FATE-MAIN: Fractional Flow Reserve Versus Angiography for Treatment-Decision and Evaluation of Significant Left MAIN Coronary Artery Disease
Study Details
Study Description
Brief Summary
The primary objective of the FATE-MAIN trial is to demonstrate that Fractional Flow Reserve(FFR)-guided Percutaneous Coronary Intervention(PCI) is superior to angiography-guided PCI in patients with significant Left Main Coronary Artery disease(LMCA) (defined as ≥50% diameter stenosis) who are eligible for PCI with respect to the primary composite outcome of death, Myocardial Infarction(MI), hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest, or repeat revascularization at 1 year.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: FFR-guided Left Main PCI
|
Procedure: FFR-Guided PCI
Fractional Flow Reserve-Guided PCI
|
| Active Comparator: Angiography-Guided PCI
|
Procedure: Angiography-Guided PCI
Angiography-Guided PCI
|
Outcome Measures
Primary Outcome Measures
- The composite event rate [12 months]
Composite event consists of death from any causes, MI, or hospitalization for unstable angina, heart failure, resuscitated cardiac arrest, or repeat revascularization. A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed.
Secondary Outcome Measures
- The event rate of death from any causes [12 months]
- The event rate of myocardial infarction [12 months]
any, spontaneous or procedural myocardial infarction
- The event rate of hospitalization for unstable angina, heart failure, resuscitated cardiac arrest, or repeat revascularization. [12 months]
- The event rate of death from cardiovascular causes [12 months]
- The event rate of death from noncardiovascular causes [12 months]
- The composite event rate of death or myocardial infarction [12 months]
- The event rate of stent thrombosis [12 months]
Stent thrombosis by Academic Research Consortium (ARC) definition
- The event rate of stroke [12 months]
- The event rate of bleeding complications [12 months]
Bleeding Academic Research Consortium [BARC] type 3-5, which indicates severe bleeding
- Procedure time [1 day]
- Amount of contrast agent used [1 day]
- Length of hospital stay [an average of 7 day]
- The event rate of rehospitalization [12 months]
Rehospitalization from any, cardiac, or noncardiac causes
- Functional class [7 days and 1, 6, 12 months]
Functional class assessed by the Canadian Cardiovascular Society (CCS) Angina Score classification. The minimum and maximum values are I and IV respectively and a higher score means a worse outcome.
- Change of angina-related quality of life index [7 days and 1, 6, 12 months]
By the Seattle Angina Questionnaire [SAQ]. the SAQ is a disease-specific patient-reported outcome (PRO) with 5 domains. Lower score represents poor health status and high score represents good health status.
- Change of health-related quality of life index [7 days and 1, 6, 12 months]
By the EQ-5D. EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group. Range 0 - 1 and a higher score of EQ-5D mean low quality of life.
- Number of anti-anginal medications [7 days and 1, 6, 12 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
The subject must be ≥20 years of age with angina and/or evidence of myocardial ischemia.
-
Significant de novo LMCA disease, defined as ≥ 50% diameter stenosis by visual estimation with or without concomitant non-left main major epicardial coronary artery disease, amenable to PCI with drug-eluting stent(DES) implantation.
-
The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Exclusion Criteria:
-
Extremely calcified or tortuous vessels precluding FFR measurement.
-
The presence of complex coronary disease anatomy or lesion characteristics or other cardiac condition(s) which leads the participating interventional cardiologist to believe that PCI is not suitable (i.e. the subject should be managed with CABG or medical therapy alone).
-
Recent ST Elevation Myocardial Infarction(<7 days prior to randomization).
-
Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support.
-
Severe left ventricular dysfunction (ejection fraction <30%).
-
Requirement for other cardiac surgical procedure (e.g., valve replacement or aorta surgery).
-
Contraindication or inability to take aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, or clopidogrel).
-
Prior PCI of the left main trunk.
-
Prior coronary artery bypass graft surgery.
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Subjects requiring or who may require additional surgery (cardiac or noncardiac) within 1 year.
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End-stage renal disease requiring renal replacement therapy.
-
Liver cirrhosis.
-
Pregnant and/or lactating women.
-
Concurrent medical condition with a limited life expectancy of less than 2 years.
-
Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Asan Medical Center | Seoul | Songpa-gu | Korea, Republic of | 138-736 |
Sponsors and Collaborators
- Seung-Jung Park
- CardioVascular Research Foundation, Korea
Investigators
- Principal Investigator: Duk-woo Park, MD, Asan Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AMCCV2023-02