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)

September 3, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

668

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • First Affiliated Hospital of Fourth Military Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Device: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after the index emergency PCI procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year after index emergency PCI procedure
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.
1 year after index emergency PCI procedure
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.
1 year after index emergency PCI procedure
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.
1 year after index emergency PCI procedure
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).
1 year after index emergency PCI procedure
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.
1 year after index emergency PCI procedure
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.
1 year after index emergency PCI procedure
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.
1 year after index emergency PCI procedure
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.
1 year after index emergency PCI procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

September 1, 2026

First Submitted That Met QC Criteria

September 3, 2026

First Posted (Actual)

September 8, 2026

Study Record Updates

Last Update Posted (Actual)

September 8, 2026

Last Update Submitted That Met QC Criteria

September 3, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20262334-C-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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