Evidence map›Paper›PMID 37670198›Full record

Trial reportCardiovascular and interventional radiology2023

ZILVERPASS Study: ZILVER PTX Stent versus Prosthetic Above-the-Knee Bypass Surgery in Femoropopliteal Lesions, 5-year Results.

Michel J Bosiers, Gianmarco De Donato, Giovanni Torsello, Pierre Galvagni Silveira, Dierk Scheinert, Pierfrancesco Veroux, Jeroen Hendriks, Lieven Maene, Koen Keirse, Tulio Navarro and 8 more

Open access · hybridAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Cardiovascular and interventional radiology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 12 institutions in 4 countries.

Michel J BosiersDepartment of Vascular Surgery, St. Franziskus-Hospital, Münster, Germany. michel.bosiers@hotmail.com.
Gianmarco De DonatoDepartment of Vascular Surgery, University of Siena, Siena, Italy.
Giovanni TorselloDepartment of Vascular Surgery, St. Franziskus-Hospital, Münster, Germany.
Pierre Galvagni SilveiraDepartment of Vascular Surgery, UFSC University Hospital Santa Catarina, Florianópolis, Brazil.
Dierk ScheinertDepartment of Angiology, University Hospital of Leipzig, Leipzig, Germany.
Pierfrancesco VerouxDepartment of Vascular Surgery, University Hospital of Catania, Catania, Italy.
Jeroen HendriksDepartment of Vascular Surgery, University Hospital of Antwerp, Edegem, Belgium.
Lieven MaeneDepartment of Vascular Surgery, OLV Hospital Aalst, Aalst, Belgium.
Koen KeirseDepartment of Vascular Surgery, RZ Heilig Hart Tienen, Tienen, Belgium.
Tulio NavarroDepartment of Vascular Surgery, Federal University of Minas Gerais, Belo Horizonte, Brazil.
Hans-Henning EcksteinDepartment of Vascular Surgery, Klinikum Rechts Der Isar, Munich, Germany.
Jörg TeβarekDepartment of Vascular Surgery, St. Bonifatius Hospital Lingen, Lingen, Germany.
Alessia GiaquintaDepartment of Vascular Surgery, University Hospital of Catania, Catania, Italy.
Wouter van den EyndeDepartment of Vascular Surgery, Imelda Hospital, Bonheiden, Belgium.
Jürgen VerbistDepartment of Vascular Surgery, Imelda Hospital, Bonheiden, Belgium.
Joren CallaertDepartment of Vascular Surgery, AZ St. Blasius, Dendermonde, Belgium.
Koen DelooseDepartment of Vascular Surgery, AZ St. Blasius, Dendermonde, Belgium.
Marc BosiersDepartment of Vascular Surgery, AZ St. Blasius, Dendermonde, Belgium.
AZ Sint-Blasius · BEImelda Hospital · BEUniversity of Catania · ITAntwerp University Hospital · BEKlinikum rechts der Isar · DEOnze Lieve Vrouwziekenhuis Hospital · BEPolydoro Ernani de São Thiago University Hospital · BRSt. Bonifatius Hospital · DESt. Franziskus Hospital · DEUniversidade Federal de Minas Gerais · BRUniversity Hospital Leipzig · DEUniversity of Siena · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo 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

methodsPatients 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.

results220 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).

conclusionEven 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.

Indexed as

Drug-Eluting StentsPeripheral Arterial DiseaseAgedFemoral ArteryHumansMaleMiddle AgedNeoplasm Recurrence, LocalPaclitaxelPopliteal ArteryProspective StudiesProsthesis DesignStentsTreatment OutcomeVascular PatencyPaclitaxelDrug-eluting-stentFemoropoplitealPADProsthetic bypass

Identifiers

PMID37670198
PMCPMC10547807
OpenAlexW4386456436

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.