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

ST-segment Elevation Myocardial Infarction Clinical Trial

Official title:

Effective ReperfusiOn Strategy for Patients With ST-segment Elevation Myocardial Infarction Guided by Optical Coherence Tomography Versus ANgiography (EROSION III): a Multicenter, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03571269
• Other study ID #: 2016YFC1301103
• Status: Completed
• Phase: N/A
• Start date: December 21, 2017
• Est. completion date: December 24, 2020

Study information

• Verified date: August 2021
• Source: Harbin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: December 24, 2020
• Est. primary completion date: January 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• ST-segment Elevation Myocardial Infarction

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Dalian Medical University	Dalian	Liaoning
China	Daqing Oil Field Hospital	Daqing	Heilongjiang
China	The 2nd Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Second Hospital of Jilin University	Jilin	Jilin
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	Beijing Anzhen Hospital	Peking	Beijing
China	Peking University First Hospital	Peking	Beijing
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Tianjin Chest Hospital	Tianjin	Tianjin
China	First Affiliated Hospital of Xinjiang Medical University	Ürümqi	Xinjiang
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (12)

Lead Sponsor

Collaborator

Harbin Medical University

Beijing Anzhen Hospital, Daqing Oil Field Hospital, First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital of Xinjiang Medical University, Peking University First Hospital, Second Affiliated Hospital of Nanchang University, Second Hospital of Jilin University, The First Affiliated Hospital of Zhengzhou University, The Second Affiliated Hospital of Dalian Medical University, The Second Hospital of Hebei Medical University, Tianjin Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary effective endpoint of OCT-guided reperfusion strategy (powered)	Patient-level rate of stent implantation between the two groups	Immediate after primary PCI
Primary	Primary safety endpoint of OCT-guided reperfusion strategy	The incidence of recurrent myocardial ischemic events (unstable angina-induced rehospitalization, recurrent myocardial infarction, target lesion revascularization) or cardiac death.	Within 1 month
Secondary	Incidence of cardiocerebrovascular events	Cardiocerebrovascular events include cardiac death, recurrent myocardial infarction, stroke, target lesion revascularization, malignant arrhythmia, and unstable angina-induced rehospitalization.	Within 1 year
Secondary	Incidence of heart failure event	Heart failure is a complex syndrome in which ventricular filling or ejection fraction is impaired due to structural or functional abnormality of the heart.	Within 1 year