Results From the World’s Second Largest All-Comers Drug-Coated Balloon Registry Show Continuing Benefit of Passeo-18 Lux in Patients with Critical Limb Ischemia and Diabetes with Positive Outcomes in Terms of Patient Safety

LEIPZIG, Germany and BUELACH, Switzerland, February 12, 2019 – Data from the BIOLUX P-III All-Comers Registry presented at LINC 2019 highlighted the safety and efficacy of BIOTRONIK’s Passeo-18 Lux* drug-coated balloon (DCB), even in challenging patient subgroups. A number of presentations during LINC congress focused on the 24-month results of the all-comers DCB registry, covering aspects such as mortality rates and subgroup analyses of patients with critical limb ischemia (CLI) and diabetes.

During a session dedicated to new data on peripheral DCBs and stents, Prof. Gunnar Tepe, Institute of Radiology, Rosenheim, Germany, presented the 24-month full-cohort data from the BIOLUX P-III registry. The full cohort comprises of 882 enrolled patients. The data reports 88.8% of freedom from clinically-driven target lesion revascularization (fcd-TLR)¹. The full cohort of the registry included patients with highly advanced disease states, of which 42.1% were diagnosed as CLI and almost 20% with below-the-knee (BTK) lesions1. Despite the high amount of BTK and complex lesions (32.6% TASC C and D), the major target limb amputation rate remained very low at 7.3% at two years¹.

Mortality Rates in the Spotlight

Following concerns regarding the mortality rates of paclitaxel-coated devices recently raised by Katsanos et al. in a meta-analysis², Prof. Tepe presented available mortality data for Passeo-18 Lux during his presentation. An evaluation and analysis of the Passeo-18 Lux clinical program revealed no difference in mortality at one year between the DCB and control PTA groups in BIOLUX P-I RCT (no death in the DCB arm versus 2/30 in the PTA arm) and P-II (8.3% in the DCB arm versus 5.6% in the PTA arm). In BIOLUX P-III no relationship between the dose of paclitaxel and an increase in mortality was seen. At two years, the BIOLUX P-III registry data for the full cohort of 882 patients showed a crude mortality rate of 10.3%.

Prof. Tepe thus concluded that evaluated patient-level data showed no significant differences in the distribution of causes of death during the first year compared to the second year, and that no dose dependency of the mortality rate in the full cohort was observed.

CLI Subgroup Demonstrates Low Freedom from cd-TLR

Prof. Marianne Brodmann, Medical University of Graz, Austria, presented 24-month results from the largest CLI population enrollment in a real-world all-comer registry. Freedom from major target limb amputation was reported at 85.4% and freedom from cd-TLR at 88.2%. The results also showed a crude mortality rate of 16.2% in the CLI subgroup³.

Diabetes Subgroup Analysis Reveals Strong Results in a Challenging Population

Focusing on a complex population of patients with diabetes, Prof. Johannes B. Dahm, MVZ Herz- und Gefäßzentrum HGZ-Göttingen, Krankenhaus Neu Bethlehem, Göttingen, Germany, presented the results of 460 diabetic subjects from the registry with 53.1% CLI and 23.4% BTK lesions⁴. In this subgroup, Prof. Dahm reported 87.5% freedom from cd-TLR and 87.4% freedom of major target limb amputation at two years⁴.

“The two-year results of the BIOLUX P-III registry further confirm safety and efficacy of Passeo-18 Lux, even in more challenging patient subgroups,” commented Dr. Alexander Uhl, Senior Vice President Corporate Marketing at BIOTRONIK. “BIOTRONIK is committed to supporting the medical community by providing additional data to confirm the long-term safety of paclitaxel-coated balloons. We will therefore extend the follow-up of paclitaxel-coated balloon studies to include long-term five-year patient data retrospectively on randomized control trials (BIOLUX P-I and P-II) and prospectively in the currently running all-comers registry, BIOLUX P-III.”

About Passeo-18 Lux

Passeo-18 Lux is a combination device for treating de novo and restenotic lesions in the infrainguinal arteries. Its design is based on that of the proven Passeo-18 uncoated balloon catheter, combined with the Lux coating containing anti-proliferative paclitaxel and Butyryl-Tri-Hexyl-Citrate, a biocompatible excipient to enable optimal drug transfer to the target lesion. This coating is also applied to Pantera Lux, BIOTRONIK’s clinically proven coronary drug-coated balloon. Passeo-18 Lux features the innovative Safeguard insertion aid, which improves ease of handling and protects the user from contact and balloon coating from damage. After use, the insertion aid can simply be peeled away.

Passeo, Lux, Pantera and SafeGuard are trademarks or registered trademarks of the BIOTRONIK Group of Companies.

References

1. Tepe G. BIOLUX P-III Passeo-18 Lux all-comers registry: 24-month results for the full cohort. Presented at: LINC, Jan 22, 2019; Leipzig, Germany.
2. Journal of the American Heart Association. https://doi.org/10.1161/JAHA.118.011245
3. Brodmann M. Twenty-four months outcomes of patients presenting with critical limb ischemia within the BIOLUX P-III registry – a real-world clinical trial treating atherosclerotic arteries with a paclitaxel covered balloon. Presented at: LINC, Jan 22, 2019; Leipzig, Germany.
4. Dahm J.B. Diabetic patients in a real-world clinical trial treated for peripheral arterial disease with a paclitaxel covered balloon. Presented at: LINC, Jan 22, 2019; Leipzig, Germany.