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A Single-Center, Retrospective, Propensity-Score-Matched Cohort Study Comparing Drug-Coated Balloon Versus Drug-Eluting Stent for Reducing Immediate Post-Procedural Slow-Flow/No-Reflow in Acute ST-Elevation Myocardial Infarction Patients With High Thrombus Burden (STEMI-DCB)

3. september 2026 opdateret af: Yuan He, MD, Xijing Hospital

Comparison Of Drug-Coated Balloon Versus Drug-Eluting Stent In STEMI Patients With High Thrombus Burden: A Single-Center Retrospective Study Using Propensity Score Matching

This is a single-center, retrospective, propensity-score-matched observational study. It aims to compare the rate of immediate slow-flow or no-reflow after percutaneous coronary intervention (PCI) between drug-coated balloon (DCB) and drug-eluting stent (DES) in STEMI patients with high thrombus burden. Medical records of eligible patients admitted between January 1, 2019 and June 30, 2025 will be reviewed. Propensity-score matching will be used to balance baseline characteristics of the two groups. Both procedural-related outcomes and 1-year clinical follow-up events will be analyzed.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

668

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Shaanxi
      • Xi'an, Shaanxi, Kina, 710032
        • Rekruttering
        • First Affiliated Hospital of Fourth Military Medical University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

This is a single-center retrospective observational study. The study population consists of patients diagnosed with ST-elevation myocardial infarction (STEMI) with high thrombus burden (angiographic thrombus grade G2-G4) who underwent emergency percutaneous coronary intervention (PCI) at Xijing Hospital between January 1, 2019 and June 30, 2025. Eligible patients received either drug-coated balloon (DCB) or drug-eluting stent (DES) as the final revascularization strategy for the culprit vessel. Patients are identified from in-hospital medical records and coronary angiographic databases.

Beskrivelse

Inclusion Criteria:

  1. Patients diagnosed with ST-elevation myocardial infarction (STEMI) undergoing emergency percutaneous coronary intervention (PCI) at this center:

    • Symptom onset ≤ 12 hours; OR
    • Symptom onset > 12 hours with persistent ischemic symptoms.
  2. Angiographic thrombus grade of the culprit vessel is G2-G4.
  3. Reference vessel diameter of the culprit vessel: 2.25-4.0 mm.
  4. Complete pre-procedural and post-procedural coronary angiographic imaging data are available.
  5. Age ≥ 18 years old.

Exclusion Criteria:

  1. Participation in other clinical trials.
  2. Cardiogenic shock or post-cardiac-arrest resuscitation state.
  3. Multi-vessel coronary artery disease.
  4. Severe calcified lesions requiring rotational atherectomy or shock-wave therapy.
  5. Only compliant or non-compliant plain balloon dilation performed.
  6. Both DES and DCB applied to the same culprit vessel.
  7. Culprit lesion located in a coronary bypass graft, or in-stent restenosis / in-stent thrombosis.
  8. Missing key angiographic or clinical follow-up data.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Drug-Coated Balloon (DCB) Cohort
STEMI patients with high thrombus burden who received drug-coated balloon (DCB) as the final revascularization strategy for culprit coronary vessel
Enhed: Drug-Coated Balloon (DCB)
A drug-coated balloon catheter used for percutaneous coronary intervention in patients with STEMI and high thrombus burden. The balloon surface is coated with an antiproliferative drug (e.g., paclitaxel) that is transferred to the vessel wall during balloon inflation, inhibiting neointimal hyperplasia. No permanent metal scaffold is implanted after DCB-only revascularization.
Drug-Eluting Stent (DES) Cohort
STEMI patients with high thrombus burden who received drug-eluting stent (DES) implantation as the final revascularization strategy for culprit coronary vessel, including bailout DES implantation after DCB.
Enhed: Drug-Eluting Stent (DES)
A permanent coronary metal scaffold coated with an antiproliferative drug (e.g., sirolimus, everolimus, zotarolimus, or biolimus) implanted during percutaneous coronary intervention. The stent maintains vessel patency and the eluted drug inhibits neointimal hyperplasia. Used for culprit-vessel revascularization in STEMI patients with high thrombus burden, including bailout DES implantation after DCB predilation.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of immediate slow-flow or no-reflow after PCI
Tidsramme: Immediately after the index emergency PCI procedure
The incidence of immediate slow-flow or no-reflow phenomenon after percutaneous coronary intervention (PCI) with either drug-coated balloon (DCB) or drug-eluting stent (DES). Slow-flow/no-reflow is defined as TIMI flow grade ≤2 after the procedure in the absence of mechanical obstruction, dissection, or severe spasm.
Immediately after the index emergency PCI procedure

