Real-world experience with a Paclitaxel-Coated Balloon for the treatment of atherosclerotic infrainguinal arteries: 12-month interim results of the BIOLUX P-III registry first year of enrolment.
Marianne Brodmann,Thomas Zeller,Johnny Kent Christensen,Christoph A. Binkert,Lubomir,Henrik Schröder,Paolo Righini,Giovanni Nano,Gunnar Tepe +8 more
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In a real-world environment, the BIOLUX P-III registry preliminary results confirm the safety and efficacy of the Paclitaxel-Coated Passeo-18 Lux balloon as a stand-alone treatment option for atherosclerotic infrainguinal arteries.Abstract:
Background Endovascular management of atherosclerotic infrainguinal arteries recently shifted towards drug eluting devices, designed to locally prevent the restenosis process. Numerous clinical studies report an advantage of drug coated balloons over uncoated balloon angioplasty in treating lower extremity peripheral artery disease. However, as coating and balloon platforms are different, each device requires dedicated clinical evaluations. Objective The aim of the study is to further investigate the safety and effectiveness of a Paclitaxel-Coated Balloon for the treatment of atherosclerotic infrainguinal arteries in a real-world setting. Methods 203 patients out of a final sample of 882 were enrolled in this prospective multicenter, observational, all-comers registry during the first 12 months. The primary endpoints were major adverse events (defined as procedure or device related death within 30 days post index procedure, clinically-driven target lesion revascularization or major target limb amputation) at 6 months and freedom from clinically-driven target lesion revascularization at 12 months. Both endpoints were adjudicated by a Clinical Events Committee. Results Mean patient age was 70.2±10.4 years (60.1% male). 47.3% of the patients were diabetic and 67.5% had a history of smoking. Severe claudication was reported in 37.4% and 40% had critical limb ischemia. 257 lesions, including 13.2% in the infrapopliteal territory, were treated with Passeo-18 Lux (mean lesion length 75.1 mm±69.4, 20% occlusions, 76.3% calcified). At 6 months, the rate of major adverse events was 5.5% (95%CI 3.1-9.7). Freedom from clinically-driven target lesion revascularization at 12 months was 93.2% (95%CI 89.1-95.8). All causes mortality was 6.5% (95%CI 3.8-11.0) and overall amputation rate was 4.2% (95%CI 2.1-8.3) at 12 months. Conclusion In a real-world environment, the BIOLUX P-III registry preliminary results confirm the safety and efficacy of the Paclitaxel-Coated Passeo-18 Lux balloon as a stand-alone treatment option for atherosclerotic infrainguinal arteries.read more
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Drug Coated Balloon Angioplasty vs. Standard Percutaneous Transluminal Angioplasty in Below the Knee Peripheral Arterial Disease: A Systematic Review and Meta-Analysis
TL;DR: No significant differences in limb salvage, survival, restenosis, TLR, and AFS rates were found when DCB angioplasty was compared with standard PTA, according to this systematic review and meta-analysis.
Journal ArticleDOI
Paclitaxel-Coated Balloon for the Treatment of Infrainguinal Disease: 12-Month Outcomes in the All-Comers Cohort of BIOLUX P-III Global Registry.
Gunnar Tepe,Thomas Zeller,Matej Moscovic,Jean-Marc Corpataux,Johnny Kent Christensen,Koen Keirse,Giovanni Nano,Henrik Schroeder,Christoph A. Binkert,Marianne Brodmann +9 more
TL;DR: In a real-world patient population, the safety and performance of the Passeo-18 Lux DCB for the treatment of atherosclerotic infrainguinal lesions are maintained, with good performance outcomes and low complication rates at 12 months.
Journal ArticleDOI
Real-World Experience With a Paclitaxel-Coated Balloon in Critical Limb Ischemia: 24-Month Subgroup Outcomes of BIOLUX P-III
Marianne Brodmann,Matej Moscovic,John C. Wang,Giovanni Nano,Johannes B. Dahm,Thomas Zeller,Johnny Kent Christensen,Koen Keirse,Reza Ghotbi,Jean-Marc Corpataux,Gunnar Tepe +10 more
TL;DR: In a large, multimorbid patient population with complex lesions and CLI, the safety and performance of the Passeo-18 Lux paclitaxel-coated balloon has been confirmed, with low rates of major amputation and target lesion revascularization.
Journal ArticleDOI
Paclitaxel-Coated Balloon Angioplasty for the Treatment of Infrainguinal Arteries: 24-Month Outcomes in the Full Cohort of BIOLUX P-III Global Registry
Gunnar Tepe,Thomas Zeller,Matej Moscovic,Jean-Marc Corpataux,Johnny Kent Christensen,Koen Keirse,Giovanni Nano,Henrik Schroeder,Christoph A. Binkert,Marianne Brodmann +9 more
TL;DR: The BIOLUX P-III 24-month outcomes confirm the safety and performance of Passeo-18 lx in infrainguinal arteries in a large population treated under real-world conditions with low complication rates and good clinical outcomes.
Journal ArticleDOI
Helical stent (SUPERA™) and drug-coated balloon (Passeo-18 Lux™) for recurrent cephalic arch stenosis: Rationale and design of arch V SUPERA-LUX Study.
TL;DR: The Arch V SUPERA-LUX study is the first trial to evaluate whether SUPERA stent implantation and drug-coated balloon use can provide superior protection against restenosis compared to traditional angioplasty, bare metal stents and stent grafts in recurrent cephalic arch stenosis.
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Journal ArticleDOI
Drug-Coated Balloon Versus Standard Percutaneous Transluminal Angioplasty for the Treatment of Superficial Femoral and Popliteal Peripheral Artery Disease 12-Month Results From the IN.PACT SFA Randomized Trial
Gunnar Tepe,John R. Laird,Peter Schneider,Marianne Brodmann,Prakash Krishnan,Antonio Micari,Christopher Metzger,Dierk Scheinert,Thomas Zeller,David J. Cohen,David Snead,Beaux Alexander,Mario Landini,Michael R. Jaff +13 more
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