Author + information
- Received May 18, 2020
- Revision received June 25, 2020
- Accepted June 30, 2020
- Published online October 5, 2020.
- Marianne Brodmann, MDa,∗ (, )
- Matej Moscovic, MDb,
- John Chaw Chian Wang, MDc,
- Giovanni Nano, MDd,
- Johannes Dahm, MDe,
- Thomas Zeller, MDf,
- Johnny Kent Christensen, MDg,
- Koen Keirse, MDh,
- Reza Ghotbi, MDi,
- Jean-Marc Corpataux, MDj and
- Gunnar Tepe, MDk
- aDivision of Angiology, Medical University Graz, Graz, Austria
- bAngiology Clinic, Institute of Cardiovascular Diseases, Kosice, Slovakia
- cDepartment of Vascular Surgery, Singapore General Hospital, Singapore
- d1st Vascular Surgery Department, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy
- eDepartment of Angiology and Cardiology, Herz- und Gefäßzentrum Neu-Bethlehem, Göttingen, Germany
- fClinic Cardiology and Angiology II, Universitäts-Herzzentrum Freiburg – Bad Krozingen, Bad Krozingen, Germany
- gDepartment of Radiology, Kolding Hospital, Kolding, Denmark
- hDepartment of Vascular Surgery, Regional Hospital Heilig Hart, Tienen, Belgium
- iKlinik für Gefäßchirurgie, Helios Klinikum München West, Munich, Germany
- jDepartment of Thoracic and Vascular Surgery, Lausanne University Hospital, Lausanne, Switzerland
- kDepartment of Interventional Radiology, Klinikum Rosenheim, Rosenheim, Germany
- ↵∗Address for correspondence:
Prof. Dr. Marianne Brodmann, Department of Angiology, Medical University Graz, Auenbruggerplatz 15, 8036 Graz, Austria.
Objectives The aim of the BIOLUX P-III (A Prospective, International, Multi-Centre, Post-Market All-Comers Registry to Assess the Clinical Performance of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Infrainguinal Arteries – III) registry was to collect real-world data on the Passeo-18 Lux paclitaxel-coated balloon.
Background Critical limb ischemia (CLI) is a severe condition associated with high morbidity and mortality. Prospective data are needed to provide further insights on drug-eluting devices.
Methods BIOLUX P-III is a prospective, post-market, all-comers registry assessing the safety and performance of the Passeo-18 Lux. Clinical information was collected at 6, 12, and 24 months. The authors report 24-month outcomes of the CLI subgroup with patients in Rutherford classes 4 to 6.
Results The CLI subgroup included 328 patients with 422 lesions. Patients were 71.1 ± 10.5 years of age, and 61.0% had diabetes. Femoropopliteal lesions were present in 53.8% (n = 227), below-the-knee lesions were present in 27.0% (n = 114), and lesions were moderate or heavily calcified in 45.0% (n = 190). Major adverse events, defined as 30-day device- or procedure-related mortality, major target limb amputation, and clinically driven target lesion revascularization, occurred in 9.8% of patients through 6 months, in 14.9% through 12 months, and in 19.4% through 24 months. Clinically driven target lesion revascularization occurred in 4.4%, 8.5%, and 12.1%, major amputation in 4.9%, 5.2%, and 6.1%, and mortality in 8.1%, 11.1%, and 20.1%, respectively. Predictors of mortality were age ≥75 years and higher Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease class, and higher Rutherford class was associated with increased mortality and amputation rates.
Conclusions 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.
- chronic limb-threatening ischemia
- critical limb ischemia
- drug-coated balloon
- drug-eluting balloon
- peripheral artery disease
This study was sponsored by Biotronik. The sponsor was involved in the study design, conduct of the study, and statistical analysis. Furthermore, the sponsor reimbursed the medical writer who worked under the guidance of the coordinating author. The sponsor was not involved in the decision to submit the manuscript. Dr. Brodmann has received honoraria from Abbott Vascular, Biotronik, Philips-Spectranetics, Medtronic, Daiichi Sankyo, Bayer Healthcare, and BD Bard; is a consultant for Boston Scientific, Medtronic, Spectranetics, Intact Vascular, Shockwave, Bayer, Vesper Medical, and BD Bard; and has received study support from 480 Biomedical, BD Bard, Biotronik, Medtronic, Philips, Shockwave, Med Alliance, Intact Vascular, and B. Braun. Dr. Dahm has received honoraria from AstraZeneca and Pfizer. Dr. Zeller has received honoraria from Abbott Vascular, Veryan, Biotronik, Boston Scientific, Cook Medical, Gore & Associates, Medtronic, Philips-Spectranetics, TriReme, Veryan, Shockwave, Biotronik, and B. Braun; is a consultant for Boston Scientific, Cook Medical, Gore & Associates, Medtronic, Spectranetics, Veryan, Intact Vascular, and Veryan; and holds common stock in QT Medical. Dr. Ghotbi has cooperative research agreements with and performs consulting for Philips-Spectranetics, BD Bard, and Gore. Dr. Tepe has received study support from B. Braun, Bard, Bayer, Biotronik, Boston Scientific, Gore, Medtronic, Philips, and Veryan. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Cardiovascular Interventions author instructions page.
- Received May 18, 2020.
- Revision received June 25, 2020.
- Accepted June 30, 2020.
- 2020 The Authors