Evidence map›Paper›PMID 28183306›Full record

ArticleCardiovascular diabetology2017

Third generation drug eluting stent (DES) with biodegradable polymer in diabetic patients: 5 years follow-up.

Marcus Wiemer, Sinisa Stoikovic, Alexander Samol, Zisis Dimitriadis, Juan M Ruiz-Nodar, Ralf Birkemeyer, Jacques Monsegu, Gérard Finet, David Hildick-Smith, Damras Tresukosol and 5 more

Erratum issuedAbstract readMulticenter Study
In one paragraph

Article in Cardiovascular diabetology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 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.

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

16 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Review
  6. Article
  7. Applying Principles of Regenerative Medicine to Vascular Stent Development.Frontiers in bioengineering and biotechnology · 2022
    Review
  8. CABG versus PCI in the Treatment of Unprotected Left Main Disease in Diabetics: A Literature Review.The International journal of angiology : official publication of the International College of Angiology, Inc · 2021
    Review
  9. Article
  10. Drug-eluting balloon: is it useful?The Egyptian heart journal : (EHJ) : official bulletin of the Egyptian Society of Cardiology · 2020
    Review
  11. Article
  12. Observational
  13. Observational
  14. Observational
  15. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors.

Marcus WiemerDepartment of Cardiology and Intensive Care Medicine, Johannes Wesling University Hospital, Ruhr University Bochum, Hans-Nolte-Str. 1, 32429, Minden, Germany. marcus.wiemer@muehlenkreiskliniken.de.
Sinisa StoikovicClinic for Cardiology, Clinical Center of Serbia, School of Medicine, University of Belgrade, Belgrade, Serbia.
Alexander SamolDepartment of Cardiology and Intensive Care Medicine, Johannes Wesling University Hospital, Ruhr University Bochum, Hans-Nolte-Str. 1, 32429, Minden, Germany.
Zisis DimitriadisDepartment of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum, Bad Oeynhausen, Germany.
Juan M Ruiz-NodarHospital General Universitario de Alicante, Universidad Miguel Hernández, Alicante, Spain.
Ralf BirkemeyerHerzklinik Ulm, Ulm, Germany.
Jacques MonseguGroupe Hospitalier Mutualiste de Grenoble, Grenoble, France.
Gérard FinetHospital Cardiovasculaire Louis Pradel, Bron, France.
David Hildick-SmithSussex Cardiac Centre, Brighton and Sussex University Hospitals, Brighton, UK.
Damras TresukosolSiriraj Hospital, Bangkok, Thailand.
Enrique Garcia NovoHospital Guadalajara, Guadalajara, Spain.
Jacques J KoolenSt. Catharina Eindhoven, Eindhoven, The Netherlands.
Emanuele BarbatoCardiovascular Research Center Aalst, OLV Hospital, Aalst, Belgium.
Gian Battista DanziOspedale Santa Corona, Pietra Ligure, Italy.
NOBORI 2 investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo report the long-term safety and efficacy data of a third generation drug eluting stent (DES) with biodegradable polymer in the complex patient population of diabetes mellitus after a follow-up period of 5 years.

backgroundAfter percutaneous coronary intervention patients with diabetes mellitus are under higher risk of death, restenosis and stent thrombosis (ST) compared to non-diabetic patients.

methodsIn 126 centers worldwide 3067 patients were enrolled in the NOBORI 2 registry, 888 patients suffered from diabetes mellitus (DM), 213 of them (14%) being insulin dependent (IDDM). Five years follow-up has been completed in this study.

resultsAt 5 years, 89.3% of the patients were available for follow-up. The reported target lesion failure (TLF) rates at 5 years were 12.39% in DM group and 7.34% in non-DM group; (p < 0.0001). In the DM group, the TLF rate in patients with IDDM was significantly higher than in the non-IDDM subgroup (17.84 vs. 10.67%; p < 0.01). The rate of ST at 5 years was not different among diabetic versus non-diabetic patients or IDDM versus NIDDM. Only 10 (<0.4%) very late stent thrombotic events beyond 12 months occurred.

conclusionsThe Nobori DES performed well in patients with DM. As expected patients with DM, particularly those with IDDM, had worse outcomes. However, the very low rate of very late stent thrombosis in IDDM patients might have significant clinical value in the treatment of these patients. Clinical trial registration ISRCTN81649913; http://www.controlled-trials.com/isrctn/search.html?srch=81649913&sort=3&dir=desc&max=10.

Indexed as

Absorbable ImplantsDrug-Eluting StentsAgedCoronary Artery DiseaseCoronary RestenosisCoronary ThrombosisDiabetes MellitusFemaleHumansHypoglycemic AgentsInsulinKaplan-Meier EstimateMaleMiddle AgedPercutaneous Coronary InterventionPlatelet Aggregation InhibitorsHypoglycemic AgentsInsulinPlatelet Aggregation InhibitorsPolymers

Identifiers

PMID28183306
PMCPMC5301341

What OpenQuestion holds

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Registered trials

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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.