Two-Year Outcomes Announced From BIOLUX P-III Registry

February 12, 2019—Biotronik announced 24-month data from the BIOLUX P-III registry, which were first presented at LINC, the Leipzig Interventional Course held January 22–25, 2019, in Leipzig, Germany.

In response to the recent concerns regarding increased mortality rates associated with the use of paclitaxel-coated devices seen in the Katsanos et al meta-analysis, mortality data for the Passeo-18 Lux drug-coated balloon (DCB; Biotronik) were shared as part of a presentation by Professor Gunnar Tepe, MD. At 1 year, no difference in mortality was seen between the DCB and control percutaneous transluminal angioplasty (PTA) groups in the BIOLUX P-I trial (no deaths in the DCB arm vs two deaths in the PTA arm) nor the BIOLUX P-II trial (8.3% in the DCB arm vs 5.6% in the PTA arm).

Furthermore, the BIOLUX P-III registry data showed no relationship between the dose of paclitaxel and an increase in mortality. At 2 years, a crude mortality rate of 10.3% was reported among the full 882-patient cohort.

The full cohort of the registry included patients with highly advanced disease states, including 42.1% with critical limb ischemia (CLI) and nearly 20% with below-the-knee (BTK) lesions. Despite the high prevalence of BTK and complex lesions (32.6% TransAtlantic Inter-Society Consensus C and D), the observed major target limb amputation rate was still very low at 7.3% at 2 years. Furthermore, the rate of freedom from clinically driven target lesion revascularization (CD-TLR) was 88.8%.

Also at LINC, Professor Marianne Brodmann, MD, who is with the Medical University of Graz in Graz, Austria, presented 24-month results from a CLI subgroup of the BIOLUX P-III registry, which included the largest CLI population studied in a real-world, all-comers registry. The results showed freedom from major target limb amputation rate of 85.4% and freedom from CD-TLR rate of 88.2%. The crude mortality rate was 16.2% in this CLI subgroup.

Finally, data from another subgroup analysis of patients with diabetes were presented by Professor Johannes B. Dahm, MD, who is Director of Interventional Cardiology and Angiology at the Heart & Vascular Center Neu Bethlehem in Göttingen, Germany. This cohort included 460 registry patients who had diabetes, as well as 53.1% who had CLI and 23.4% with BTK lesions. In this subgroup, Prof. Dahm reported 87.5% freedom from CD-TLR and 87.4% freedom from major target limb amputation at 2 years.