Evidence map›Paper›PMID 37113674›Full record

ArticleEClinicalMedicine2023

Safety and performance of the third-generation drug-eluting resorbable coronary magnesium scaffold system in the treatment of subjects with de novo coronary artery lesions: 6-month results of the prospective, multicenter BIOMAG-I first-in-human study.

Michael Haude, Adrian Wlodarczak, René J van der Schaaf, Jan Torzewski, Bert Ferdinande, Javier Escaned, Juan F Iglesias, Johan Bennett, Gabor Toth, Michael Joner and 6 more

Registry-linked trialAbstract read
In one paragraph

Article in EClinicalMedicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04157153 (BIOTRONIK - Safety and Clinical Performance of the - Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System), which is not on this map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing 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.

NCT04157153 naactive not recruitingnot on this map

BIOTRONIK - Safety and Clinical Performance of the - Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System (DREAMS 3G) in the Treatment of Subjects With de Novo Lesions in Native Coronary Arteries

TypeinterventionalSponsorBiotronik AGRan2020 to 2027Enrolled116ConditionsCoronary Artery DiseaseArmsImplantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold
3 · Its place in the literature

Who cites it

20 citing papers in PubMed.

  1. Trial
  2. Trial
  3. A new resorbable magnesium scaffold for de novo coronary lesions (DREAMS 3): one-year results of the BIOMAG-I first-in-human study.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2023
    Trial
  4. Article
  5. Review
  6. Review
  7. The Impact of Underlying Plaque Characteristics Following the Third-Generation Resorbable Magnesium Scaffold Implantation: An Intravascular OCT Assessment up to 12-Months.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2025
    Article
  8. Review
  9. Article
  10. Progress in research and development of biodegradable metallic vascular stents.Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2024
    Review
  11. Article
  12. Article
  13. 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.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024
    Article
  14. Review
  15. Review
  16. Review
  17. Article
  18. Review
  19. Review
  20. Review
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

16 authors.

Michael HaudeMedical Clinic I, Rheinland Klinikum Neuss GmbH, Lukaskrankenhaus, Neuss, Germany.
Adrian WlodarczakDepartment of Cardiology, Miedziowe Centrum Zdrowia SA, Lubin, Poland.
René J van der SchaafDepartment of Interventional Cardiology, OLVG, Amsterdam, the Netherlands.
Jan TorzewskiCardiovascular Center Oberallgäu-Kempten, Germany.
Bert FerdinandeDepartment of Cardiology, Ziekenhuis Oost Limburg (ZOL), Genk, Belgium.
Javier EscanedDivision of Cardiology, Hospital Clinico San Carlos IDISSC, Complutense University of Madrid, Madrid, Spain.
Juan F IglesiasCardiology Division, University Hospital of Geneva, Geneva, Switzerland.
Johan BennettDepartment of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium.
Gabor TothDivision Cardiology, Medical University Graz, Graz, Austria.
Michael JonerKlinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, München, Germany.
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, Skane University Hospital, Lund, Sweden.
Paul VermeerschInterventional Cardiology ZNA Middelheim, Antwerpen, Belgium.
Hector M Garcia-GarciaInterventional Cardiology, MedStar Washington Hospital Center, Washington DC, USA.
Ron WaksmanInterventional Cardiology, MedStar Washington Hospital Center, Washington DC, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: A third-generation coronary drug-eluting resorbable magnesium scaffold (DREAMS 3G) was developed to enhance the performance of previous scaffold generations and achieve angiographic outcomes comparable to those of contemporary drug-eluting stents. Methods: This prospective, multicenter, non-randomized, first-in-human study was conducted at 14 centers in Europe. Eligible patients had stable or unstable angina, documented silent ischemia, or non-ST-elevation myocardial infarction, and a maximum of two single de novo lesions in two separate coronary arteries with a reference vessel diameter between 2.5 mm and 4.2 mm. Clinical follow-up was scheduled at one, six and 12 months and annually thereafter until five years. Invasive imaging assessments were scheduled six and 12 months postoperatively. The primary endpoint was angiographic in-scaffold late lumen loss at six months. This trial was registered at ClinicalTrials.gov (NCT04157153). Findings: Between April 2020 and February 2022, 116 patients with 117 coronary artery lesions were enrolled. At six months, in-scaffold late lumen loss was 0.21 mm (SD 0.31). Intravascular ultrasound assessment showed preservation of the scaffold area (mean 7.59 mm Interpretation: These findings show that the implantation of DREAMS 3G in de novo coronary lesions is associated with favorable safety and performance outcomes, comparable to contemporary drug-eluting stents. Funding: This study was funded by BIOTRONIK AG.

Indexed as

Bioresobabe scaffoldsCoronary artery diseaseDrug-eluting stents

Identifiers

PMID37113674
PMCPMC10126775

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.