Evidence map›Paper›PMID 25349065›Full record

ArticleClinical research in cardiology : official journal of the German Cardiac Society2015

Local paclitaxel induces late lumen enlargement in coronary arteries after balloon angioplasty.

Franz X Kleber, Antonia Schulz, Matthias Waliszewski, Telse Hauschild, Michael Böhm, Ulrich Dietz, Bodo Cremers, Bruno Scheller, Yvonne P Clever

4 registry-linked trialsAbstract read
PubMed Publisher
In one paragraph

Article in Clinical research in cardiology : official journal of the German Cardiac Society, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 90 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
90citing papers in PubMed, 7 pooled it
9.7field-weighted citation impact, top 1% 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.

NCT04893291 naactive not recruitingnot on this mapstarted 2021, after this paper: background citation

Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels - TRANSFORM II

TypeinterventionalSponsorFondazione Ricerca e Innovazione Cardiovascolare ETSRan2021 to 2030Enrolled1,820ConditionsCoronary Artery Disease, Coronary Artery StenosisArmsEverolimus Eluting Stent, Sirolimus Coated Balloon
NCT06321757 active not recruitingnot on this mapstarted 2024, after this paper: background citation

PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients

Typeobservational_patient_registrySponsorFundación EPICRan2024 to 2026Enrolled501ConditionsCoronary Artery DiseaseArmsPercutaneous Coronary Intervention with DCB and DAPT
NCT06746233 narecruitingnot on this mapstarted 2024, after this paper: background citation

A Prospective, Randomized, Multicenter, International, Open-Label Clinical Trial Comparing Drug-Coated Balloon and Drug-Eluting Stent for the Treatment of Acute ST-Elevation Myocardial Infarction.

TypeinterventionalSponsorInstitute of Cardiovascular Diseases, VojvodinaRan2024 to 2028Enrolled598ConditionsST Elevation Myocardial Infarction (STEMI)ArmsDrug (paclitaxel) coated balloon (DCB), Second-generation Drug Eluting Stent (DES)
NCT06822322 nanot yet recruitingnot on this mapstarted 2025, after this paper: background citation

The European Bifurcation Club Randomized Trial of Stepwise Provisional Stenting Versus Drug Coated Balloon Therapy for Non-left Main True Coronary Bifurcations - EBC DCB Study

TypeinterventionalSponsorCeric SàrlRan2025 to 2035Enrolled750ConditionsCoronary Artery Disease (non-left Main), Coronary Bifurcation LesionArmsPercutaneous Coronary Angioplasty, Stepwise Provisional Stent Strategy, Drug Coated Balloon Strategy, Cross-Over Stepwise Provisional Stent Strategy
3 · Its place in the literature

Who cites it

90 citing papers in PubMed, 7 syntheses or guidelines pooled it, 206 citations in OpenAlex.

  1. Pooled it
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  10. A randomised trial of sirolimus- versus paclitaxel-coated balloons for de novo coronary lesions.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024
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  11. The "Journal of interventional cardiology · 2023
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  20. Drug-Coated Balloons Beyond In-Stent Restenosis.Reviews in cardiovascular medicine · 2026
    Review

30 more citing papers are in PubMed but not listed here.

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

9 authors at 4 institutions in 1 country.

Franz X KleberCardio Centrum Berlin, Academic Teaching Institution, Charité Universitätsmedizin, Unter den Linden 21, 10117, Berlin, Germany, fxkleber@gmx.eu.
Antonia Schulz
Matthias Waliszewski
Telse Hauschild
Michael Böhm
Ulrich Dietz
Bodo Cremers
Bruno Scheller
Yvonne P Clever
Universitätsklinikum des Saarlandes · DECharité - Universitätsmedizin Berlin · DEB. Braun (Germany) · DEDeutsche Klinik für Diagnostik · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study investigated p aclitaxel-induced luminal changes following drug-coated balloon (DCB) angioplasty to treat coronary de novo lesions without additional stenting. DCB-mediated local drug delivery reduces late lumen loss in de novo coronary artery lesions. We performed a retrospective clinical assessment based on a pre-specified quantitative coronary angiography (QCA) protocol.

methodsQCA was performed for each centre to assess the primary endpoint late lumen changes, i.e. the difference between in-lesion minimal lumen diameter (MLD) at the routine angiographic follow-up as compared to post-procedural in-lesion MLDs. These MLD changes were compared to corresponding reference vessel diameter changes as an intra-patient control.

resultsWe evaluated 58 consecutive native coronary artery lesions directly after DCB angioplasty and at a routine target follow-up angiography of 4 months by QCA. Target lesion MLD increased significantly within the 4.1 ± 2.1 month observation period (1.75 ± 0.55 vs. 1.91 ± 0.55 mm, p < 0.001, diameter stenosis 33.8 ± 12.3 vs. 26.9 ± 13.8 %, p < 0.001), while there were no changes in non-target reference vessel diameters (2.33 ± 0.60 vs. 2.34 ± 0.61 mm, p = ns). A total of 69 % of patients showed luminal enlargement whereas 29 % had minor luminal loss.

conclusionLocal application of paclitaxel by DCB angioplasty to native coronary arteries after pre-dilatation without major dissection and recoil leads to late lumen increase.

Indexed as

Cardiac CathetersCoated Materials, BiocompatibleAgedAngioplasty, Balloon, CoronaryCardiovascular AgentsCoronary AngiographyCoronary Artery DiseaseCoronary RestenosisCoronary VesselsFemaleHumansHyperplasiaMaleMiddle AgedNeointimaPaclitaxelCardiovascular AgentsCoated Materials, BiocompatiblePaclitaxel

Identifiers

PMID25349065
OpenAlexW1988800629

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.