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)
3 september 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Beräknad)
668
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Yuan He, MD, PhD
- Telefonnummer: +86-13991854483
- E-post: heyuan820927@163.com
Studieorter
-
-
Shaanxi
-
Xi'an, Shaanxi, Kina, 710032
- Rekrytering
- First Affiliated Hospital of Fourth Military Medical University
-
Kontakt:
- Yuan He, MD, PhD
- Telefonnummer: +86-13991854483
- E-post: heyuan820927@163.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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
|
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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of immediate slow-flow or no-reflow after PCI
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Patient-oriented Composite Endpoint (PoCE) at 1-year follow-up
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
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Target Vessel Failure (TVF) at 1-year follow-up
Tidsram: 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
|
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Clinically-driven target-vessel revascularization at 1-year follow-up
Tidsram: 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.
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1 year after index emergency PCI procedure
|
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Net Adverse Clinical Events (NACE) at 1-year follow-up
Tidsram: 1 year after index emergency PCI procedure
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Composite of PoCE plus BARC-defined type 3 or 5 bleeding events within 1-year after index emergency PCI.
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1 year after index emergency PCI procedure
|
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BARC type 3 or 5 bleeding events at 1-year follow-up
Tidsram: 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.
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1 year after index emergency PCI procedure
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 januari 2019
Primärt slutförande (Beräknad)
30 juni 2027
Avslutad studie (Beräknad)
31 januari 2028
Studieregistreringsdatum
Först inskickad
1 september 2026
Först inskickad som uppfyllde QC-kriterierna
3 september 2026
Första postat (Faktisk)
8 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
8 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- KY20262334-C-1
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
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Nej
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Nej
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