Biotronik has announced the two-year results from the BIOLUX P-III BENELUX all-comers registry, presented by principal investigator Frank Vermassen (Ghent University, Gent, Belgium) at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023 annual meeting (9–13 September, Copenhagen, Denmark).
The prospective, international, multicentre post-market registry evaluated the safety and efficacy of the Passeo-18 Lux drug-coated balloon (DCB) catheter in isolated popliteal artery lesions. This indication is considered a difficult vessel bed to treat due to its biomechanical constraints that usually preclude the placement of stents.
BIOLUX P-III BENELUX registry enrolled 99 patients in Belgium, The Netherlands, and Luxembourg with Rutherford 2–5 disease and at least two centimetres of healthy vessel segment between lesions in the popliteal artery and lesions in the distal superficial femoral artery. All patients were treated with the Passeo-18 Lux DCB. The bail-out stenting rate was 14%.
At 24 months:
- Freedom from clinically driven target lesion revascularisation (CD-TLR)2 was 81.6%
- Freedom from major target limb amputation was 98.0%
- Freedom from all-cause of death was 89.4%
- Significant improvement of Rutherford classification was observed for 88.1% of the patients.
“We face a scarcity of data evaluating endovascular therapy for isolated popliteal artery lesions, known as a difficult vessel bed to treat as we don’t want to leave anything behind,” said Vermassen. “It is encouraging to see that we can safely and effectively treat these lesions with a DCB-only approach.”
“Biotronik is proud to be a leader in research of paclitaxel-coated balloons, striving to study device performance in the most challenging anatomy and patient characteristics,” said Stuart Perks, vice president of marketing, vascular intervention at Biotronik. “We repeatedly see the safety and effectiveness of Passeo-18 Lux DCB demonstrated in a diverse range of clinical presentations.”