EROSION III: OCT- vs Angio-based Reperfusion Strategy for STEMI

NCT ID: NCT03571269

Last Updated: 2021-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 246 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-21
• Study Completion Date: 2020-12-24

Brief 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.

Conditions

ST-segment Elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OCT-guided group

Detailed methods of OCT examination are the same as above. Whether stenting or not will be decided by the operators according to the underlying mechanisms of culprit lesions. If stenting, OCT will be used to guide and optimize the whole process of PCI. Patients will be treated with dual antiplatelet therapy (aspirin+ticagrelor or aspirin+clopidogrel) for at least 12 months.

Group Type: EXPERIMENTAL

Optical coherence tomography-guided reperfusion strategy

Intervention Type: PROCEDURE

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.

Angiography-guided group

Detailed methods of angiography examination are the same as above. Whether stenting or not and the whole process of PCI will be decided by the operators according to the current treatment standard of angiography. Patients will be treated with dual antiplatelet therapy (aspirin+ticagrelor or aspirin+clopidogrel) for at least 12 months.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Optical coherence tomography-guided reperfusion strategy

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. 18 years old ≤ age ≤ 80 years old;

2. Patients with STEMI<12h;

3. The target lesion is located in a native coronary artery;

4. The residual diameter stenosis (DS) is ≤70% on angiogram and thrombolysis in myocardial infarction (TIMI) flow grade is 3 after thrombus aspiration or not;

5. Written informed consent.

Exclusion Criteria

1. Patients who are breastfeeding or pregnant or planning to pregnant during the study period;

2. Patients with a history of heart failure;

3. Hemodynamic instability;

4. Target lesion such as: left main coronary artery; three-vessel disease; ostial lesion (defined as within 3mm of the left main coronary artery or aorto-ostium); tortuous lesion; angular lesion;

5. Subjects with contraindication of contrast medium;

6. There are contraindications to aspirin or clopidogrel;

7. Severe hepatic and renal insufficiency (ALT or AST >3x upper limits of normal, creatinine>2.0 mg/dL or end-stage renal disease);

8. Patients with bleeding tendency such as peptic ulcer, bleeding or coagulation disorders;

9. AMI is caused by surgery, trauma, gastrointestinal bleeding, PCI, or its complications;

10. AMI occurs in patients who have been hospitalized for other reasons;

11. Patients who were considered with poor compliance and could not complete the study as required judged by the investigators;

12. Patient with life expectancy ≤24 months;

13. Patients with heart transplantation;

14. Patients with definite diagnosis of tumors;

15. Patients who are currently enrolled in other clinical trial (except other subjects in this project) which has not reached its primary endpoint;

16. Patients who are not suitable for the current study judged by the investigators.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Hospital of Jilin University

OTHER

Sponsor Role: collaborator

Daqing Oil Field Hospital

OTHER

Sponsor Role: collaborator

Tianjin Chest Hospital

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Nanchang University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Xinjiang Medical University

OTHER

Sponsor Role: collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Guangxi Medical University

OTHER

Sponsor Role: collaborator

Peking University First Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

The Second Hospital of Hebei Medical University

OTHER

Sponsor Role: collaborator

The Second Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role: collaborator

Harbin Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yu Bo

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bo Yu

Role: STUDY_CHAIR

The Second Affiliated Hospital of Harbin Medical University

Bin Liu

Role: PRINCIPAL_INVESTIGATOR

Second Hospital of Jilin University

Jianping Li

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Yanqing Wu

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Nanchang University

Ling Li

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Zhengzhou University

Chunmei Wang

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital

Yin Liu

Role: PRINCIPAL_INVESTIGATOR

Tianjin Chest Hospital

Dajun Yuan

Role: PRINCIPAL_INVESTIGATOR

The Second Affilated Hospital of Dalian Medical University

Zhiqi Sun

Role: PRINCIPAL_INVESTIGATOR

Daqing Oil Field Hospital

Yining Yang

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Xinjiang Medical University

Xinshun Gu

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Hebei Medical University

Lang Li

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Guangxi Medical University

Locations

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Peking University First Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Daqing Oil Field Hospital

Daqing, Heilongjiang, China

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The Second Hospital of Jilin University

Jilin, Jilin, China

The Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, China

First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Countries

China

References

Jia H, Dai J, He L, Xu Y, Shi Y, Zhao L, Sun Z, Liu Y, Weng Z, Feng X, Zhang D, Chen T, Zhang X, Li L, Xu Y, Wu Y, Yang Y, Wang C, Li L, Li J, Hou J, Liu B, Mintz GS, Yu B. EROSION III: A Multicenter RCT of OCT-Guided Reperfusion in STEMI With Early Infarct Artery Patency. JACC Cardiovasc Interv. 2022 Apr 25;15(8):846-856. doi: 10.1016/j.jcin.2022.01.298. Epub 2022 Mar 30.

Reference Type: DERIVED

PMID: 35367176 (View on PubMed)

Other Identifiers

2016YFC1301103

Identifier Type: -

Identifier Source: org_study_id