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)
2026年9月3日 更新者：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.
研究概览
地位
招聘中
研究类型
观察性的
注册 (估计的)
668
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Yuan He, MD, PhD
- 电话号码：+86-13991854483
- 邮箱：heyuan820927@163.com
学习地点
-
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Shaanxi
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Xi'an、Shaanxi、中国、710032
- 招聘中
- First Affiliated Hospital of Fourth Military Medical University
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接触：
- Yuan He, MD, PhD
- 电话号码：+86-13991854483
- 邮箱：heyuan820927@163.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
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.
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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.
|
|
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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of immediate slow-flow or no-reflow after PCI
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient-oriented Composite Endpoint (PoCE) at 1-year follow-up
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年1月1日
初级完成 (估计的)
2027年6月30日
研究完成 (估计的)
2028年1月31日
研究注册日期
首次提交
2026年9月1日
首先提交符合 QC 标准的
2026年9月3日
首次发布 (实际的)
2026年9月8日
研究记录更新
最后更新发布 (实际的)
2026年9月8日
上次提交的符合 QC 标准的更新
2026年9月3日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- KY20262334-C-1
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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