Koen Deloose1, Wouter Lansink2, Marianne Brodmann3, Martin Werner4, Koen Keirse5, Yann Gouëffic6, Jürgen Verbist7, Lieven Maene8, Jeroen Hendriks9, Jerome Brunet10, Eric Ducasse11, Kara Levent12, Antoine Sauguet13, Sébastien Déglise14, Femke Vandael15. 1. AZ St. Blasius Hospital, Dendermonde, Belgium. koen.deloose@telenet.be. 2. ZOL Genk, Wouter. Sint-Jan, Genk, Belgium. 3. Medical University of Graz, Graz, Austria. 4. Hanusch Hospital, Vienna, Austria. 5. Regional Hospital Heilig Hart, Tienen, Belgium. 6. Paris Saint Joseph Hospital, Paris, France. 7. Imelda Hospital, Bonheiden, Belgium. 8. OLV Hospital, Aalst, Belgium. 9. Antwerp University Hospital, Edegem, Belgium. 10. Avignon Hospital Center, Avignon, France. 11. Bordeaux University Hospital, Bordeaux, France. 12. Triemli Hospital, Zurich, Switzerland. 13. Clinique Pasteur Hospital Toulouse, Toulouse, France. 14. Vaudois University Hospital, Lausanne, Switzerland. 15. ID3 Medical Research Center cv, Saint-Agathe Berchem, Belgium.
Abstract
PURPOSE: Although effectiveness and safety of many different paclitaxel coated balloons in the treatment of peripheral arterial disease (PAD) are extensively studied, there is a lack of direct head-to-head comparison studies. To meet this need and to avoid potential "class-effects", the BIOPACT was set up. The purpose is to demonstrate the safety and efficacy of the Passeo-18 Lux DCB (Biotronik) for treatment of patients with symptomatic PAD due to femoropopliteal lesions. METHODS: 302 patients are randomized in a 1:1 manner to treatment with either the Passeo-18 Lux DCB or the IN.PACT Admiral DCB (Medtronic) for testing of a formal non-inferiority hypothesis. The participants will be followed for 5 years. The primary efficacy endpoint is freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months, defined as any re-intervention at the target lesion due to symptoms, drop of ankle brachial index (ABI) > 20% or > 0.15 compared to post-procedural ABI. Primary safety endpoint is a composite of freedom from device/procedure-related death through 30 days post-index procedure, freedom from major target limb amputation and clinically-driven target vessel revascularization (CD-TVR) through 12 months post-index procedure. Secondary endpoints can be found at clinicaltrials.gov, ID NCT03884257. DISCUSSION: As full enrolment was reached by the beginning of September, the investigators expect complete analysis of the primary endpoints by the end of 2022; Meanwhile preliminary results will be disclosed during 2022. As in terms of randomized head-to-head efficacy and safety analysis, this study on paclitaxel coated balloons may provide additional information to clinicians and healthcare providers. Trial registration ClinicalTrials.gov ID: NCT03884257 LEVEL OF EVIDENCE: Level 2, Randomized trial.
PURPOSE: Although effectiveness and safety of many different paclitaxel coated balloons in the treatment of peripheral arterial disease (PAD) are extensively studied, there is a lack of direct head-to-head comparison studies. To meet this need and to avoid potential "class-effects", the BIOPACT was set up. The purpose is to demonstrate the safety and efficacy of the Passeo-18 Lux DCB (Biotronik) for treatment of patients with symptomatic PAD due to femoropopliteal lesions. METHODS: 302 patients are randomized in a 1:1 manner to treatment with either the Passeo-18 Lux DCB or the IN.PACT Admiral DCB (Medtronic) for testing of a formal non-inferiority hypothesis. The participants will be followed for 5 years. The primary efficacy endpoint is freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months, defined as any re-intervention at the target lesion due to symptoms, drop of ankle brachial index (ABI) > 20% or > 0.15 compared to post-procedural ABI. Primary safety endpoint is a composite of freedom from device/procedure-related death through 30 days post-index procedure, freedom from major target limb amputation and clinically-driven target vessel revascularization (CD-TVR) through 12 months post-index procedure. Secondary endpoints can be found at clinicaltrials.gov, ID NCT03884257. DISCUSSION: As full enrolment was reached by the beginning of September, the investigators expect complete analysis of the primary endpoints by the end of 2022; Meanwhile preliminary results will be disclosed during 2022. As in terms of randomized head-to-head efficacy and safety analysis, this study on paclitaxel coated balloons may provide additional information to clinicians and healthcare providers. Trial registration ClinicalTrials.gov ID: NCT03884257 LEVEL OF EVIDENCE: Level 2, Randomized trial.
Authors: Dierk Scheinert; Stephan Duda; Thomas Zeller; Hans Krankenberg; Jens Ricke; Marc Bosiers; Gunnar Tepe; Scott Naisbitt; Kenneth Rosenfield Journal: JACC Cardiovasc Interv Date: 2014-01 Impact factor: 11.195
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