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NCT Number: NCT07806370

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

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.

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Key information

Conditions

ST Elevation Myocardial Infarction (STEMI) Acute Coronary Syndrome Acute Coronary Syndromes (ACS) Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital of Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location status: Recruiting

Location contact

Yuan He, MD, PhD

CONTACT

[email protected]

+86-13991854483

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Angiographic thrombus grade of the culprit vessel is G2-G4.
  • Reference vessel diameter of the culprit vessel: 2.25-4.0 mm.
  • Complete pre-procedural and post-procedural coronary angiographic imaging data are available.
  • Age ≥ 18 years old.

Exclusion criteria

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

Treatment and study plan

Drug-coated balloon (DCB)

Device

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)

Device

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.

Primary outcomes

  1. Incidence of immediate slow-flow or no-reflow after PCI

    Time frame: 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.

Secondary outcomes

  1. Patient-oriented Composite Endpoint (PoCE) at 1-year follow-up

    Time frame: 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.

  2. Incidence of Patient-oriented Composite Endpoint (PoCE) at 1-year follow-up

    Time frame: 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.

  3. Individual components of PoCE at 1-year follow-up

    Time frame: 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.

  4. Device-oriented Composite Endpoint (DoCE) at 1-year follow-up

    Time frame: 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.

  5. Individual components of DoCE at 1-year follow-up

    Time frame: 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).

  6. Target Vessel Failure (TVF) at 1-year follow-up

    Time frame: 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.

  7. Clinically-driven target-vessel revascularization at 1-year follow-up

    Time frame: 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.

  8. Net Adverse Clinical Events (NACE) at 1-year follow-up

    Time frame: 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.

  9. BARC type 3 or 5 bleeding events at 1-year follow-up

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yuan He, MD, PhD

CONTACT

[email protected]

+86-13991854483

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Acronym: STEMI-DCB

Important dates

Study start
2019
Primary completion
2027
Study completion
2028
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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