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient-oriented Composite Endpoint (PoCE) at 1-year follow-up
Tidsramme: 1 year after index emergency PCI procedure
Composite endpoint of all-cause death, non-fatal myocardial infarction, stroke, and any revascularization within 1-year after index emergency PCI.
1 year after index emergency PCI procedure
Incidence of Patient-oriented Composite Endpoint (PoCE) at 1-year follow-up
Tidsramme: 1 year after index emergency PCI procedure
The overall incidence of Patient-oriented Composite Endpoint (PoCE) within 1-year after index emergency PCI. PoCE is defined as a composite of all-cause death, non-fatal myocardial infarction, stroke, and any revascularization. This endpoint is assessed through in-hospital medical records, outpatient follow-up records, and telephone follow-up data.
1 year after index emergency PCI procedure
Individual components of PoCE at 1-year follow-up
Tidsramme: 1 year after index emergency PCI procedure
Incidence of each separate component event of PoCE: all-cause death, non-fatal myocardial infarction, stroke, any revascularization. This endpoint is assessed through in-hospital medical records, outpatient follow-up records, and telephone follow-up data.
1 year after index emergency PCI procedure
Device-oriented Composite Endpoint (DoCE) at 1-year follow-up
Tidsramme: 1 year after index emergency PCI procedure
Composite of cardiac death, target-vessel myocardial infarction (TV-MI), and clinically-driven target-lesion revascularization (CI-TLR) within 1-year after index emergency PCI.
1 year after index emergency PCI procedure
Individual components of DoCE at 1-year follow-up
Tidsramme: 1 year after index emergency PCI procedure
Incidence of each separate component event of DoCE: cardiac death, target-vessel myocardial infarction (TV-MI), clinically-driven target-lesion revascularization (CI-TLR).
1 year after index emergency PCI procedure
Target Vessel Failure (TVF) at 1-year follow-up
Tidsramme: 1 year after index emergency PCI procedure
Composite of cardiac death, target-vessel myocardial infarction, and clinically-driven target-vessel revascularization within 1-year after index emergency PCI.
1 year after index emergency PCI procedure
Clinically-driven target-vessel revascularization at 1-year follow-up
Tidsramme: 1 year after index emergency PCI procedure
Revascularization of target vessel triggered by clinical symptoms or myocardial ischemia evidence within 1-year after index emergency PCI.
1 year after index emergency PCI procedure
Net Adverse Clinical Events (NACE) at 1-year follow-up
Tidsramme: 1 year after index emergency PCI procedure
Composite of PoCE plus BARC-defined type 3 or 5 bleeding events within 1-year after index emergency PCI.
1 year after index emergency PCI procedure
BARC type 3 or 5 bleeding events at 1-year follow-up
Tidsramme: 1 year after index emergency PCI procedure
Bleeding events meeting BARC (Bleeding Academic Research Consortium) type 3 or type 5 criteria within 1-year after index emergency PCI.
1 year after index emergency PCI procedure

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Xijing Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2019

Primær færdiggørelse (Anslået)

30. juni 2027

Studieafslutning (Anslået)

31. januar 2028

Datoer for studieregistrering

Først indsendt

1. september 2026

Først indsendt, der opfyldte QC-kriterier

3. september 2026

Først opslået (Faktiske)

8. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KY20262334-C-1

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual-level patient data will not be shared due to patient privacy protection requirements and local hospital data management regulations. This is a single-center retrospective study based on historical medical records. No formal data sharing mechanism has been established. Aggregated study results may be published in peer-reviewed journals.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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