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

NCT07806370 | Recruiting

• 1 other identifier: KY20262334-C-1
• Study Type: observational
• Target: 668
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

High thrombus burden; Drug-coated balloon; Drug-eluting stent

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately after the index emergency PCI procedure

Secondary Outcomes (9)

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

  1 year after index emergency PCI procedure

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

  1 year after index emergency PCI procedure

• Individual components of PoCE at 1-year follow-up

  1 year after index emergency PCI procedure

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

  1 year after index emergency PCI procedure

• Individual components of DoCE at 1-year follow-up

  1 year after index emergency PCI procedure

Study Arms (2)

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)

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)

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.

Drug-Coated Balloon (DCB) Cohort

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.

Drug-Eluting Stent (DES) Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

First Affiliated Hospital of Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

Related Publications (2)

• Cenko E, Badimon L, Vadala G, Merkus D, Antoniades C, Collet C, De Maria GL, Djordjevic-Dikic A, Drenjancevic I, Escaned J, Ferreiro JL, Fleming I, Guzik T, Manfrini O, Milicic D, Padro T, Porto I, Riou LM, Ryan N, Tousoulis D, van Beusekom HMM, Vavlukis M, Vilahur G, Zdravkovic M, Duncker DJ, Galassi AR, Bugiardini R; ESC EAPCI Document Reviewers: Gianluca Campo (Italy), and Felix Mahfoud (Switzerland). Pathophysiology, prevention, and management of coronary microvascular obstruction. Eur Heart J. 2026 Aug 14;47(31):4215-4241. doi: 10.1093/eurheartj/ehag334.

  PMID: 42185090 RESULT

• Vos NS, Fagel ND, Amoroso G, Herrman JR, Patterson MS, Piers LH, van der Schaaf RJ, Slagboom T, Vink MA. Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction: The REVELATION Randomized Trial. JACC Cardiovasc Interv. 2019 Sep 9;12(17):1691-1699. doi: 10.1016/j.jcin.2019.04.016. Epub 2019 May 21.

  PMID: 31126887 RESULT

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Acute Coronary Syndrome

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Central Study Contacts

Yuan He, MD, PhD

CONTACT

+86-13991854483; heyuan820927@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 8, 2026
• Study Start: January 1, 2019
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)