using urea. MATERIALS AND METHODS: Patients with femoropopliteal arterial disease under Rutherford Classes 2-5 were enrolled in this prospective, multicenter, noninferiority clinical trial and randomly assigned 1:1 to Genoss DCB and IN.PACT Admiral (Medtronic, Dublin, Ireland). The primary endpoint was late lumen loss at 6 months, which was evaluated using computed tomography (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 losses were -0.08 mm (SD +/- 0.59) in the Genoss DCB group and 0.02 mm (SD +/- 0.72) in the IN.PACT Admiral group (P = .469). The upper limit of the 1-sided 97.5% confidence interval for differences in late lumen loss was 0.17 mm, lower than the noninferiority limit of 0.50 mm, demonstrating the noninferiority of Genoss DCB compared with IN.PACT Admiral. In addition, the 2 groups showed no significant differences in clinically-driven target lesion revascularization, major amputation, and all-cause mortality. CONCLUSIONS: The safety and 6-month late lumen loss of a new DCB using shellac plus vitamin E as excipients were noninferior compared with those of the reference DCB using urea as the excipient.