ZILVERPASS Study: ZILVER PTX Stent vs Bypass Surgery in Femoropopliteal Lesions

Marc Bosiers, Carlo Setacci, Gianmarco De Donato, Giovanni Torsello, Pierre Galvagni Silveira, Koen Deloose, Dierk Scheinert, Pierfrancesco Veroux, Jeroen Hendriks, Lieven Maene, Koen Keirse, Tulio Navarro, Joren Callaert, Hans Henning Eckstein, Jörg Teβarek, Alessia Giaquinta, Jeroen Wauters

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42 Scopus citations

Abstract

Purpose: To report the 12-month results of a multicenter, prospective, randomized controlled trial to determine if the ZILVER PTX paclitaxel-eluting stent was noninferior in terms of safety and efficacy compared with surgical bypass. Materials and Methods: This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs surgical bypass surgery using a prosthetic graft (ClinicalTrials.gov identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the ZILVER PTX treatment group (113, 51.4%) or the bypass treatment group (107, 48.6%). Most of the lesions were occlusions (208, 94.5%); the mean lesion length was 247.1±69.3 mm. The primary outcome measure was primary patency at 12 months, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex-derived 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. Results: The estimated 12-month primary patency rate was 74.5% (95% CI 66.3% to 82.7%) for the ZILVER PTX group vs 72.5% (95% CI 63.7% to 81.3%) for the bypass arm (p=0.998). Freedom from TLR at 12 months was 80.9% (95% CI 73.3% to 88.5%) for the ZILVER PTX group vs 76.2% (95% CI 68.0% to 84.4%) for the bypass group (p=0.471). The 30-day complication rate was significantly lower in the ZILVER PTX group (4.4% vs 11.3%, p=0.004). Also, procedure time and hospital stay were significantly shorter in the ZILVER PTX group (p<0.001 for both). Conclusion: With noninferior patency results, a lower complication rate, and shorter procedures and hospital stays, paclitaxel-eluting stenting might become a recommended treatment for long TASC C and D femoropopliteal lesions.

Original languageEnglish
Pages (from-to)287-295
Number of pages9
JournalJournal of Endovascular Therapy
Volume27
Issue number2
DOIs
StatePublished - 1 Apr 2020
Externally publishedYes

Keywords

  • bypass surgery
  • drug-eluting stent
  • endovascular treatment
  • femoropopliteal segment
  • occlusion
  • peripheral artery disease
  • stenosis
  • superficial femoral artery

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