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Wittig, T. ; Schmidt, A.* ; Kabelitz, M.* ; Hukauf, M.* ; Pflug, T.* ; Scheinert, D.* ; Steiner, S.

Safety and efficacy of all-comers treated with paclitaxel-coated balloon for below the knee intervention.

Eur. J. Vasc. Endovasc. Surg. 64, 516-525 (2022)
Postprint DOI PMC
Open Access Green
OBJECTIVES: Data on PCB for below the knee (BTK) angioplasty exhibited conflicting efficacy results and previous meta-analyses suggested an increased mortality and amputation risk highlighting the need for further research. The aim of this study was to investigate safety and efficacy of Paclitaxel coated balloons (PCB) for BTK interventions in a real-world cohort. METHODS: Within a single-center cohort study 552 consecutive patients were included undergoing BTK interventions with and without PCB use. Two-year safety and efficacy results were compared in unadjusted and propensity score matched (PSM) analysis. RESULTS: BTK interventions were performed in 157 patients with PCB angioplasty (100% Lutonix 0.014" drug coated balloon; Bard Lutonix, New Hope, Minnesota, USA) and 395 patients with plain old balloon angioplasty (POBA). The majority of interventions (>70%) were performed for chronic limb threatening ischemia (CLTI). Mean lesion length was 20.8±12.6cm. 61.2% in the PCB and 66.7% in the POBA group were occlusions. In the PCB group, more procedures were performed for restenotic lesions compared to POBA (28.5 vs. 17.2%). In PSM analysis (128 matched pairs), the primary efficacy endpoint was freedom from clinically-driven target lesion revascularization (CD TLR), which occurred in 70.1% in the PCB and 73.1% in the POBA group at 1 year (p=.85; McNemar Test). Survival analysis suggested lower rates of major amputations in the PCB group in unadjusted (94.4%±2.1 vs. 89.2%±1.9 in the POBA group) and PSM analyses (97.2%±1.6 vs. 89.3%±3.5) through 2 years, while no differences were seen for CD TRL and all-cause mortality between the groups. CONCLUSION: In this all-comer analysis, PCB was found to be safe for BTK interventions with a signal towards lower amputation rates but no benefit was seen for repeat revascularization.
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Publikationstyp Artikel: Journalartikel
Dokumenttyp Wissenschaftlicher Artikel
Korrespondenzautor
Schlagwörter Paclitaxel Coated Balloon ; Angioplasty ; Below The Knee ; Mortality; Drug-eluting Balloon; Long-term Outcomes; Infrapopliteal Arteries; The-knee; Angioplasty; Metaanalysis; Risk; Revascularization; Mortality; Disease
ISSN (print) / ISBN 1078-5884
e-ISSN 1078-5884
Zeitschrift European Journal of Vascular and Endovascular Surgery
Quellenangaben Band: 64, Heft: 5, Seiten: 516-525 Artikelnummer: , Supplement: ,
Verlag Elsevier
Verlagsort 32 Jamestown Rd, London Nw1 7by, England
Nichtpatentliteratur Publikationen
Begutachtungsstatus Peer reviewed
Institut(e) Helmholtz Institute for Metabolism, Obesity and Vascular Research (HI-MAG)
Förderungen C.R. Bard