EROSION II: OCT Guided PPCI in STEMI

A Prospective, Multi-center, Optical Coherence Tomography Guided Reperfusion Strategy in Patients With STEMI (EROSION II)

This protocol describes a prospective, multi-center study intended to test the hypothesis that patients with STEMI caused by plaque rupture or plaque erosion without obstructive stenosis (diameter stenosis <70%) can be stabilized by effective antithrombotic treatment without stent implantation, thereby avoiding both early and late complications related to percutaneous coronary intervention (PCI) with stent implantation. All the patients will be followed by intracoronary OCT and physiological assessment at 1-month and 12-month follow-up.

Study Overview

• Status: Active, not recruiting
• Conditions: ST-segment Elevation Myocardial Infarction
• Intervention / Treatment: Drug: dual antiplatelet therapy (aspirin + ticagrelor or aspirin + clopidogrel)

Detailed Description

EROSION (Effective anti-thrombotic therapy without stenting: intravascular optical coherence tomography-based management in plaque erosion) study, a single-center, uncontrolled, prospective, proof-of concept study, showed that for patients with ACS caused by non-obstructive plaque erosion, conservative treatment with anti-thrombotic therapy without stenting may be an option. However, it is unknown whether plaque rupture with large lumen area and non-obstructive stenosis can be treated medically without stenting. EROSION II study is a prospective, multi-center, observational study to test the hypothesis that patients with STEMI caused by plaque rupture or plaque erosion without obstructive stenosis (diameter stenosis <70% by visual assessment) can be stabilized and healed by effective antithrombotic treatment without stent implantation. Patients presenting with STEMI within 24 hours from the onset of ischemic symptoms will be included for screening. Thrombus aspiration will be performed in patients with large thrombus burden and TIMI flow grade less than 2 to restore blood flow. OCT will be performed after antegrade blood flow restored to assess the underlying mechanism of culprit lesion including plaque rupture, plaque erosion, calcified nodule, spontaneous coronary artery dissection, and other uncommon reasons. OCT imaging of non-culprit vessels will be performed if feasible. Patients caused by plaque erosion or plaque rupture with minimal lumen area > 1.6mm2 or non-obstructive stenosis (diameter stenosis <70% by visual assessment) will be treated medically only with dual anti-platelet therapy for 12 months after discharge.

Serial OCT examination will be performed at 1-month and 12-month follow-up to assess the healing of original culprit lesion. Physiological assessment (either wire-based FFR or angio-based FFR) will also be performed to assess the hemodynamic function of culprit lesion. The primary endpoint is the reduction of thrombus burden assessed by OCT at 1-month follow-up. Presence of recurrent ischemia symptoms or positive FFR value are the indications for target lesion revascularization. Patients will be followed by phone calls by study coordinators or clinical visit at 1 month, 3 months, 6 months, 9 months and 12 months. Major cardiovascular adverse events (MACE) will be collected in all patients throughout the whole follow-up period. MACE is a composite of cardiac death, recurrent myocardial infarction, stroke, target lesion revascularization, major bleeding and unstable angina-induced rehospitalization.

Patients who do not meet the criteria after OCT imaging will be enrolled in registry cohort.

Blood sample will be obtained from artery sheath or coronary artery by aspiration catheter during the PCI procedure in selected sites. Blood samples will be stored at -80°C for potential biomarker test and multi-omics analysis.

• Study Type: Observational
• Enrollment (Actual): 347

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 101100
      • Beijing Luhe hospital
  • Fujian
    • Xiamen, Fujian, China
      • Xiamen Cardiovascular Hospital, Xiamen University
  • Gansu
    • Lanzhou, Gansu, China
      • The First Hospital of Lanzhou University
  • Guangzhou
    • Shenzhen, Guangzhou, China
      • Shenzhen Sun Yat-sen Cardiovascular Hospital
  • Hebei
    • Shijiazhuang, Hebei, China
      • Hebei General Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • The Second Affiliated Hospital of Harbin Medical University
  • Hubei
    • Wuhan, Hubei, China
      • Wuhan Asia Heart Hospital
  • Jiangsu
    • Zhenjiang, Jiangsu, China
      • Affiliated Hospital of Jiangsu University
  • Jilin
    • Changchun, Jilin, China, 130000
      • The First Hospital of Jilin University
    • Changchun, Jilin, China, 130000
      • China-Japan Union Hospital of Jilin University
  • Ningxia
    • Yinchuan, Ningxia, China
      • General Hospital of Ningxia Medical University
  • Shanxi
    • Taiyuan, Shanxi, China
      • Second Hospital of Shanxi Medical University
    • Taiyuan, Shanxi, China
      • Shanxi Cardiovascular Hospital
  • Shenyang
    • Dalian, Shenyang, China
      • The First Affiliated Hospital of Dalian Medical University
  • Sichuan
    • Chengdu, Sichuan, China
      • Sichuan Provincial People's Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Sir Run Run Shaw Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study population is STEMI patients who undergo primary cardiac catheterization.

