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)
2026년 9월 3일 업데이트: 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.
연구 개요
상태
모병
연구 유형
관찰
등록 (추정된)
668
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Yuan He, MD, PhD
- 전화번호: +86-13991854483
- 이메일: heyuan820927@163.com
연구 장소
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Shaanxi
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Xi'an, Shaanxi, 중국, 710032
- 모병
- First Affiliated Hospital of Fourth Military Medical University
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연락하다:
- Yuan He, MD, PhD
- 전화번호: +86-13991854483
- 이메일: heyuan820927@163.com
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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
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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.
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|
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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of immediate slow-flow or no-reflow after PCI
기간: Immediately after the index emergency PCI procedure
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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.
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Immediately after the index emergency PCI procedure
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient-oriented Composite Endpoint (PoCE) at 1-year follow-up
기간: 1 year after index emergency PCI procedure
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Composite endpoint of all-cause death, non-fatal myocardial infarction, stroke, and any revascularization within 1-year after index emergency PCI.
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1 year after index emergency PCI procedure
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Incidence of Patient-oriented Composite Endpoint (PoCE) at 1-year follow-up
기간: 1 year after index emergency PCI procedure
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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.
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1 year after index emergency PCI procedure
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Individual components of PoCE at 1-year follow-up
기간: 1 year after index emergency PCI procedure
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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.
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1 year after index emergency PCI procedure
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Device-oriented Composite Endpoint (DoCE) at 1-year follow-up
기간: 1 year after index emergency PCI procedure
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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.
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1 year after index emergency PCI procedure
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Individual components of DoCE at 1-year follow-up
기간: 1 year after index emergency PCI procedure
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Incidence of each separate component event of DoCE: cardiac death, target-vessel myocardial infarction (TV-MI), clinically-driven target-lesion revascularization (CI-TLR).
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1 year after index emergency PCI procedure
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Target Vessel Failure (TVF) at 1-year follow-up
기간: 1 year after index emergency PCI procedure
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Composite of cardiac death, target-vessel myocardial infarction, and clinically-driven target-vessel revascularization within 1-year after index emergency PCI.
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1 year after index emergency PCI procedure
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Clinically-driven target-vessel revascularization at 1-year follow-up
기간: 1 year after index emergency PCI procedure
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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
기간: 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
기간: 1 year after index emergency PCI procedure
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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
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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2019년 1월 1일
기본 완료 (추정된)
2027년 6월 30일
연구 완료 (추정된)
2028년 1월 31일
연구 등록 날짜
최초 제출
2026년 9월 1일
QC 기준을 충족하는 최초 제출
2026년 9월 3일
처음 게시됨 (실제)
2026년 9월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 3일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- KY20262334-C-1
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .