Fractional Flow Reserve Versus Angiography for Treatment-Decision and Evaluation of Significant Left MAIN Coronary Artery Disease

Study Overview
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Brief Summary
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The primary purpose of the study was to determine whether the 2-year probability of major adverse cardiac events (primary composite outcome) differed significantly between patients who underwent angiography-guided Percutaneous Coronary Intervention(PCI) and those who underwent Fractional Flow Reserve(FFR)-guided PCI in patients with Left Main Coronary Artery disease(LMCA).

Detailed Description
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All participants will be monitored over a span of two years and the time point of the year of last subject last visit. The term year of last subject last visit refers to the time point of the last visit for all participants. At this specific time point, event occurrence check will be conducted to determine the occurrence of endpoint events among all participants.

Official Title
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A Comparison of Fractional Flow Reserve- Versus Angiography-Guided Percutaneous Coronary Intervention in Patients With Left Main Coronary Artery Disease

Conditions
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Coronary Artery Disease Left Main, Coronary Artery Disease

Intervention / Treatment
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* Procedure: FFR-Guided PCI
* Procedure: Angiography-Guided PCI


Participation Criteria
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Eligibility Criteria
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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 coronary artery bypass graft 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. Subjects requiring or who may require additional surgery (cardiac or noncardiac) within 1 year. 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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FFR-guided Left Main PCI<br> | Procedure: FFR-Guided PCI<br>* Fractional Flow Reserve-Guided PCI<br>|
| Active Comparator: Angiography-Guided PCI<br> | Procedure: Angiography-Guided PCI<br>* Angiography-Guided PCI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The composite event rate | Composite event consists of death from any causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The event rate of death from any causes |  | 2 years | 
| The event rate of myocardial infarction | any, spontaneous or procedural myocardial infarction | 2 years | 
| The event rate of hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest |  | 2 years | 
| The event rate of repeat revascularization |  | 2 years | 
| The composite event rate of death or myocardial infarction |  | 2 years | 
| The event rate of stent thrombosis | Stent thrombosis by Academic Research Consortium (ARC) definition | 2 years | 
| The event rate of stroke |  | 2 years | 
| The event rate of bleeding complications | Bleeding Academic Research Consortium [BARC] type 3-5, which indicates severe bleeding | 2 years | 
| 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 | Rehospitalization from any, cardiac, or noncardiac causes | 2 years | 
| Functional class | 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. | 7 days(discharge) and 1, 6, 12, 24 months | 
| Change of angina-related quality of life index | 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. | 7 days(discharge) and 1, 6, 12, 24 months | 
| Change of health-related quality of life index | 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. | 7 days(discharge) and 1, 6, 12, 24 months | 
| Number of anti-anginal medications |  | 7 days(discharge) and 1, 6, 12, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fractional Flow Reserve, Percutaneous Coronary Intervention