Evidence map›Paper›PMID 26768146›Full record

Trial reportClinical research in cardiology : official journal of the German Cardiac Society2016

Drug eluting balloons as stand alone procedure for coronary bifurcational lesions: results of the randomized multicenter PEPCAD-BIF trial.

Franz X Kleber, Harald Rittger, Josef Ludwig, Antonia Schulz, Detlef G Mathey, Michael Boxberger, Ralf Degenhardt, Bruno Scheller, Ruth H Strasser

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical research in cardiology : official journal of the German Cardiac Society, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06822322 (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), which is not on this map. Cited by 85 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
85citing papers in PubMed, 11 pooled it
–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.

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

85 citing papers in PubMed, 11 syntheses or guidelines pooled it.

  1. Pooled it
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  7. Effect of Drug-Coated Balloon in Side Branch Protection forFrontiers in cardiovascular medicine · 2021
    Pooled it
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  12. Trial
  13. Sirolimus-coated versus paclitaxel-coated balloons for bifurcated coronary lesions in the side branch: the SPACIOUS trial.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2025
    Trial
  14. 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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  16. Review
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  19. Revascularization with drug-coated balloons alone in complex coronary artery disease: a systematic review.Clinical research in cardiology : official journal of the German Cardiac Society · 2026
    Article
  20. Article

25 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.

Franz X KleberCardio Centrum Berlin, Academic Teaching Institution, Charité University Medicine Berlin, Unter den Linden 21, 10117, Berlin, Germany. fxk@gmx.eu.
Harald RittgerUniversitätsklinikum Erlangen, Erlangen, Germany.
Josef LudwigUniversitätsklinikum Erlangen, Erlangen, Germany.
Antonia SchulzCardio Centrum Berlin, Academic Teaching Institution, Charité University Medicine Berlin, Unter den Linden 21, 10117, Berlin, Germany.
Detlef G MatheyUniversitäres Herz- und Gefäßzentrum Hamburg, Hamburg, Germany.
Michael BoxbergerMedical Scientific Affairs, B. Braun Melsungen AG, Melsungen, Germany.
Ralf DegenhardtCenter for Cardiovascular Diseases, Rotenburg a.d. Fulda, Germany.
Bruno SchellerUniversitätsklinikum des Saarlandes, Homburg, Saar, Germany.
Ruth H StrasserTechnische Universität Dresden, Herzzentrum Dresden, Universitätsklinik Dresden, Dresden, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesWe set out to investigate the benefit of distal main or side branch treatment with a DCB compared to POBA in coronary bifurcation lesions.

backgroundThe standard treatment of bifurcation lesions is application of a DES to the main branch with provisional side branch stenting. While this resulted in considerable improvement in overall MACE rate suboptimal side branch results remained a problem.

methodsThe study was performed from 2011 to 2013 in six German centers. Native bifurcation lesions were included if side branch vessel diameter was ≥2 and ≤3.5 mm and no proximal main branch lesions was found. After successful predilatation randomization was performed to either DCB application or no further treatment. Follow-up angiograms for QCA analysis were done after 9 months. Primary endpoint was late lumen loss (LLL).

results64 patients were successfully randomized. Minimal lumen diameter and grade of stenosis were equal in both groups. Only five stents were used as bail out. Angiographic follow-up was achieved in 75 % of patients. No patient died. There was one NSTEMI in the POBA group. Restenosis rate was 6 % in the DCB group vs 26 % in the POBA group (p = 0.045). TLR was necessary in one patient of the DCB group vs three patients of the POBA. The primary endpoint LLL was 0.13 mm in the DCB vs 0.51 mm in the POBA group (p = 0.013).

conclusionIn bifurcation lesions that show only class A or B dissection and recoil not beyond 30 % the use of DCBs is a sound strategy.

Indexed as

Cardiac CathetersCoated Materials, BiocompatibleAgedAngioplasty, Balloon, CoronaryCardiovascular AgentsCoronary AngiographyCoronary StenosisEquipment DesignFemaleGermanyHumansMaleMiddle AgedPaclitaxelSeverity of Illness IndexStentsCardiovascular AgentsCoated Materials, BiocompatiblePaclitaxelCoronary bifurcation lesionsDrug-coated balloon (DCB)PCI

Identifiers

PMID26768146

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.