Author:
Bosiers Michel J.,De Donato Gianmarco,Torsello Giovanni,Silveira Pierre Galvagni,Scheinert Dierk,Veroux Pierfrancesco,Hendriks Jeroen,Maene Lieven,Keirse Koen,Navarro Tulio,Eckstein Hans-Henning,Teβarek Jörg,Giaquinta Alessia,van den Eynde Wouter,Verbist Jürgen,Callaert Joren,Deloose Koen,Bosiers Marc
Abstract
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 ± 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.
Graphical Abstract
Publisher
Springer Science and Business Media LLC
Subject
Cardiology and Cardiovascular Medicine,Radiology, Nuclear Medicine and imaging
Cited by
1 articles.
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