Medizinische Universität Graz - Research portal
Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
Deloose, KR; Lansink, W; Brodmann, M; Werner, M; Keirse, K; Gouëffic, Y; Verbist, J; Maene, L; Hendriks, JMH; Brunet, J; Ducasse, E; Levent, K; Sauguet, A; Vandael, F; Vercauteren, S; Callaert, J.
Head-to-Head Comparison of 2 Paclitaxel-Coated Balloons for Femoropopliteal Lesions.
JACC Cardiovasc Interv. 2023; 16(23):2900-2914
Doi: 10.1016/j.jcin.2023.10.055
Web of Science
PubMed
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- Co-authors Med Uni Graz
- Brodmann Marianne
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- Abstract:
- BACKGROUND: There is a scarcity of published head-to-head comparisons between different paclitaxel-coated angioplasty balloons. More prospective safety data to support the health care economic reimbursement processes are needed. OBJECTIVES: The aim of this study was to report the safety and efficacy of the Passeo-18 Lux drug-coated balloon (DCB) (Biotronik AG) for the treatment of symptomatic peripheral artery disease caused by stenosis, restenosis, or occlusion of the femoral and/or popliteal arteries. METHODS: A total of 302 patients were randomized 1:1 and assigned to the Passeo-18 Lux DCB (study device) group or the IN.PACT Admiral DCB (control device, Medtronic Vascular) group for testing of noninferiority. The primary efficacy endpoint was freedom from clinically driven target lesion revascularization at 12 months. The primary safety endpoint was a composite of freedom from device-/procedure-related death through 30 days postindex procedure, major target limb amputation, and clinically driven target vessel revascularization at 12 months. RESULTS: At 12 months, 130 of 134 patients in the IN.PACT Admiral group had freedom from clinically driven target lesion revascularization (97.0%) compared with 137 of 141 patients in the Passeo-18 Lux group (97.2%). The primary safety endpoint showed 96.3% in the control group vs 95.7% in the study device group. The null hypothesis of inferiority on both efficacy and safety was rejected. The Kaplan-Meier estimate of primary patency at 1 year was 88.7% in the control arm vs 91.5% in the study device arm. CONCLUSIONS: The Passeo-18 Lux and the IN.PACT Admiral DCBs demonstrate comparable results with excellent effectiveness and safety through 12 months for femoropopliteal interventions.
- Find related publications in this database (using NLM MeSH Indexing)
- Humans - administration & dosage
- Femoral Artery - diagnostic imaging
- Treatment Outcome - administration & dosage
- Paclitaxel - adverse effects
- Prospective Studies - administration & dosage
- Coated Materials, Biocompatible - administration & dosage
- Time Factors - administration & dosage
- Popliteal Artery - diagnostic imaging
- Angioplasty, Balloon - adverse effects
- Peripheral Arterial Disease - diagnostic imaging, therapy
- Vascular Patency - administration & dosage
- Find related publications in this database (Keywords)
- drug-coated balloon
- IN.PACT Admiral
- Passeo-1 8 Lux
- randomized controlled trial