INsTantenous wavE-Free Ratio-guided PCI Versus Fractional Flow REserve-Guided PCI in rouTine Clinical Practice, Prospective, Multicenter Registry

Study Overview
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Brief Summary
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The current study sought to evaluate the clinical relevance of iFR-guided strategy in real world clinical practice using unrestricted study population from stable angina to acute coronary syndrome including acute ST-segment elevation myocardial infarction. Previous abundant historical data of FFR-guided strategy will be also included as historical control to validate the iFR-guided strategy.

Detailed Description
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In this study, the investigators will validate the clinical relevance of instantaneous wave free ratio (iFR)-guided strategy in real world clinical practice in Korea. The 1,200 patients who underwent iFR measurement will be prospectively enrolled at 5 centers in Republic of Korea. In patients who were indicated revascularization after iFR measurement (iFR<0.90), iFR pullback system (iFR Scout) and post-revascularization iFR measurement will be routinely performed. The primary hypothesis will be tested for non-inferiority of iFR-guided strategy, compared with FFR-guided strategy in terms of 2-year clinical outcomes. For the clinical outcome data following FFR-guided strategy will be used from the pooled data of the DEFER-DES trial, the 3V FFR FRIENDS registry (NCT01621438), and Korean 4-center FFR registry. Using those data, 1200 patients will be selected from the pooled data. In addition, routine application of iFR Scout and post-revascularization iFR measurement will enable us to validate the clinical relevance of iFR-based prediction of acute procedural results and to compare FFR-pullback methods. Primary Hypothesis: The iFR-guided strategy will be non-inferior regarding patient-oriented composite outcomes (a composite of any death, any MI, any revascularization) at 2-year, compared with FFR-guided strategy. Primary Outcome: 1] Patient-oriented composite outcome (POCO), defined as a composite of any death, any myocardial infarction (MI) or any revascularization at 2-year after index procedure according to the ARC consensus [2] Difference between Predicted post-PCI iFR value from iFR Scout and Actual post-PCI iFR measurement Sample Size 1,200 patients with suspected ischemic heart disease including stable angina, or acute coronary syndrome including unstable angina, non ST-segment elevation MI, or ST-segment elevation MI with non-culprit stenosis enrolled at 5 centers in Republic of Korea. Inclusion Criteria ① Subject must be ≥18 years ② Patients suspected with ischemic heart disease ③ Patients with coronary artery stenosis with intermediate degree of stenosis (40-70% stenosis by visual estimation) in major epicardial coronary artery amenable to stent implantation or vessel size≥2.5 mm without definitive previous evidence of myocardial ischemia. ④ Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and he/she or his/her legally authorized representative provides Exclusion criteria Cardiogenic shock (systolic blood pressure < 90mmHg or requiring inotropics to maintain blood pressure > 90mmHg) ② Patients with a known hypersensitivity or contraindication to any of the following medications: statin, ezetimibe, heparin, aspirin, clopidogrel, prasugrel, ticagrelor Non-cardiac co-morbid conditions are present with life expectancy <2 year (per site investigator's medical judgment). History of bleeding diathesis, known coagulopathy (including heparin-induced thrombocytopenia) ⑤ Patients with active pathologic bleeding ⑥ Gastrointestinal or genitourinary major bleeding within the prior 3 months. ⑦ Target lesion located in coronary arterial bypass graft

Official Title
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Multicenter Registry for Instantaneous Wave-Free Ratio (iFR)-Guided Percutaneous Coronary Intervention in Routine Clinical Practice

Conditions
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Stable Angina, Non ST Segment Elevation Myocardial Infarction, ST-segment Elevation Myocardial Infarction, Silent Myocardial Ischemia, Unstable Angina

Intervention / Treatment
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* Other: Instantaneous wave-free ratio measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be ≥18 years Patients suspected with ischemic heart disease ③ Patients with coronary artery stenosis with intermediate degree of stenosis (40-70% stenosis by visual estimation) in major epicardial coronary artery amenable to stent implantation or vessel size≥2.5 mm without definitive previous evidence of myocardial ischemia. Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and he/she or his/her legally authorized representative provides Exclusion Criteria: Cardiogenic shock (systolic blood pressure < 90mmHg or requiring inotropics to maintain blood pressure > 90mmHg) Patients with a known hypersensitivity or contraindication to any of the following medications: statin, ezetimibe, heparin, aspirin, clopidogrel, prasugrel, ticagrelor ③ Non-cardiac co-morbid conditions are present with life expectancy <2 year (per site investigator's medical judgment). History of bleeding diathesis, known coagulopathy (including heparin-induced thrombocytopenia) Patients with active pathologic bleeding ⑥ Gastrointestinal or genitourinary major bleeding within the prior 3 months. ⑦ Target lesion located in coronary arterial bypass graft

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| iFR-guied strategy group<br>1,200 patients with suspected ischemic heart disease including stable angina, or acute coronary syndrome including unstable angina, non ST-segment elevation MI, or ST-segment elevation MI with non-culprit stenosis who underwent iFR measurement and enrolled at 5 centers in Republic of Korea. | Other: Instantaneous wave-free ratio measurement<br>* Instantaneous wave-free ratio measurement in order to evaluate functional significance of epicardial stenosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-oriented composite outcome (POCO) | a composite of any death, any myocardial infarction (MI) or any revascularization according to the ARC consensus | at 2-year after index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between Predicted post-PCI iFR value from iFR Scout and Actual post-PCI iFR measurement | Difference between Predicted post-PCI iFR value from iFR Scout and Actual post-PCI iFR measurement | Immediate after post revascularization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fractional flow reserve, Instantaneous wave-free ratio, Ischemic heart disease