Paclitaxel-Coated Balloon for the Treatment of Infrainguinal Disease: 12-Month Outcomes in the All-Comers Cohort of BIOLUX P-III Global Registry: 12-Month Outcomes in the All-Comers Cohort of BIOLUX P-III Global Registry
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| Titel: | Paclitaxel-Coated Balloon for the Treatment of Infrainguinal Disease: 12-Month Outcomes in the All-Comers Cohort of BIOLUX P-III Global Registry: 12-Month Outcomes in the All-Comers Cohort of BIOLUX P-III Global Registry |
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| Autoren: | Tepe G., Zeller T., Moscovic M., Corpataux J. -M., Christensen J. K., Keirse K., Nano G., Schroeder H., Binkert C. A., Brodmann M. |
| Quelle: | J Endovasc Ther Journal of endovascular therapy, vol. 27, no. 2, pp. 304-315 Tepe, G, Zeller, T, Moscovic, M, Corpataux, J M, Christensen, J K, Keirse, K, Nano, G, Schroeder, H, Binkert, C A & Brodmann, M 2020, ' Paclitaxel-Coated Balloon for the Treatment of Infrainguinal Disease : 12-Month Outcomes in the All-Comers Cohort of BIOLUX P-III Global Registry ', Journal of Endovascular Therapy, vol. 27, no. 2, pp. 304-315 . https://doi.org/10.1177/1526602819898804 |
| Verlagsinformationen: | SAGE Publications, 2020. |
| Publikationsjahr: | 2020 |
| Schlagwörter: | critical limb ischemia, Male, chronic limb-threatening ischemia, drug-coated balloon, drug-eluting balloon, femoropopliteal segment, paclitaxel, peripheral artery disease, superficial femoral artery, Asia, Paclitaxel, Taxol, Lower and Upper Limb Interventions, Aged, Amputation, Surgical, Angioplasty, Balloon/adverse effects, Angioplasty, Balloon/instrumentation, Australia, Cardiovascular Agents/administration & dosage, Cardiovascular Agents/adverse effects, Coated Materials, Biocompatible, Equipment Design, Europe, Female, Femoral Artery/diagnostic imaging, Femoral Artery/physiopathology, Humans, Limb Salvage, Paclitaxel/administration & dosage, Paclitaxel/adverse effects, Peripheral Arterial Disease/diagnostic imaging, Peripheral Arterial Disease/physiopathology, Peripheral Arterial Disease/therapy, Popliteal Artery/diagnostic imaging, Popliteal Artery/physiopathology, Progression-Free Survival, Prospective Studies, Registries, Time Factors, Vascular Access Devices, Vascular Patency, Periphere arterielle Verschlusskrankheit, Peripheral Arterial Disease, 03 medical and health sciences, 0302 clinical medicine, Drug-eluting Stent, Femoropoplitealer Bypass, Ischämiesyndrom, Popliteal Artery, 2. Zero hunger, Cardiovascular Agents, Oberschenkelarterie, 3. Good health, Femoral Artery, Ischämie, Angioplasty, Balloon |
| Beschreibung: | Purpose: To further investigate the safety and performance of the Passeo-18 Lux drug-coated balloon (DCB) for the treatment of atherosclerotic infrainguinal disease under real-world conditions. Materials and Methods: BIOLUX P-III is an international, prospective, observational registry ( ClinicalTrials.gov identifier NCT02276313) conducted at 41 centers in Europe, Asia, and Australia with follow-up visits at 6, 12, and 24 months. Of 700 patients (mean age 70.0±10.2 years; 439 men) with 863 lesions in the all-comers cohort, 330 (47.1%) patients had diabetes and 234 (37.7%) had chronic limb-threatening ischemia. The majority (79.3%) of lesions were in the femoropopliteal segment; of all lesions, 645 (74.9%) were calcified and 99 (11.5%) had in-stent restenosis (ISR). The mean lesion length was 84.7±73.3 mm. The primary clinical endpoint was major adverse events (MAEs) within 6 months, a composite of device- and procedure-related mortality through 30 days, major target limb amputation, and clinically-driven target lesion revascularization (TLR). The primary performance endpoint was clinically-driven TLR within 12 months. Results: At 6 and 12 months, freedom