Description

Inclusion Criteria:

• Men or non-pregnant women >18 years of age and < 75 years of age.
• Patients undergo cardiac catheterization for STEMI. STEMI will be defined as continuous chest pain for >30 minutes, arrival at the hospital within 24 hours from chest pain onset, ST-segment elevation >0.1 mV in at least two contiguous leads, or new left bundle-branch block on the 12-lead electrocardiogram (ECG), and elevated cardiac markers (troponin T/I or creatine kinase-MB).
• Culprit lesion located in a native coronary artery.
• TIMI flow grade 3 and diameter stenosis < 70% by visual assessment on angiogram or MLA > 1.6mm2.
• Plaque erosion and rupture defined by OCT.
• Patients able to provide written informed consent.

Exclusion Criteria:

• Left ventricular ejection fraction < 30%.
• Lesions in LM, ostial LAD or RCA (defined as within 3 mm of the aorto-ostium).
• Long lesions, tortuous lesions and angulated lesions.
• More than 2 vessels with severe lesions.
• Massive residual thrombus after the thrombus aspiration.
• With the history of cardiopulmonary resuscitation (CPR), acute pulmonary edema and cardiac shock on the attacks.
• Life expectancy < 1 year.
• Contraindication to the contrast media.
• Creatinine level > 2.0 mg/dL or end-stage kidney disease.
• Serious liver dysfunction.
• Patients with hemodynamic or electrical instability (including shock).
• Any contraindication against the use of ticagrelor.
• Investigator considers the patient is not suitable.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with STEMI treated medically; Drug: dual antiplatelet therapy (aspirin + ticagrelor or aspirin + clopidogrel) for at least 12 months.	Drug: dual antiplatelet therapy (aspirin + ticagrelor or aspirin + clopidogrel); Patients who met the inclusion criteria will be treated with dual antiplatelet therapy (aspirin + ticagrelor or aspirin + clopidogrel).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of thrombus burden assessed by OCT	The efficacy will be assessed by 50% reduction in thrombus burden by OCT at 1 month.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major cardiovascular adverse events	In patients treated conservatively, the safety objectives are to evaluate the occurrence of any adverse events during 1, 3, 6, 9, 12 months follow up (re-infarction, re-hospitalization due to unstable angina, revascularization by PCI or CABG, cardiac death, stroke, and major bleeding).	1, 3, 6, 9, 12 months after PCI
Major cardiovascular adverse events	compare the difference of clinical outcome in patients with plaque rupture and erosion.	1 and 12 months after PCI
Effective flow area increase	Effective flow area increase	1 and 12 months after PCI
Fractional flow reserve	either wire-based FFR or angio-based FFR	1 and 12 months after PCI

Collaborators and Investigators

• Sponsor: Harbin Medical University
• Collaborators: LanZhou University; Hebei General Hospital; The First Hospital of Jilin University; Sir Run Run Shaw Hospital; Wuhan Asia Heart Hospital; General Hospital of Ningxia Medical University; Sichuan Provincial People's Hospital; Affiliated Hospital of Jiangsu University; China-Japan Union Hospital, Jilin University; The First Affiliated Hospital of Dalian Medical University; Second Hospital of Shanxi Medical University; Shanxi Cardiovascular Hospital; Beijing Luhe Hospital; Shenzhen Sun Yat-sen Cardiovascular Hospital; Shenzhen Salubris Pharmaceuticals Co., Ltd.; Xiamen Cardiovascular Hospital, Xiamen University

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2017
• Primary Completion (Actual): February 24, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: February 20, 2017
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Optical Coherence Tomography; ST-segment Elevation Myocardial Infarction
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Aspirin; Ticagrelor; Clopidogrel
• Other Study ID Numbers: HMUOCT-EROSIONII

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: 2020
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

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