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

Xijing Hospital668 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

668

Conditions

ST Elevation Myocardial Infarction (STEMI)Acute Coronary Syndromes (ACS)

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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.

Time frame: Immediately after the index emergency PCI procedure

Secondary Outcomes

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

Composite endpoint of all-cause death, non-fatal myocardial infarction, stroke, and any revascularization within 1-year after index emergency PCI.