Publication
Title
ZILVERPASS study : ZILVER PTX stent versus prosthetic above-the-knee bypass surgery in femoropopliteal lesions, 5-year results
Author
Abstract
Purpose To report the 60-month safety and effectiveness results of a multicenter, prospective, randomized controlled trial comparing the ZILVER PTX paclitaxel-eluting stent to prosthetic above-the-knee bypass for the treatment of symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions.Materials and methods Patients were enrolled between October 2013 and July 2017. One of the secondary outcomes was primary patency at 60 months, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex ultrasound peak systolic velocity ratio < 2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass at 60 months. Survival rates after 5 years were also analyzed.Results 220 patients (mean age 68.6 & PLUSMN; 10.5 years; 159 men) were included and randomized to ZILVER PTX (n = 113, 51.40%) or BYPASS group (n = 107, 48.60%). The 60-month primary patency rate was 49.3% for the ZILVER PTX group versus 40.7% for the bypass group (p = 0.6915). Freedom from TLR was 63.8% for the ZILVER PTX group versus 52.8% for the bypass group (p = 0.2637). At 5 years, no significant difference in survival rate could be seen between the ZILVER PTX and the bypass group (69.1% vs. 71% respectively, p = 0.5503).Conclusion Even at 5 years, non-inferior safety and effectiveness results of the ZILVER PTX could be seen. These findings confirmed that the use of ZILVER PTX stents can be considered as a valid alternative for bypass surgery when treating long and complex femoropopliteal lesions. [GRAPHICS]
Language
English
Source (journal)
Cardiovascular and interventional radiology. - Berlin, 1980, currens
Publication
New york : Springer , 2023
ISSN
0174-1551 [print]
1432-086X [online]
DOI
10.1007/S00270-023-03549-0
Volume/pages
46 (2023) , p. 1348-1358
ISI
001062722600001
Pubmed ID
37670198
Full text (Publisher's DOI)
Full text (open access)
UAntwerpen
Faculty/Department
Research group
Publication type
Subject
Affiliation
Publications with a UAntwerp address
External links
Web of Science
Record
Identifier
Creation 02.10.2023
Last edited 28.12.2023
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