SFA and ISR Data From BIOLUX P-III Registry Presented for Biotronik's Passeo-18 DCB

October 2, 2018—Biotronik announced that results from the BIOLUX P-III Registry evaluating the company's Passeo-18 Lux drug-coated balloon (DCB) were presented at CIRSE 2018, the Cardiovascular and Interventional Radiological Society of Europe congress held September 22–25 in Lisbon, Portugal. BIOLUX P-III is a large real-world registry composed of 882 patients who were enrolled across 47 study sites. Data presented included the 24-month outcomes of the superficial femoral artery (SFA) subgroup and 12-month results for the in-stent restenosis (ISR) subgroup.

At CIRSE, Prof. Christoph Binkert, MD, presented the data from the SFA subgroup (n = 441). The findings demonstrated 91.7% freedom from clinically driven target lesion revascularization (CD-TLR) and 78% primary patency at 24 months. These outcomes are “particularly noteworthy given the complex patient cohort, with 42% of included lesions classified as moderately or heavily calcified,” stated the company.

In Biotronik's press release, Prof. Binkert commented, “DCBs are now established as an effective treatment for the SFA with low rates of reintervention and good patency at 12 months seen in previously presented data. The goal of any intervention is to maintain good vessel function as long as possible. In BIOLUX P-III, less than 9% of subjects required revascularization at 2 years in a complex patient population, representing a very promising outcome.” Prof. Binkert is from Kantonsspital Winterthur in Winterthur, Switzerland.

Prof. Marianne Brodmann, MD, presented the ISR subgroup of treatment of infrainguinal arteries (n = 103), including SFA, popliteal, and below-the-knee lesions. The 12-month data showed 90.1% freedom from CD-TLR and 77.3% primary patency, with 88.8% of patients without any major adverse events.

Prof. Brodmann commented, “You can’t treat ISR like a de novo lesion—naturally, the presence of a stent from a previous intervention complicates the procedure. In these cases, a DCB is an important treatment option to minimize the burden on the vessel. These results show that we can treat ISR effectively while leaving nothing behind.” Prof. Brodmann is from Medical University of Graz in Graz, Austria.