Evidence map›Paper›PMID 39279514›Full record

ArticleEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology2024

Vascular response following implantation of the third-generation drug-eluting resorbable coronary magnesium scaffold: an intravascular imaging analysis of the BIOMAG-I first-in-human study.

Masaru Seguchi, Alp Aytekin, Erion Xhepa, Michael Haude, Adrian Wlodarczak, René J van der Schaaf, Jan Torzewski, Bert Ferdinande, Javier Escaned, Juan F Iglesias and 9 more

Abstract read
In one paragraph

Article in EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

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

2 citing papers in PubMed.

  1. Review
  2. Serial intracoronary imaging to predict efficacy and safety of magnesium-based resorbable scaffolds.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024
    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

19 authors.

Masaru SeguchiKlinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany.
Alp AytekinKlinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany.
Erion XhepaKlinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany.
Michael HaudeDepartment of Cardiology, Rheinland Klinikum Neuss, Neuss, Germany.
Adrian WlodarczakDepartment of Cardiology, Miedziowe Centrum Zdrowia S.A., Lubin, Poland.
René J van der SchaafDepartment of Interventional Cardiology, OLVG, Amsterdam, the Netherlands.
Jan TorzewskiCardiovascular Center Oberallgäu-Kempten, Kempten, Germany.
Bert FerdinandeDepartment of Cardiology, Ziekenhuis Oost Limburg (ZOL), Genk, Belgium.
Javier EscanedDivision of Cardiology, Hospital Clínico San Carlos (IdISSC), Complutense University of Madrid, CIBERCV, Madrid, Spain.
Juan F IglesiasDepartment of Cardiology, Geneva University Hospitals, Geneva, Switzerland.
Johan BennettDepartment of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium.
Gabor G TothDivision of Cardiology, Medical University Graz, Graz, Austria.
Ralph ToelgCardiology Department, Heart Center Segeberger Kliniken, Bad Segeberg, Germany.
Marcus WiemerDepartment of Cardiology and Intensive Care, Johannes Wesling University Hospital, Ruhr University Bochum, Minden, Germany.
Göran OlivecronaDepartment of Cardiology, Skåne University Hospital, Lund, Sweden.
Paul VermeerschInterventional Cardiology, ZNA Middelheim, Antwerp, Belgium.
Ron WaksmanInterventional Cardiology, MedStar Washington Hospital Center, Washington, D.C., USA.
Hector M Garcia-GarciaInterventional Cardiology, MedStar Washington Hospital Center, Washington, D.C., USA.
Michael JonerKlinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 12-month outcomes of BIOMAG-I - the first-in-human study investigating the third-generation drug-eluting resorbable magnesium scaffold (DREAMS 3G) - showed promising results regarding clinical outcomes and late lumen loss.

aimsThe current study aimed to investigate vascular healing parameters assessed by optical coherence tomography (OCT) and intravascular ultrasound (IVUS), focusing on strut visibility, vessel and scaffold areas, and neointimal growth patterns.

methodsThis is a BIOMAG-I substudy including patients with available serial OCT and IVUS data. We conducted a frame-based analysis of OCT findings in conjunction with IVUS-derived vessel and scaffold areas, evaluating the qualitative and quantitative aspects of vascular healing.

resultsAmong the 116 patients enrolled in this trial, 56 patients treated with DREAMS 3G were included in the analysis. At 12 months, OCT imaging revealed that 99.0% of the struts were invisible, and no malapposed struts were depicted. While the vessel area showed no significant difference between the timepoints, the minimum lumen area significantly decreased from post-percutaneous coronary intervention to 6 months (6.88 mm

conclusionsThis imaging substudy revealed that, at 12-month follow-up, virtually all struts of the DREAMS 3G scaffold became invisible, without evident malapposition. The vascular healing response to DREAMS 3G implantation also appeared favourable up to 12 months, which is indicated by advanced strut degradation and spontaneous regressing PNT between 6 and 12 months.

Indexed as

Absorbable ImplantsCoronary Artery DiseaseCoronary VesselsDrug-Eluting StentsMagnesiumPercutaneous Coronary InterventionTomography, Optical CoherenceUltrasonography, InterventionalAgedFemaleHumansMaleMiddle AgedNeointimaTissue ScaffoldsTreatment OutcomeMagnesium

Identifiers

PMID39279514
PMCPMC11384225

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.