Evidence map›Paper›PMID 38310281›Full record

ArticleCardiovascular diabetology2024

Sirolimus-coated balloon in all-comer population of coronary artery disease patients: the EASTBOURNE DIABETES prospective registry.

Gianluca Caiazzo, Angelo Oliva, Luca Testa, Tay M Heang, Chuey Y Lee, Diego Milazzo, Giulio Stefanini, Nicola Pesenti, Antonio Mangieri, Antonio Colombo and 2 more

Abstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Cardiovascular diabetology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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

10 citing papers in PubMed.

  1. Observational
  2. Review
  3. Article
  4. Review
  5. Drug-coated balloons and diabetes: a review.Cardiovascular diabetology · 2025
    Review
  6. Differential clinical outcomes in ACS: the amplified risk of diabetes in patients treated with drug-coated balloon angioplasty.The Egyptian heart journal : (EHJ) : official bulletin of the Egyptian Society of Cardiology · 2025
    Article
  7. Review
  8. Article
  9. Review
  10. 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

12 authors.

Gianluca Caiazzo *U.O.C. UTIC-Cardiologia, P.O. San Giuseppe Moscati - Aversa - ASL Caserta, Aversa, Italy.
Angelo Oliva *Department of Biomedical Sciences, Humanitas University, Pieve Emanuele-Milan, Italy.
Luca TestaIRCCS Policlinico San Donato, Milano, Italy.
Tay M HeangPantai Hospital Ayer Keroh, Melaka, Malaysia.
Chuey Y LeeSultanah Aminah Hospital Johor Bahru, Johor bahru, Malaysia.
Diego MilazzoASP S. Giovanni di Dio, Agrigento, Italy.
Giulio StefaniniDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele-Milan, Italy.
Nicola PesentiDepartment of Statistics and Quantitative Methods, Division of Biostatistics, Epidemiology, and Public Health, University of Milano-Bicocca, Milano, Italy.
Antonio MangieriDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele-Milan, Italy.
Antonio ColomboDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele-Milan, Italy.
Bernardo CorteseWe 4 Clinical Research, Milano, Italy. bcortese@gmail.com.
EASTBOURNE investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe outcomes of percutaneous coronary intervention (PCI) in diabetic patients are still suboptimal, and it is unclear if diabetic patients might derive a benefit from the use of drug-coated balloons.

aimsTo evaluate the impact of diabetes mellitus on the outcomes of patients undergoing PCI with sirolimus-coated balloon (SCB) MagicTouch (Concept Medical, India).

methodsWe conducted a subgroup analysis of the prospective, multicenter, investigator-initiated EASTBOURNE registry, evaluating the performance of MagicTouch SCB in patients with and without diabetes. The study primary endpoint was target lesion revascularization (TLR) at 12-month follow-up. Secondary clinical endpoints were major adverse clinical events (MACE), death, myocardial infarction (MI), and BARC 2-5 bleedings.

resultsAmong 2,083 enrolled patients, a total of 864 suffered from diabetes (41.5%). Patients with diabetes had a numerically higher occurrence of TLR (6.5% vs. 4.7% HR 1.38, 95%CI 0.91-2.08), all-cause death (3.8% vs. 2.6%, HR 1.81, 95%CI 0.95-3.46), and MACE (12.2% vs. 8.9%; HR 1.26 95%CI 0.92-1.74). The incidence of spontaneous MI was significantly higher among diabetic patients (3.4% vs. 1.5%, HR 2.15 95%CI 1.09-4.25); bleeding events did not significantly differ. The overall incidence of TLR was higher among in-stent restenosis (ISR) as compared to de-novo coronary lesions, irrespectively from diabetes status.

conclusionsIn the EASTBOURNE DIABETES registry, diabetic patients treated with the MagicTouch SCB did not have a significant increase in TLR when compared to non-diabetic patients; moreover, diabetic status did not affect the study device performance in terms of TLR, in both de-novo lesions and ISR.

Indexed as

Coronary Artery DiseaseCoronary RestenosisDiabetes MellitusMyocardial InfarctionPercutaneous Coronary InterventionHumansRegistriesSirolimusTreatment OutcomeSirolimusCoronary artery diseaseDiabetes mellitusDrug-coated balloon

Identifiers

PMID38310281
PMCPMC10838457

What Socratic holds

Textmetadata
LicenceCC BY
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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 Socratic graph.