Paclitaxel-Coated Balloon Angioplasty for the Treatment of Infrainguinal Arteries: 24-Month Outcomes in the Full Cohort
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CLINICAL INVESTIGATION
ARTERIAL INTERVENTIONS
Paclitaxel-Coated Balloon Angioplasty for the Treatment of Infrainguinal Arteries: 24-Month Outcomes in the Full Cohort of BIOLUX P-III Global Registry Gunnar Tepe1,11 • Thomas Zeller2 • Matej Moscovic3 • Jean-Marc Corpataux4 • Johnny Kent Christensen5 • Koen Keirse6 • Giovanni Nano7 • Henrik Schroeder8 Christoph A. Binkert9 • Marianne Brodmann10
•
Received: 20 May 2020 / Accepted: 19 September 2020 Ó The Author(s) 2020
Abstract Purpose After promising small randomized trials, the aim of BIOLUX P-III was to further investigate the safety and performance of the Passeo-18 lx drug-coated balloon in infrainguinal arteries under real-world conditions. Methods BIOLUX P-III is a global prospective single-arm study with follow-up at 6, 12 and 24 months. The primary safety endpoint was freedom from major adverse events (MAE) within 6 months. The primary performance
Electronic supplementary material The online version of this article (https://doi.org/10.1007/s00270-020-02663-7) contains supplementary material, which is available to authorized users.
endpoint was freedom from clinically driven target lesion revascularization (TLR) within 12 months. Results 877 patients/1084 lesions were enrolled. Diabetes mellitus was present in 47.7%, and 42.1% had critical limb ischemia (CLI). The mean lesion length was 89.0 mm with 76.1% of calcified lesions, and 24.9% occluded. At 24 months, freedom from MAE was 83.1% in the full cohort; 84.9% in the femoropopliteal population (592 patients, 691 lesions); 77.7% for long lesions (187 subjects/ 192 lesions); and 72.5% in the in-stent restenosis (ISR) subgroup (103 subjects/116 lesions). Twenty-four-month freedom from clinically driven TLR was 88.1% in the full cohort; 88.9% in the femoropopliteal population; 80.3% for the long lesions; and 78.4% for ISR. Twenty-four-month 1
Department of Radiology, Klinikum Rosenheim, Rosenheim, Germany
2
Matej Moscovic [email protected]
Clinic Cardiology and Angiology II, Universita¨tsHerzzentrum Freiburg – Bad Krozingen, Bad Krozingen, Germany
3
Jean-Marc Corpataux [email protected]
Angiology Clinic, Institute of Cardiovascular Diseases, Kosice, Slovakia
4
Johnny Kent Christensen [email protected]
Department of Vascular Surgery, Lausanne University Hospital, Lausanne, Switzerland
5
Koen Keirse [email protected]
Department of Radiology, Kolding Hospital, Kolding, Denmark
6
Giovanni Nano [email protected]
Department of Vascular Surgery, Regional Hospital Heilig Hart, Tienen, Belgium
7
Henrik Schroeder [email protected]
1st Vascular Surgery Department, IRCCS Policlinico San Donato, San Donato Milanese, Italy
8
Christoph A. Binkert [email protected]
Center for Diagnostic Radiology and Minimally Invasive Therapy, Jewish Hospital, Berlin, Germany
9
Radiology Institute, Kantonsspital Winterthur, Winterthur, Switzerland
& Gunnar Tepe [email protected] Thomas Zeller [email protected]
Marianne Br
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