Evidence map›Paper›PMID 32881396›Full record

ArticleCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions2021

BIOSOLVE-IV-registry: Safety and performance of the Magmaris scaffold: 12-month outcomes of the first cohort of 1,075 patients.

Stefan Verheye, Adrian Wlodarczak, Piero Montorsi, Jan Torzewski, Johan Bennett, Michael Haude, Gregory Starmer, Thomas Buck, Marcus Wiemer, Amin A B Nuruddin and 2 more

Registry-linked trialOpen access · hybridAbstract readMulticenter Study
In one paragraph

Article in Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06409117 (3rd Generation Resorbable Magnesium Scaffolds vs Biodegradable Polymer Drug Eluting Stents in Patients With Non ST-segment Elevation Acute Coronary Syndromes), which is not on this map. Cited by 49 papers.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed
10.4field-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.

NCT06409117 phase4not yet recruitingnot on this mapstarted 2024, after this paper: background citation

3rd Generation Resorbable Magnesium Scaffolds vs Biodegradable Polymer Drug Eluting Stents in Patients With Non ST-segment Elevation Acute Coronary Syndromes: the RESORB-ACS Randomized Clinical Trial

TypeinterventionalSponsorKonstantinos ToutouzasRan2024 to 2027Enrolled220ConditionsAcute Coronary Syndrome, Coronary Artery DiseaseArmsPercutaneous coronary intervention
3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 72 citations in OpenAlex.

  1. Trial
  2. 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
  3. First-in-human evaluation of a novel ultrathin sirolimus-eluting iron bioresorbable scaffold: 3-year outcomes of the IBS-FIM trial.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2023
    Trial
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  17. 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
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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

12 authors at 12 institutions in 8 countries.

Stefan VerheyeInterventional Cardiology, ZNA Cardiovascular Center Middelheim, Antwerp, Belgium.ORCID 0000-0002-2182-1065
Adrian WlodarczakMiedziowe Centrum Zdrowia S.A., Lubin, Poland.
Piero MontorsiDepartment of Clinical Sciences and Community Health, University of Milan and Centro Cardiologico Monzino, IRCCS, Milan, Italy.
Jan TorzewskiCardiovascular Center Oberallgäu-Kempten, Kempten, Germany.
Johan BennettDepartment of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium.ORCID 0000-0002-8301-4517
Michael HaudeMedical Clinic I Städtische Kliniken Neuss Lukaskrankenhaus GmbH, Neuss, Germany.ORCID 0000-0002-1364-840X
Gregory StarmerDepartment of Cardiology, Cairns Hospital, Cairns, Australia.
Thomas BuckDepartment of Cardiology, Herz Zentrum Westfalen, Klinikum Westfalen, Dortmund, Germany.
Marcus WiemerDepartment of Cardiology and Intensive Care, Johannes Wesling University Hospital Ruhr University Bochum, Minden, Germany.
Amin A B NuruddinDepartment of Cardiology Institute Jantung Negara, Kuala Lumpur, Malaysia.
Bryan P-Y YanDivision of Cardiology, Department of Medicine and Therapeutics, Prince of Wales Hospital, Hong Kong, Hong Kong.ORCID 0000-0003-0430-5752
Michael K-Y LeeDivision of Cardiology, Queen Elizabeth Hospital, Kowloon, Hong Kong.
Cairns Hospital · AUCentrum Badań Jakości · PLJohannes Wesling Klinikum Minden · DEKempten University of Applied Sciences · DEKlinikum Westfalen (Germany) · DEKU Leuven · BELukaskrankenhaus · DENational Heart Institute · MYPrince of Wales Hospital · CNQueen Elizabeth Hospital · GBUniversity of Milan · ITZNA Middelheim Hospital · BE

Funding

Biotronik
6 · The paper itself

Abstract

objectivesWe aimed to assess the safety and performance of the Magmaris sirolimus-eluting bioresorbable magnesium scaffold in a large patient population.

backgroundMagmaris has shown good outcomes in small-sized controlled trials, but further data are needed to confirm its usability, safety, and performance.

methodsBIOSOLVE-IV is an international, single arm, multicenter registry including patients with a maximum of two single de novo lesions. Follow-up is scheduled up to 5 years; the primary outcome is target lesion failure (TLF) at 12 months.

resultsA total of 1,075 patients with 1,121 lesions were enrolled. Mean patient age was 61.3 ± 10.5 years and 19.2% (n = 206) presented with non-ST-elevation myocardial infarction (NSTEMI). Lesions were 3.2 ± 0.3 mm in diameter and 14.9 ± 4.2 mm long; 5.1% (n = 57) were bifurcation lesions. Device success was 97.3% (n = 1,129) and procedure success 98.9% (n = 1,063). The Kaplan-Meier estimate of TLF at 12 months was 4.3% [95% confidence interval, CI: 3.2, 5.7] consisting of 3.9% target lesion revascularizations, 0.2% cardiac death, and 1.1% target-vessel myocardial infarction. Definite/probable scaffold thrombosis occurred in five patients (0.5% [95% CI: 0.2, 1.1]), thereof four after early discontinuation of antiplatelet/anticoagulation therapy.

conclusionBIOSOLVE-IV confirms the safety and performance of the Magmaris scaffold in a large population with excellent device and procedure success and a very good safety profile up to 12 months in a low-risk population.

Indexed as

Coronary Artery DiseaseDrug-Eluting StentsAgedHumansMiddle AgedProspective StudiesRegistriesTreatment Outcomebioresorbable scaffoldscoronary artery diseasemagnesiumNSTEMIsirolimus

Identifiers

PMID32881396
PMCPMC8359313
OpenAlexW3083419860

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.