First-in-Man Results Published for Biotronik's Passeo-18 Lux DCB in Infrapopliteal Arteries

October 21, 2015—In the Journal of American College of Cardiology (JACC): Cardiovascular Interventions, Thomas Zeller, MD, et al published findings from the BIOLUX P-II first-in-man study of Biotronik’s Passeo-18 Lux drug-releasing percutaneous transluminal angioplasty (PTA) balloon catheter for the revascularization of infrapopliteal arteries (2015;8:1614–1622). 

Noting that drug-coated balloons (DCB) have shown promising results in femoropopliteal lesions but data for infrapopliteal lesions are scarce, the investigators sought to compare the safety and efficacy of the new Passeo-18 Lux paclitaxel-coated DCB versus the uncoated balloon in PTA treatment of de novo or native restenotic lesions of the infrapopliteal arteries in patients with claudication and critical limb ischemia.

As summarized in JACC: Cardiovascular Interventions, BIOLUX P-II is a prospective, multicenter, randomized first-in-man study that randomized 72 patients to either a Passeo-18 Lux DCB (n = 36) or a Passeo-18 PTA device (n = 36). Follow-up assessments were scheduled at 1, 6, and 12 months, with angiographic assessment at 6 months. Adverse events were adjudicated by an independent clinical events committee, and angiographic parameters were assessed by an independent core laboratory.

The investigators reported that the primary safety endpoint (a composite of all-cause mortality, target extremity major amputation, target lesion thrombosis, and target vessel revascularization at 30 days) was 0% in the DCB group versus 8.3% in the uncoated balloon group. The primary performance endpoint (patency loss at 6 months) was 17.1% in the DCB group versus 26.1% in the uncoated balloon group, and major amputations of the target extremity occurred in 3.3% versus 5.6% of the patients at 12 months, respectively.

The investigators concluded that the Passeo-18 Lux DCB has been proven to be safe and effective in infrapopliteal lesions with comparable outcomes to the uncoated PTA balloon catheter.