Gunnar Tepe1, John Wang2, Jean-Marc Corpataux3, Uei Pua4, Christoph A Binkert5, Matej Moscovic6, Reza Ghotbi7, Koen Keirse8, Donald Robertson9, Marianne Brodmann10. 1. Institut für Diagnostische und Interventionelle Radiologie, RoMed Klinikum Rosenheim, Pettenkoferstr. 10, 83022, Rosenheim, Germany. gunnar.tepe@ro-med.de. 2. Department of Vascular Surgery, Singapore General Hospital, Singapore, Singapore. 3. Department of Thoracic and Vascular Surgery, Lausanne University Hospital, Lausanne, Switzerland. 4. Department of Diagnostic Radiology, Tan Tock Seng Hospital, Singapore, Singapore. 5. Radiology Institute, Kantonsspital Winterthur, Winterthur, Switzerland. 6. Department of Angiology, Institute of Cardiovascular Diseases, Kosice, Slovakia. 7. Klinik für Gefäßchirurgie, Helios Klinikum München West, Munich, Germany. 8. Department of Vascular Surgery, Regional Hospital Heilig Hart, Tienen, Belgium. 9. Interventional Radiology, University Hospital Geelong, Geelong, Australia. 10. Division of Angiology, Department of Internal Medicine, Medical University Graz, Graz, Austria.
Abstract
PURPOSE: The BIOLUX P-III registry was initiated to further assess the safety and efficacy of the Passeo-18 Lux drug-coated balloon (DCB) in infrainguinal lesions in a real-world environment and in prespecified risk groups. MATERIALS AND METHODS: BIOLUX P-III is a prospective, global, all-comers registry with patients treated under real-world conditions. We herein report 24-month results of the prespecified subgroup of 151 patients with 185 below-the-knee (BTK) lesions. The primary safety and efficacy endpoints were freedom from major adverse events (a composite of freedom from device and procedure mortality through 30 days, major target limb amputation and clinically driven target lesion revascularization) at 6 months and freedom from clinically driven target lesion revascularization (FfTLR) at 12 months. RESULTS: At baseline, 76.0% of patients had critical limb ischemia and 48.9% of lesions were TASC C or D lesions. Technical success was achieved in 97.8%, and bailout stenting was required in 1.1%. Freedom from major adverse events was 86.2% [95% CI 79.4; 90.8] at 6 months, and FfTLR was 90.9% [95% CI 85.2; 94.4] at 12 months. At 24 months, FfTLR was 90.9% [95% CI 85.2; 94.4], freedom from major amputation was 90.1% [95% CI 83.9, 94.0], and overall survival was 79.2% [70.7, 85.5]. There was a significant clinical improvement (mean Rutherford class improvement of - 2.9 ± 1.9, p < 0.0001) and an improvement in pain (mean improvement on Wong-Baker Faces Pain Scale of - 2.7 ± 2.9, p < 0.0001). CONCLUSIONS: In this real-world DCB registry, 24-month outcomes of Passeo-18 Lux demonstrated safety and efficacy in BTK lesions with high patency rates and sustained clinical improvements at 24 months. TRIAL REGISTRATION: NCT02276313.
PURPOSE: The BIOLUX P-III registry was initiated to further assess the safety and efficacy of the Passeo-18 Lux drug-coated balloon (DCB) in infrainguinal lesions in a real-world environment and in prespecified risk groups. MATERIALS AND METHODS: BIOLUX P-III is a prospective, global, all-comers registry with patients treated under real-world conditions. We herein report 24-month results of the prespecified subgroup of 151 patients with 185 below-the-knee (BTK) lesions. The primary safety and efficacy endpoints were freedom from major adverse events (a composite of freedom from device and procedure mortality through 30 days, major target limb amputation and clinically driven target lesion revascularization) at 6 months and freedom from clinically driven target lesion revascularization (FfTLR) at 12 months. RESULTS: At baseline, 76.0% of patients had critical limb ischemia and 48.9% of lesions were TASC C or D lesions. Technical success was achieved in 97.8%, and bailout stenting was required in 1.1%. Freedom from major adverse events was 86.2% [95% CI 79.4; 90.8] at 6 months, and FfTLR was 90.9% [95% CI 85.2; 94.4] at 12 months. At 24 months, FfTLR was 90.9% [95% CI 85.2; 94.4], freedom from major amputation was 90.1% [95% CI 83.9, 94.0], and overall survival was 79.2% [70.7, 85.5]. There was a significant clinical improvement (mean Rutherford class improvement of - 2.9 ± 1.9, p < 0.0001) and an improvement in pain (mean improvement on Wong-Baker Faces Pain Scale of - 2.7 ± 2.9, p < 0.0001). CONCLUSIONS: In this real-world DCB registry, 24-month outcomes of Passeo-18 Lux demonstrated safety and efficacy in BTK lesions with high patency rates and sustained clinical improvements at 24 months. TRIAL REGISTRATION: NCT02276313.
Authors: Jihad A Mustapha; Marianne Brodmann; Patrick J Geraghty; Fadi Saab; Richard A Settlage; Michael R Jaff Journal: J Invasive Cardiol Date: 2019-08 Impact factor: 2.022
Authors: Ahmed Kayssi; Talal Al-Atassi; George Oreopoulos; Graham Roche-Nagle; Kong Teng Tan; Dheeraj K Rajan Journal: Cochrane Database Syst Rev Date: 2016-08-04