This article is more than 5 years old. Information may no longer be current.
BIOLUX P-I: Paclitaxel-coated balloon superior to uncoated balloon in femoropopliteal lesions
Results of the BIOLUX P-I trial demonstrate significant improvement in late lumen loss at 6 months with a paclitaxel-coated balloon compared with an uncoated balloon in patients with symptomatic de novo or restenotic femoropopliteal lesions.
The study included 60 patients (mean age, 70 years) from five centers in Europe. Each patient was randomly assigned to a paclitaxel-coated balloon (Passeo-18 Lux, Biotronik) or an uncoated balloon catheter (Passeo-18, Biotronik).
Late lumen loss at 6 months was 0.51 ± 0.72 mm with the paclitaxel-coated balloon vs. 1.04 ± 1 mm with the uncoated balloon (P = .033). Binary restenosis at 6 months also was significantly lower with the paclitaxel-coated balloon (11.5% vs. 34.6%; P = .048).
Clinically driven target lesion revascularization at 12 months was 15.4% with the paclitaxel-coated balloon vs. 41.7% with the uncoated balloon (P = .064) in the intention-to-treat population and 16% vs. 52.9%, respectively, (P = .02) in the as-treated population.
There were no deaths in the paclitaxel-coated balloon group and two in the uncoated balloon group. No incidences of thrombosis or major amputation were reported.
The rate of major adverse events at 12 months was lower with the paclitaxel-coated balloon (19.2% vs. 41.2%; P = .139).
Nearly three-quarters of patients in the paclitaxel-coated balloon group (72%) experienced improvement in at least one Rutherford category compared with 65.2% of the uncoated balloon group (P = .846)
“In this first-in-human trial, the Passeo-18 Lux DCB has proven to be safe and effective in patients with femoropopliteal lesions,” the researchers concluded. “Results are consistent with those of other [drug-coated balloons] used in this indication and superior to outcomes achieved with the Passeo-18 uncoated balloon.” – by Rob Volansky
Disclosure: The study was sponsored by Biotronik. Several researchers report consulting for and receiving fees/honoraria from Biotronik.