Evidence map›Paper›PMID 38228879›Full record

ArticleCardiovascular and interventional radiology2024

Treatment of Femoropopliteal Artery Disease with Polymer-Coated Drug-Eluting Stent: 5-Year Results of a Prospective, Non-Randomized Study Including the Halo Phenomenon.

Giovanni Federico Torsello, Konstantinos Stavroulakis, Theodosios Bisdas, Yamel Cardona, Katrin Wichmann, Giovanni Battista Torsello

Open access · hybridAbstract read
In one paragraph

Article in Cardiovascular and interventional radiology, 2024. 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
4.0field-weighted citation impact, top 7% 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, 7 citations in OpenAlex.

  1. Pooled it
  2. Trial
  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

6 authors at 4 institutions in 2 countries.

Giovanni Federico TorselloDepartment of Diagnostic and Interventional Radiology, Institute of Diagnostic and Interventional Radiology, Göttingen Medical Center, University Medical Center Göttingen, Robert-Koch-Strasse 40, 37075, Göttingen, Germany. giovanni.torsello@med.uni-goettingen.de.ORCID http://orcid.org/0000-0002-9938-2947
Konstantinos StavroulakisDepartment of Vascular Surgery, Ludwigs-Maximilians-University, Munich, Germany.
Theodosios BisdasDepartment of Vascular Surgery, Athens Medical Center, Athens, Greece.
Yamel CardonaInstitute for Vascular Research, St. Franziskus Hospital, Münster, Germany.
Katrin WichmannInstitute for Vascular Research, St. Franziskus Hospital, Münster, Germany.
Giovanni Battista TorselloInstitute for Vascular Research, St. Franziskus Hospital, Münster, Germany.
St. Franziskus Hospital · DEUniversitätsmedizin Göttingen · DEAthens Medical Center · GRLudwig-Maximilians-Universität München · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo investigate the long-term results of the Eluvia drug-eluting stent (DES) implantation for femoropopliteal arterial disease, including the 'halo' phenomenon. Long-term data of DES is scarce. A focal reaction ('halo') following Eluvia DES deployment has been described. However, the long-term clinical impact of this phenomenon remains unclear.

methodsThis prospective, non-randomized, single-arm study included 130 consecutive patients treated with an Eluvia DES for symptomatic femoropopliteal disease between March 2016 and December 2018. Clinical outcomes and imaging were assessed after 6 months and annually thereafter for up to 5 years. The primary outcome measure was primary patency. Secondary outcomes were freedom from clinically driven target lesion revascularization (CD-TLR), freedom from major amputation, overall survival and amputation-free survival rates.

resultsThe primary patency was 65% at 5 years. The freedom from CD-TLR and from major amputation at 5 years was 79 and 96%, respectively. The overall survival and amputation-free survival rates were 88 and 83% at 60 months, respectively. Out of the 27 patients with a halo sign, two showed an increased (7.4%) and 6 (22.2%) a decreased diameter. In 19 cases (70.4%), the diameter remained unchanged at the latest follow-up. The presence of the 'halo' sign was associated with increased primary patency (87% versus 59%, HR: 2.48, 95%CI 1.19-5.16, P = .015).

conclusionsThe presented patient cohort treated with the Eluvia DES for femoropopliteal artery lesions indicates durable efficacy and a good safety profile regardless of the halo phenomenon. The results need to be confirmed in a larger patient cohort. LEVEL OF EVIDENCE III: Non-randomized controlled cohort/follow-up study.

Indexed as

Drug-Eluting StentsPeripheral Arterial DiseaseFemoral ArteryFollow-Up StudiesHumansPaclitaxelPolymersPopliteal ArteryProspective StudiesTreatment OutcomeVascular PatencyPaclitaxelPolymersDrug-eluting stentFemoropopliteal arteryHalo signPaclitaxelPeripheral arterial disease

Identifiers

PMID38228879
PMCPMC10844144
OpenAlexW4390906265

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.