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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Coronary Artery Disease Left Main
• Intervention / Treatment: Procedure: FFR-Guided PCI; Procedure: Angiography-Guided PCI

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 934
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Duk-woo Park, MD; Email: dwpark@amc.seoul.kr

Study Locations

• Korea, Republic of
  • Songpa-gu
    • Seoul, Songpa-gu, Korea, Republic of, 138-736
      • Recruiting
      • Asan Medical Center
      • Contact: Seung-jung Park, MD, PhD
      • Principal Investigator: Seung-jung Park, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The subject must be ≥20 years of age with angina and/or evidence of myocardial ischemia.
2. 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.
3. 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:

1. Extremely calcified or tortuous vessels precluding FFR measurement.
2. 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).
3. Recent ST Elevation Myocardial Infarction(<7 days prior to randomization).
4. Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support.
5. Severe left ventricular dysfunction (ejection fraction <30%).
6. Requirement for other cardiac surgical procedure (e.g., valve replacement or aorta surgery).
7. Contraindication or inability to take aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, or clopidogrel).
8. Prior PCI of the left main trunk.
9. Prior coronary artery bypass graft surgery.
10. Subjects requiring or who may require additional surgery (cardiac or noncardiac) within 1 year.
11. End-stage renal disease requiring renal replacement therapy.
12. Liver cirrhosis.
13. Pregnant and/or lactating women.
14. Concurrent medical condition with a limited life expectancy of less than 2 years.
15. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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 stroke		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 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 bleeding complications	Bleeding Academic Research Consortium [BARC] type 3-5, which indicates severe bleeding	2 years
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

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea
• Investigators: Principal Investigator: Duk-woo Park, MD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): April 25, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 30, 2023
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Fractional Flow Reserve
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: AMCCV2023-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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