Medizinische Universität Graz - Research portal
Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
Gregorio, MA; Brodmann, M; Martinez, Ruiz, E; Manteca, JC; Ruiz, Salmeron, R; Munoz, Ruiz-Canela, JJ; Trujillo, IG; Tepe, G.
Drug Coated Balloon for the Treatment of Long Segment Femoropopliteal Artery Disease: Pooled Analysis from BIOLUX P-III SPAIN and BIOLUX P-III All-Comers Registry Long Lesion Subgroup.
J Vasc Interv Radiol. 2023;
Doi: 10.1016/j.jvir.2023.06.041
Web of Science
PubMed
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- Co-authors Med Uni Graz
- Brodmann Marianne
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- Abstract:
- PURPOSE: The Passeo-18 Lux DCB long lesion cohort analysis was designed to further investigate the clinical performance and safety of Passeo-18 Lux DCB in complex femoropopliteal TASC C and D lesions in an all-comers patient population. MATERIAL AND METHODS: Data from the BIOLUX P-III SPAIN, a prospective, national, multi-center, post-market all-comers registry conducted from 2017 to 2019, and a matching long lesion subgroup from the BIOLUX P-III global all-comers registry conducted from 2014 to 2018, were pooled for analysis. The primary safety endpoint is freedom from major adverse events (MAE) at 6 months and the primary performance endpoint is fCD-TLR at 12 months both adjudicated by an independent Clinical Events Committee. RESULTS: A total of 159 patients of which 32.7% had critical limb ischemia were included in the Passeo-18 Lux long lesion cohort. Mean lesion length was 248.5 mm ± 71.6 mm and the majority were occluded (54.1%), calcified (87.4%) and were of type TASC C (49.1%) and type TASC D (50.9%). Freedom from MAEs was 90.6% [95% CI 84.6, 94.3] at 6 months and 83.9% [95% CI 76.7, 89.0] at 12 months. fCD-TLR was 84.4% [95% CI 77.3, 89.5] at 12 months. Freedom from target limb major amputation was 98.6% [95% CI 94.6, 99.7] and all-cause mortality was 5.3% [95% CI 2.7, 10.4] at 12 months. There were no device- or procedure-related death or amputation up to 12-month follow-up. CONCLUSION: Passeo-18 Lux DCB is safe and effective for the treatment of long femoropopliteal lesions in a real-word setting.