from MAEs was 94.0% and 89.5% in the all-comers cohort: 95.0% and 91.2% in the femoropopliteal group and 95.3% and 88.0% in the ISR subgroup, respectively. Freedom from clinically-driven TLR at 12 months was 93.1% in the all-comers cohort, 93.9% in the femoropopliteal lesions, and 89.4% for ISR lesions. All-cause mortality was 6.1% in the all-comers cohort: 5.9% in both the femoropopliteal and ISR subgroups. There were no device- or procedure-related deaths at up to 12 months. The Rutherford category improved in >80% of all subgroups at 12 months. Conclusion: 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. |
| Publikationsart: | Article Other literature type |
| Dateibeschreibung: | application/pdf; pdf |
| Sprache: | English |
| ISSN: | 1545-1550 1526-6028 |
| DOI: | 10.1177/1526602819898804 |
| Zugangs-URL: | https://journals.sagepub.com/doi/pdf/10.1177/1526602819898804 https://pubmed.ncbi.nlm.nih.gov/31989855 https://journals.sagepub.com/doi/pdf/10.1177/15266028211014307 https://pubmed.ncbi.nlm.nih.gov/31989855/ https://journals.sagepub.com/doi/pdf/10.1177/1526602819898804 https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/31989855/ https://findresearcher.sdu.dk:8443/ws/files/169699384/1526602819898804.pdf https://moh-it.pure.elsevier.com/en/publications/paclitaxel-coated-balloon-for-the-treatment-of-infrainguinal-dise https://hdl.handle.net/2434/736149 https://doi.org/10.1177/1526602819898804 http://nbn-resolving.org/urn/resolver.pl?urn=urn:nbn:ch:serval-BIB_24BE92B4DA110 https://serval.unil.ch/notice/serval:BIB_24BE92B4DA11 https://serval.unil.ch/resource/serval:BIB_24BE92B4DA11.P001/REF.pdf https://findresearcher.sdu.dk:8443/ws/files/169699384/1526602819898804.pdf |
| Rights: | CC BY NC |
| Dokumentencode: | edsair.doi.dedup.....0dcbe88819c4f9e72bd0ef5e8ac2e86b |
| Datenbank: | OpenAIRE |
Nájsť tento článok vo Web of Science | Abstract: | Purpose: To further investigate the safety and performance of the Passeo-18 Lux drug-coated balloon (DCB) for the treatment of atherosclerotic infrainguinal disease under real-world conditions. Materials and Methods: BIOLUX P-III is an international, prospective, observational registry ( ClinicalTrials.gov identifier NCT02276313) conducted at 41 centers in Europe, Asia, and Australia with follow-up visits at 6, 12, and 24 months. Of 700 patients (mean age 70.0±10.2 years; 439 men) with 863 lesions in the all-comers cohort, 330 (47.1%) patients had diabetes and 234 (37.7%) had chronic limb-threatening ischemia. The majority (79.3%) of lesions were in the femoropopliteal segment; of all lesions, 645 (74.9%) were calcified and 99 (11.5%) had in-stent restenosis (ISR). The mean lesion length was 84.7±73.3 mm. The primary clinical endpoint was major adverse events (MAEs) within 6 months, a composite of device- and procedure-related mortality through 30 days, major target limb amputation, and clinically-driven target lesion revascularization (TLR). The primary performance endpoint was clinically-driven TLR within 12 months. Results: At 6 and 12 months, freedom from MAEs was 94.0% and 89.5% in the all-comers cohort: 95.0% and 91.2% in the femoropopliteal group and 95.3% and 88.0% in the ISR subgroup, respectively. Freedom from clinically-driven TLR at 12 months was 93.1% in the all-comers cohort, 93.9% in the femoropopliteal lesions, and 89.4% for ISR lesions. All-cause mortality was 6.1% in the all-comers cohort: 5.9% in both the femoropopliteal and ISR subgroups. There were no device- or procedure-related deaths at up to 12 months. The Rutherford category improved in >80% of all subgroups at 12 months. Conclusion: 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. |
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| ISSN: | 15451550 15266028 |
| DOI: | 10.1177/1526602819898804 |