Real-World Experience With a Paclitaxel-Coated Balloon in Critical Limb Ischemia: 24-Month Subgroup Outcomes of BIOLUX P-III |
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Institution: | 1. Division of Angiology, Medical University Graz, Graz, Austria;2. Angiology Clinic, Institute of Cardiovascular Diseases, Kosice, Slovakia;3. Department of Vascular Surgery, Singapore General Hospital, Singapore;4. 1st Vascular Surgery Department, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy;5. Department of Angiology and Cardiology, Herz- und Gefäßzentrum Neu-Bethlehem, Göttingen, Germany;6. Clinic Cardiology and Angiology II, Universitäts-Herzzentrum Freiburg – Bad Krozingen, Bad Krozingen, Germany;7. Department of Radiology, Kolding Hospital, Kolding, Denmark;8. Department of Vascular Surgery, Regional Hospital Heilig Hart, Tienen, Belgium;9. Klinik für Gefäßchirurgie, Helios Klinikum München West, Munich, Germany;10. Department of Thoracic and Vascular Surgery, Lausanne University Hospital, Lausanne, Switzerland;11. Department of Interventional Radiology, Klinikum Rosenheim, Rosenheim, Germany |
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Abstract: | ObjectivesThe 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.BackgroundCritical 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.MethodsBIOLUX 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.ResultsThe 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.ConclusionsIn 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. |
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Keywords: | chronic limb-threatening ischemia critical limb ischemia drug-coated balloon drug-eluting balloon peripheral artery disease BTK"} {"#name":"keyword" "$":{"id":"kwrd0040"} "$$":[{"#name":"text" "_":"below-the-knee CI"} {"#name":"keyword" "$":{"id":"kwrd0050"} "$$":[{"#name":"text" "_":"confidence interval CLI"} {"#name":"keyword" "$":{"id":"kwrd0060"} "$$":[{"#name":"text" "_":"critical limb ischemia CLTI"} {"#name":"keyword" "$":{"id":"kwrd0070"} "$$":[{"#name":"text" "_":"chronic limb-threatening ischemia DCB"} {"#name":"keyword" "$":{"id":"kwrd0080"} "$$":[{"#name":"text" "_":"drug-coated balloon MAE"} {"#name":"keyword" "$":{"id":"kwrd0090"} "$$":[{"#name":"text" "_":"major adverse event(s) TASC"} {"#name":"keyword" "$":{"id":"kwrd0100"} "$$":[{"#name":"text" "_":"Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease TLR"} {"#name":"keyword" "$":{"id":"kwrd0110"} "$$":[{"#name":"text" "_":"target lesion revascularization WIfI"} {"#name":"keyword" "$":{"id":"kwrd0120"} "$$":[{"#name":"text" "_":"wound ischemia and foot infection |
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