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

ConditionsAcute Myocardial Infarction (AMI)ST-Segment Elevation Myocardial Infarction(STEMI)Non-ST-Segment Elevation Myocardial Infarction(NSTEMI)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorHarbin Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female patients aged ≥18 years and ≤75 years;

Diagnosis of type 1 AMI, including STEMI (onset <24 hours or 7-14 days) or NSTEMI;

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);

Reference diameter of the culprit lesion >2.5 mm and ≤4.0 mm;

Disqualifiers

Severe cardiac dysfunction (Killip/NYHA class ≥ 3) or LVEF < 30%;

Cardiopulmonary resuscitation (CPR) performed at the onset of AMI;

Persistent hemodynamic or cardiac electrical instability after TIMI flow restoration;

Contraindication to antithrombotic drugs, or concurrent hemorrhagic diseases such as peptic ulcer or coagulation disorders;

Trial design

Design model

Parallel

Treatments tested in this trial

Guideline-recommended standard medical therapy alone
Drug
Dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction
DES implantation plus guideline-recommended standard medical therapy
Procedure/Surgery
DES implantation plus dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction.

Treatment groups

2,000 Participants

are divided into 2 treatment groups

Group A: Guideline-recommended standard medical therapy aloneExperimental treatment 1 intervention

Group B: DES implantation plus guideline-recommended standard medical therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame