Evidence map›Paper›PMID 37226676›Full record

ArticleEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology2023

One- and two-year clinical outcomes of treatment with resorbable magnesium scaffolds for coronary artery disease: the prospective, international, multicentre BIOSOLVE-IV registry.

Adrian Wlodarczak, Piero Montorsi, Jan Torzewski, Johan Bennett, Gregory Starmer, Thomas Buck, Michael Haude, Marco Moccetti, Marcus Wiemer, Michael-Kang-Yin Lee and 1 more

Open access · greenAbstract readMulticenter Study
In one paragraph

Article in EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
4.1field-weighted citation impact, top 6% 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.

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

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

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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

11 authors at 6 institutions in 3 countries.

Adrian WlodarczakCopper Health Center, Lubin, Poland.
Piero MontorsiDepartment of Clinical Sciences and Community Health, University of Milan, Milan, Italy and Centro Cardiologico Monzino, IRCCS, Milan, Italy.
Jan TorzewskiCardiovascular Center Oberallgäu-Kempten, Kempten, Germany.
Johan BennettDepartment of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium.
Gregory StarmerDepartment of Cardiology, Cairns Hospital, Cairns, QLD, Australia.
Thomas BuckDepartment of Cardiology, HerzZentrum Westfalen, Klinikum Westfalen, Dortmund, Germany.
Michael HaudeMedical Clinic I, Rheinland Klinikum Neuss GmbH, Lukaskrankenhaus, Neuss, Germany.
Marco MoccettiIstituto Cardiocentro Ticino, Lugano, Switzerland.
Marcus WiemerDepartment of Cardiology and Intensive Care, Johannes Wesling University Hospital, Ruhr University Bochum, Minden, Germany.
Michael-Kang-Yin LeeDivision of Cardiology, Queen Elizabeth Hospital, Kowloon, Hong Kong SAR, China.
Stefan VerheyeInterventional Cardiology, ZNA Cardiovascular Center Middelheim, Antwerp, Belgium.
Epatocentro Ticino · CHJohannes Wesling Klinikum Minden · DEKempten University of Applied Sciences · DEKU Leuven · BELukaskrankenhaus · DEZNA Middelheim Hospital · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBioresorbable scaffolds have been developed to overcome the limitations of drug-eluting stents and to reduce long-term adverse events.

aimsWe aimed to assess the long-term safety and efficacy of a sirolimus-eluting resorbable magnesium scaffold to ensure its safe rollout into clinical routine.

methodsBIOSOLVE-IV is a prospective, international, multicentre registry including more than 100 centres in Europe, Asia, and Asia-Pacific. Enrolment started directly after the commercialisation of the device. Follow-up assessments are scheduled at 6 and 12 months, and annually for up to 5 years; we herein report the 24-month outcomes.

resultsOverall, 2,066 patients with 2,154 lesions were enrolled. Patients were 61.9±10.5 years old, 21.6% had diabetes, and 18.5% had non-ST-elevation myocardial infarction (NSTEMI). Lesions were 14.8±4.0 mm long with a reference vessel diameter of 3.2±0.3 mm. Device and procedure success were 97.5%, and 99.1%, respectively. The 24-month target lesion failure (TLF) rate was 6.8%, mainly consisting of clinically driven target lesion revascularisations (6.0%). Patients with NSTEMI had significantly higher TLF rates than those without (9.3% vs 6.2%; p=0.025), whereas there were no significant differences observed for patients with diabetes or with type B2/C lesions (a 24-month TLF rate of 7.0% and 7.9%, respectively). The 24-month rate of definite or probable scaffold thrombosis was 0.8%. Half of the scaffold thromboses occurred after premature discontinuation of antiplatelet/anticoagulation therapy, and only one scaffold thrombosis occurred beyond the 6-month follow-up, on day 391.

conclusionsThe BIOSOLVE-IV registry showed good safety and efficacy outcomes, confirming a safe rollout of the Magmaris into clinical practice.

Indexed as

Coronary Artery DiseaseDiabetes MellitusNon-ST Elevated Myocardial InfarctionPercutaneous Coronary InterventionThrombosisAbsorbable ImplantsAgedHumansMagnesiumMiddle AgedProspective StudiesRegistriesTreatment OutcomeMagnesium

Identifiers

PMID37226676
PMCPMC10266381
OpenAlexW4378173566

What Socratic 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 Socratic graph.