EROSION III: OCT- vs Angio-based Reperfusion Strategy for STEMI
Condition: ST-segment Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      Brief Summary: This study is a prospective, multicenter, randomized, controlled trial aimed
      to compare the reperfusion strategy and clinical outcomes of STEMI patients treated by
      angiography-guided vs. OCT-guided PCI. Patients presenting STEMI with coronary artery
      diameter stenosis ≤70% and TIMI blood flow grade 3 at index or after thrombus aspiration are
      randomly assigned to either an OCT-guided group or an angiography-guided group. In OCT-guided
      group, stent implantation or conservative medical treatment is determined based on OCT
      findings. Conservative non-stenting strategy will be recommended in those with culprit plaque
      erosions, certain ruptures without dissection and hematoma, SCAD without obstructive
      stenosis. In the angiography-guided group, reperfusion strategy is decided by the operators
      according to the local practice. The rate of stenting during primary PCI and clinical
      outcomes at 1-month and 1-year are collected.
    

Detailed description: 
      Methodology: As a multicenter, prospective, randomized, controlled trial, patients with
      ST-segment elevation myocardial infarction (STEMI) who have an intermediate stenotic culprit
      lesion (angiographic diameter stenosis ≤70%) and TIMI flow grade 3 or residual stenosis ≤70%
      after thrombus aspiration and TIMI grade 3 will be enrolled and randomized to OCT-guided
      group or angiography-guided group. In OCT-guided group, pre-PCI OCT imaging of the culprit
      lesion will be performed and revascularization strategy will be determined based on
      underlying mechanism of culprit lesion morphology. For lesions required stenting, OCT
      measurements will be used to guide the selection of stent size and to optimize the result of
      stent implantation. In the angiography-guided group, OCT will not be performed and the PCI
      procedures will be done according to routine practice by the operators. Primary outcome is
      patient-level rate of stenting during primary PCI and the incidence of recurrent myocardial
      ischemic events (unstable angina-induced rehospitalization, recurrent myocardial infarction,
      target lesion revascularization) or cardiac death within 1 month. Secondary outcomes include
      the incidence of cardiocerebrovascular events (cardiac death, recurrent myocardial
      infarction, stroke, target lesion revascularization, malignant arrhythmia, and unstable
      angina-induced rehospitalization) and the incidence of heart failure event within 1 year.

      Patient enrollment and procedure overview: Patients with STEMI<12h in whom coronary
      angiography is planned will be screened. Those have a culprit lesion stenosis ≤70% by visual
      estimation and TIMI blood flow grade 3 at index angiography or after thrombus aspiration will
      be consented to participate in the study. After informed consent obtained, patients will be
      assigned to OCT-guided group or angiography-guided group randomly. In the OCT-guided group,
      OCT imaging of infarcted-related artery will be performed to assess the underlying mechanism
      of culprit lesion. Reperfusion strategy will be decided by the operators according to the OCT
      findings. Conservative medical strategy will be recommended if the underlying mechanism is
      plaque erosions, small ruptures without dissection and hematoma, SCAD without obstructive
      stenosis. Otherwise, stent implantation may be performed. The procedure of stent implantation
      will be guided by OCT according to current guideline and consensus documents. Before stent
      implantation, the landing zone and size of stent will be decided according to the pre-PCI OCT
      images. After implantation, OCT imaging will be performed to optimize the results of stent
      implantation including stent expansion, apposition, edge dissection, tissue protrusion. In
      the angiography-guided group, PCI procedure will be performed according to current guidelines
      and their daily practice. All patients are required to take dual antiplatelet treatment with
      aspirin (100 mg/day) and ticagrelor (180 mg/day) or clopidogrel (75mg/day) for at least 12
      months. The use of low molecular weight heparin and glycoprotein IIb/IIIa inhibitor are
      determined by the operators.

      Follow-up: Patients will be followed by phone calls or clinical visits by study coordinators
      at 1 month (30 days) and 1 year (12 months). Severe adverse events including heart failure
      event, stent failure, cardiac death, recurrent myocardial infarction, stroke, target lesion
      revascularization, malignant arrhythmia, and unstable angina-induced rehospitalization will
      be collected in all patients throughout the whole study period until the last patient
      completes 12 months of follow up. Additional phone follow-up may also be performed subject to
      executive committee approval.
    

Intervention name(s): Optical coherence tomography-guided reperfusion strategy
Intervention type(s): Procedure
Intervention description(s): Optical coherence tomography will be used to detect the detailed characteristics of culprit lesion and to decide and optimize the reperfusion strategy according to the established algorithm in the protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: STEMI; optical coherence tomography; reperfusion