Non-stenting Treatment Strategy for Acute Myocardial Infarction With Non-severe Stenosis(EROSION IV)

Non-stenting Treatment Strategy for Acute Myocardial Infarction With Non-severe Stenosis: a Prospective, Multicenter, Open-label, Non-inferiority, Randomised Controlled Trial(EROSION IV)

This study is a prospective, multicenter, open-label, non-inferiority, randomized controlled trial. A total of 2,000 patients with STEMI (<24 hours or 7-14 days) or NSTEMI will be recruited from at least 20 centers in China. Eligible patients must have residual DS < 70% at the culprit lesion assessed by QCA, with optional thrombus aspiration, and TIMI flow of grade 3. Patients will be randomly assigned in a 1:1 ratio to the experimental group or the control group. The planned enrollment period is 36 months, and all patients will be followed up for at least 12 months after randomization, with continued follow-up until the end of the study. The primary outcome is the first occurrence of TLF after randomization, defined as the composite of cardiovascular death, target vessel myocardial infarction, ischemia-driven target lesion revascularization. The study aims to verify whether guideline-recommended standard medical therapy is non-inferior to DES implantation combined with guideline-recommended standard medical therapy in AMI patients with non-severe coronary artery stenosis.

A total of 120 participants (60 in the experimental group and 60 in the control group) enrolled at the Second Affiliated Hospital of Harbin Medical University were included in the functional substudy. Using Abbott Pressure Wire™X pressure wire test functional indicators, and explore the incidence of coronary microvascular dysfunction (CMD) as assessed by the index of microcirculatory resistance (IMR) in two groups, and its impact on the rate of the composite endpoint of all-cause death and heart failure readmission occurring for the first time within 12 months.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Myocardial Infarction (AMI); ST-Segment Elevation Myocardial Infarction(STEMI); Non-ST-Segment Elevation Myocardial Infarction(NSTEMI)
• Intervention / Treatment: Drug: Guideline-recommended standard medical therapy alone; Procedure: DES implantation plus guideline-recommended standard medical therapy

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jingbo Hou, Ph.D.; Phone Number: 13303609625; Email: jingbohou@163.com
• Study Contact Backup: Name: Bo Yu, Ph.D.; Email: yubodr@163.com

Study Locations

• China
  • Beijing, China
    • Fuwai Hospital, Chinese Academy of Medical Sciences
    • Contact: Lei Song
  • Beijing, China
    • Beijing Luhe Hospital Affiliated to Capital Medical University
    • Contact: Guangyao Zhai
  • Cangzhou, China
    • Cangzhou Central Hospital
    • Contact: Jun Zhang
  • Chengde, China
    • Chengde Medical College Affiliated Hospital
    • Contact: Ying Zhang
  • Chengdu, China
    • Sichuan Provincial People's Hospital
  • Dalian, China
    • The Second Affiliated Hospital of Dalian Medical University
    • Contact: Xin Zhao
  • Dalian, China
    • The First Affiliated Hospital of Dalian Medical University
  • Dalian, China
    • The Central Hospital Affiliated to Dalian University of Technology
    • Contact: Xiaoqun Zheng
  • Daqing, China
    • Daqing Oilfield General Hospital
    • Contact: Zhiqi Sun
  • Harbin, China
    • The Fourth Affiliated Hospital of Harbin Medical University
  • Hunan, China
    • The third xiangya hospital of Central South University
    • Contact: Yu Cao
  • Jiamusi, China
    • Central Hospital of Jiamusi City
  • Jiamusi, China
    • The First Affiliated Hospital of Jiamusi University
    • Contact: Guangyuan Yang
  • Jilin, China
    • China-Japan Union Hospital of Jilin University
    • Contact: Yuquan He
  • Jilin, China
    • the First Hospital of Jilin University
    • Contact: Qian Tong
  • Jilin, China
    • Jilin Central Hospital
    • Contact: Yijun Shang
  • Jinan, China
    • Shandong Provincial Hospital
  • Jining, China
    • The Affiliated Hospital of Jining Medical University
    • Contact: Lijun Gan
  • Lanzhou, China
    • Lanzhou University First Hospital
  • Linyi, China
    • Linyi people's hospital
    • Contact: Yanjin Wei
  • Mudanjiang, China
    • Mudanjiang Cardiovascular Hospital
    • Contact: Kai Liu
  • Nanyang, China
    • The First Affiliated Hospital of Nanyang Medical College
    • Contact: Ou Zhang
  • Qingdao, China
    • The Affiliated Hospital Of Qingdao University
    • Contact: Zhexun Lian
  • Qiqihar, China
    • Qiqihar First Hospital
    • Contact: Jinhui Zhang
  • Qiqihar, China
    • The Second Affiliated Hospital of Qiqihar Medical University
  • Qiqihar, China
    • The Third Affiliated Hospital of Qiqihar Medical University
  • Shenyang, China
    • Shengjing Hospital of China Medical University
    • Contact: Zhijun Sun
  • Shenyang, China
    • Liaoning Provincial People's Hospital
    • Contact: Bo Luan
  • Shenyang, China
    • The fourth Affiliated Hospital of China Medical University
    • Contact: Yuanzhe Jin
  • Shijia Zhuang, China
    • The Second Hospital of Hebei Medical University
  • Shijiazhuang, China
    • Hebei Provincial People's Hospital
    • Contact: Yi Dang
  • Suihua, China
    • Suihua First Hospital
    • Contact: Qiuye Yang
  • Taiyuan, China
    • General Hospital of Taiyuan Iron and Steel (Group) Co.
  • Taiyuan, China
    • Shanxi Provincial Cardiovascular Hospital
    • Contact: Zhulin Zhang
  • Tianjin, China
    • General Hospital of Tianjin Medical University
    • Contact: Qing Yang
  • Tianjin, China
    • Tianjin Chest Hospital
    • Contact: Chunjie Li
  • Tianjin, China
    • Teda International Cardiovascular Hospital
    • Contact: Wenhua Lin
  • Wenzhou, China
    • The Second Affiliated Hospital of Wenzhou Medical University
    • Contact: Xueqiang Guan
  • Wuhan, China
    • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    • Contact: Xiang Cheng
  • Wuhan, China
    • Wuhan Asia Heart Hospital
    • Contact: Hua Yan
  • Xi'an, China
    • The First Affiliated Hospital of Xi'an Jiaotong University
  • Xinjiang, China
    • The First Affiliated Hospital of Xinjiang Medical University
    • Contact: Xiang Ma
  • Xinjiang, China
    • People's Hospital of Xinjiang Uygur Autonomous Region
  • Yantai, China
    • Yantai Yuhuangding Hospital
  • Zhengzhou, China
    • The First Affiliated Hospital of Zhengzhou University
    • Contact: Jinying Zhang
  • Zhengzhou, China
    • Fuwai Huazhong Cardiovascular Hospital
  • Zunyi, China
    • Zunyi Medical University Affiliated Hospital
    • Contact: Ranzun Zhao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female patients aged ≥18 years and ≤75 years;
2. Diagnosis of type 1 AMI, including STEMI (onset <24 hours or 7-14 days) or NSTEMI;
3. After coronary angiography (CAG) ± thrombus aspiration, TIMI flow in the culprit vessel is restored to grade 3 and maintained for at least 5 minutes, with diameter stenosis (DS) <70% at the culprit lesion (QCA);
4. Reference diameter of the culprit lesion >2.5 mm and ≤4.0 mm;
5. Patients or a legally authorized representative must provide written Informed Consent prior to any study related procedure.

Exclusion Criteria:

1.Clinical exclusion criteria:

1. Severe cardiac dysfunction (Killip/NYHA class ≥ 3) or LVEF < 30%;
2. Cardiopulmonary resuscitation (CPR) performed at the onset of AMI;
3. Persistent hemodynamic or cardiac electrical instability after TIMI flow restoration;
4. Contraindication to antithrombotic drugs, or concurrent hemorrhagic diseases such as peptic ulcer or coagulation disorders;
5. Contraindication to contrast;
6. Severe renal dysfunction [defined as eGFR ≤30 ml/min/1.73m² or Scr ≥2.0 mg/dL] without regular dialysis (patients with chronic renal insufficiency on regular dialysis may be considered for enrollment);
7. Active liver disease, defined as known infectious, neoplastic, or metabolic liver lesions, with ALT and AST >3× upper limit of normal (ULN);
8. Previous history of CABG or PCI for the culprit lesion;
9. Patients with other concurrent severe diseases and an expected life expectancy of <1 year;
10. Pregnant or lactating women. Women of childbearing potential must use effective contraceptive measures during the study treatment period;
11. Inability to comply with the study protocol or other conditions deemed unsuitable for study participation by the investigator.

