Acute Coronary Syndromes (ACS), ST Elevation Myocardial Infarction (STEMI)
Conditions
Keywords
High thrombus burden, Drug-coated balloon, Drug-eluting stent
Brief summary
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.
Interventions
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.
DEVICEDrug-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.
Sponsors
Xijing Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of immediate slow-flow or no-reflow after PCI | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient-oriented Composite Endpoint (PoCE) at 1-year follow-up | 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. |
| Incidence of Patient-oriented Composite Endpoint (PoCE) at 1-year follow-up | 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. |
| Individual components of PoCE at 1-year follow-up | 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. |
| Device-oriented Composite Endpoint (DoCE) at 1-year follow-up | 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. |
| Individual components of DoCE at 1-year follow-up | 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). |
| Target Vessel Failure (TVF) at 1-year follow-up | 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. |
| Clinically-driven target-vessel revascularization at 1-year follow-up | 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. |
| Net Adverse Clinical Events (NACE) at 1-year follow-up | 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. |
| BARC type 3 or 5 bleeding events at 1-year follow-up | 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. |
Countries
China
Contacts
CONTACTYuan He, MD, PhD
Outcome results
None listed