Evidence map›Paper›PMID 40745698›Full record

Observational studyClinical cardiology2025

Long-Term Effectiveness of a Stent-Less Strategy With Drug Coated Balloon in Coronary Artery Disease: 3-Year Follow-Up of a Prospective All-Comers Observational Study.

Ludovic Meunier, Simon Eccleshall, Ronan Bakdi, Matthieu Godin, Géraud Souteyrand, Benoît Mottin, Yann Valy, Christian Benoit, Vincent Lordet, Virginie Laurençon and 3 more

Registry-linked trialAbstract readObservational Study
In one paragraph

Observational study in Clinical cardiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03893396 (Safety Assessment of Angioplasty Procedures), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT03893396 completednot on this map

Safety Assessment of Angioplasty Procedures

Typeobservational_patient_registrySponsorGroupe Hospitalier de la Rochelle Ré AunisRan2019 to 2023Enrolled983ConditionsAngiospastic, DisorderArmsCoronary angioplasty
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

13 authors.

Ludovic MeunierCardiology Department, Centre Hospitalier la Rochelle, la Rochelle, France.
Simon EccleshallNorfolk and Norwich University Hospital, Norwich, UK.
Ronan BakdiCardiology Department, Centre Hospitalier la Rochelle, la Rochelle, France.
Matthieu GodinCardiology Department, Clinique St-Hilaire, Rouen, France.
Géraud SouteyrandDépartement de Cardiologie, CHU Clermont-Ferrand, ISIT, CaVITI, CNRS (UMR-6284), Université d'Auvergne, Clermont-Ferrand, France.
Benoît MottinCardiology Department, Centre Hospitalier la Rochelle, la Rochelle, France.
Yann ValyCardiology Department, Centre Hospitalier la Rochelle, la Rochelle, France.
Christian BenoitCardiology Department, Centre Hospitalier la Rochelle, la Rochelle, France.
Vincent LordetCardiology Department, Centre Hospitalier la Rochelle, la Rochelle, France.
Virginie LaurençonClinical Trials Unit, Centre Hospitalier la Rochelle, la Rochelle, France.
Antoine MilhemCardiology Department, Centre Hospitalier la Rochelle, la Rochelle, France.ORCID https://orcid.org/0000-0002-1292-824X
Matthias WaliszewskiMedical Scientific Affairs, B. Braun Melsungen AG, Berlin, Germany.
Caroline Allix-BéguecClinical Trials Unit, Centre Hospitalier la Rochelle, la Rochelle, France.ORCID https://orcid.org/0000-0001-7642-4844

Funding

This study was supported by the Groupe Hospitalier de la Rochelle Ré Aunis [2018P02283] and B. Braun [l-FR-2019-0184/MEDAG-19-00166].
6 · The paper itself

Abstract

introductionDrug-eluting stent (DES) angioplasty is the gold standard treatment for coronary lesions. Drug-coated balloon (DCB) is an option for in-stent restenosis, and has also shown promise for small-calibre coronary artery disease. We evaluated the 3-year effectiveness of a decision algorithm for percutaneous coronary intervention (PCI) that favoured a stent-less strategy (SLS) in primary angioplasty.

methodsAll patients who underwent angioplasty during 1 year were included in a prospective observational study. Patients eligible for SLS first underwent scoring balloon followed by DCB angioplasty or DES in case of mandatory bailout. Patients not eligible for SLS were unstable patients who underwent conventional drug-eluting stenting. The metal index, stent burden, was calculated by stent length divided by the total lesion length. A 36-month follow-up recorded target lesion revascularization (TLR).

resultsPatients eligible for SLS represented 85% (n = 840) of patients who underwent PCI. TLR was required in 2.6% and 6% of patients in the DCB-only and bailout-DES groups, respectively. Median metal index was 0.25 (IQR: 0.5) in patients with TLR. There was a difference between TLR-free survival distributions in the DCB-only and bailout-DES groups (p = 0.016).

conclusionsThe SLS based on a combination of scoring balloon and DCB was effective at 3 years with a low rate of TLR. This rate was higher in patients with stent burden.

trial registrationThis study was registered with clinicaltrials. gov (NCT03893396, first posted on March 28, 2019).

Indexed as

Angioplasty, Balloon, CoronaryCardiac CathetersCoated Materials, BiocompatibleCoronary Artery DiseaseCoronary RestenosisDrug-Eluting StentsPercutaneous Coronary InterventionAgedCoronary AngiographyFemaleFollow-Up StudiesHumansMaleMiddle AgedProspective StudiesProsthesis DesignCoated Materials, Biocompatibleangioplastycoronary artery diseaseDCB‐based strategydrug‐coated balloondrug‐eluting stentpatient outcome assessmentpercutaneous coronary intervention

Identifiers

PMID40745698
PMCPMC12313834

What OpenQuestion holds

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Registered trials

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.