2.Imaging exclusion criteria:

1. Non-culprit lesion with DS ≥70% or planned revascularization;
2. Left main coronary artery lesion with DS ≥50%;
3. Culprit lesion is a true bifurcation lesion requiring a two-stent strategy;
4. Long lesion (planned stent length >60 mm);
5. Culprit lesion with dissection, false lumen, or other conditions necessitating stent implantation;
6. Target lesion has undergone pre-treatment (such as balloon dilation, rotational atherectomy, etc.).

3.Functional sub study:

1. Individuals who are allergic to adenosine triphosphate (ATP) or any component in its preparations;
2. Second and third degree atrioventricular block, sick sinus syndrome (without artificial pacemaker protectors);
3. Patients with bronchial asthma.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Guideline-recommended standard medical therapy alone; Dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction.	Drug: Guideline-recommended standard medical therapy alone; Dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction
Active Comparator: DES implantation plus guideline-recommended standard medical therapy; DES implantation plus dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction.	Procedure: DES implantation plus guideline-recommended standard medical therapy; DES implantation plus dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Failure(TLF)	TLF is defined as a composite endpoint consisting of cardiovascular death, target vessel myocardial infarction and ischemia-driven target lesion revascularization.	From randomization to the end of the study, median follow-up duration is 30 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause death		From randomization to the end of the study, median follow-up duration is 30 months.
Cardiovascular death		From randomization to the end of the study, median follow-up duration is 30 months.
Myocardial infarction (MI)		From randomization to the end of the study, median follow-up duration is 30 months.
Target vessel myocardial infarction		From randomization to the end of the study, median follow-up duration is 30 months.
Coronary Revascularization		From randomization to the end of the study, median follow-up duration is 30 months.
Target vessel revascularization		From randomization to the end of the study, median follow-up duration is 30 months.
Target lesion revascularization		From randomization to the end of the study, median follow-up duration is 30 months.
Ischemia-driven target lesion revascularization		From randomization to the end of the study, median follow-up duration is 30 months.
Stroke		From randomization to the end of the study, median follow-up duration is 30 months.
Rehospitalization for unstable angina pectoris		From randomization to the end of the study, median follow-up duration is 30 months.
Rehospitalization for heart failure		From randomization to the end of the study, median follow-up duration is 30 months.
Major adverse cardiovascular and cerebrovascular events (MACCE)	MACCE: defined as a composite endpoint consisting of all-cause death, myocardial infarction, stroke, and repeat revascularization.	From randomization to the end of the study, median follow-up duration is 30 months.
Seattle Angina Questionnaire(SAQ)score		From 24 hours after surgery to discharge and the 12th month after discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Definite or probable in-stent thrombosis	Safety endpoint	From randomization to the end of the study, median follow-up duration is 30 months.
Contrast-induced acute kidney injury(CI-AKI)	Safety endpoint	From randomization to the end of the study, median follow-up duration is 30 months.
Procedure-related myocardial infarction	Safety endpoint	From randomization to the end of the study, median follow-up duration is 30 months.
Bleeding Academic Research Consortium(BARC)type 3 and type 5 bleeding	Safety endpoint	From randomization to the end of the study, median follow-up duration is 30 months.
Microcirculation resistance index(IMR)to assess the incidence of coronary microvascular dysfunction (CMD)	Exploratory endpoint:Functional sub research	From randomization to the end of the study, median follow-up duration is 30 months.
The first occurrence of all-cause death and readmission due to heart failure within 12 months.	Exploratory endpoint:Functional sub research	From randomization to the 12th month.

Collaborators and Investigators

• Sponsor: Harbin Medical University
• Investigators: Principal Investigator: Bo Yu, Ph.D., The Second Affiliated Hospital of Harbin Medical University; Principal Investigator: Jingbo Hou, Ph.D., The Second Affiliated Hospital of Harbin Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: OCT; AMI; TLF; DES; IMR
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Pathological Conditions, Signs and Symptoms; ST Elevation Myocardial Infarction
• Other Study ID Numbers: KY2026-042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No