Charing Cross 2019: Two-Year-Data of World’s Second Largest All-Comers DCB Registry Supports Safety of Passeo-18 Lux

BIOLUX P-III 24-month study data supports safe and effective clinical performance of the Passeo^®-18 Lux^TM drug-coated balloon (DCB) for patients with infrapopliteal artery lesions and in-stent restenosis (ISR). The full BIOLUX P-III study cohort comprises of 882 enrolled patients.

BIOLUX P-III BTK Subgroup 24-Month Data Shows Encouraging Safety and Efficacy Results

Prof. Gunnar Tepe, Institute of Radiology, Rosenheim, Germany, presented the 24-month clinical outcomes for patients with infrapopliteal artery lesions¹ at the Charing Cross Symposium. 151 patients with a total of 185 below-the-knee (BTK) lesions were treated with BIOTRONIK’s Passeo-18 Lux DCB. At 24 months the data demonstrated a major adverse events (MAE) rate² of 20.3% and freedom from clinically-driven target lesion revascularization (CD-TLR) in 91.4%. Freedom from major target limb amputation was 90.4%.

“The outcomes support Passeo-18 Lux as a valuable treatment option for the infrapopliteal arteries,” concluded Prof. Tepe. “With ongoing discussions regarding Paclitaxel use, we are looking forward to the long-term outcomes up to five years.”

Sustained Good Clinical Outcomes in BIOLUX P-III Patients With In-Stent Restenosis

24-month results of patients treated for ISR were presented by Prof. Marianne Brodmann, Angiology department at the Medical University in Graz, Austria. The reported MAE rate for 103 patients was 27.3% while 78.6% of lesions were free from CD-TLR³. In a separate presentation, Prof. Brodmann also presented a sub-analysis focused on patients with lesions that required implantation of a bare metal stent (BMS) after DCB (bail-out stent group) compared to patients where only DCB was used. Similar outcomes for both primary endpoints were achieved, even though the bail-out stent group included more complex lesions, presenting 31.3% TASC C and D lesions compared to 14.6% in the DCB only group⁴. Prof. Brodmann concluded that a combination of Passeo-18 Lux and BMS is an effective way to treat long, heavily calcified or occluded lesions.

“Even in these more challenging patient subgroups, we see the safety and efficacy of Passeo-18 Lux confirmed by the BIOLUX P-III registry data,” commented Dr. Alexander Uhl, Senior Vice President Corporate Marketing at BIOTRONIK. “Given the current Paclitaxel debate, we at BIOTRONIK will continue to ensure long term follow-ups and accurate patient safety data collection. By extending the follow-up of our Passeo-18 Lux studies to five years, we’re contributing to the evidence base on the long-term safety of paclitaxel-coated balloons.”

First In-Human Data Analysis: Is a Higher Chronic Outward Force a Significant Risk Factor for Restenosis?

Dr. Mark Burket, Toledo, Ohio, USA presented a detailed analysis of the Pulsar^®-18 and Astron^® Pulsar self-expanding stent chronic outward force (COF) in the BIOFLEX-I IDE trial femoro-popliteal patient cohort. This first in-human clinical data in the USA presents a trend that a high COF is linked to an increased restenosis rate in the superficial femoral artery (SFA) at 12 months⁵. Dr. Burket pointed out that according to the analysis a lower COF results in less restenosis and potentially less re-interventions.

References

^{1. Tepe G. Patients with infrapopliteal artery lesions treated with a paclitaxel covered balloon in a real-world clinical trial. Twenty four-month results of the BIOLUX P-III All Comers Registry. Presented at: Charing Cross 2019; April 16, 2019; London, United Kingdom.}

^{2. Freedom from major adverse events (MAE) was defined as a composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and clinically driven target lesion revascularization (TLR) within 6 months post-index procedure.}

^{3. Brodmann M. Twenty four-month results of instent restenosis patients treated with a paclitaxel covered balloon in the real-world BIOLUX P-III All-comers Registry. Presented at: Charing Cross 2019; April 18, 2019; London, United Kingdom.}

^{4. Brodmann M. DCB only vs Bail-out stented outcomes at 24-months, a sub-analysis of BIOLUX P-III global Passeo-18 Lux registry. Presented at: Charing Cross 2019; April 16, 2019; London, United Kingdom.}

^{5. Burket M. High outward force of self-expanding BMS in SFA could be a significant risk factor for restenosis at 12 month. Presented at: Charing Cross 2019; April 16, 2019; London, United Kingdom.Passeo, Lux, Pulsar and Astron are trademarks or registered trademarks of the BIOTRONIK Group of Companies.}