Prognostic Impact of Lesion-specific Hemodynamic Index in Patients With Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
The investigators aim to investigate the additive prognostic value of lesion-specific hemodynamic index such as ΔFFR, non-hyperemic pressure ratio such as RFR, over % diameter stenosis and FFR according to treatment strategy, and to find the prognostic implications of post-PCI FFR after adjustment of various clinical and disease characteristics, and to construct a comprehensive risk prediction model for post-PCI outcomes.

Detailed Description
-----------------
Fractional flow reserve (FFR)-based revascularization is the currently best practice recommended by guidelines. In addition to the use of coronary physiological indices as a vessel-specific metric, recent studies suggested the clinical importance of local hemodynamics in prediction of risk for target vessel failure or acute coronary syndrome in patients with coronary artery disease. In patients who receive percutaneous coronary intervention (PCI), the absolute value and pattern of FFR change after stenting are helpful in defining the additional target for PCI and risk stratification after PCI. However, there has been no prospective study that proved the benefit of change in FFR across the lesion (ΔFFR) in daily clinical practice, and FFR usage after stenting is much less than before stenting. Accordingly, we will prove the benefit of ΔFFR in addition to FFR, prognostic implications of combining RFR and FFR, and the comprehensive risk model with post-PCI FFR, clinical and disease characteristics in a prospective study, to maximize the benefit of invasive physiologic assessment.

Official Title
-----------------
Prognostic Impact of Lesion-specific Hemodynamic Index and Disease Characteristics in Patients With Coronary Artery Disease Assessed by Fractional Flow Reserve

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Fractional flow reserve


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥20 years All comers who underwent successful FFR measurement and pullback tracing Exclusion Criteria: Chronic renal failure (estimated glomerular filtration rate <30) ST-elevation myocardial infarction within 72 hours or previous coronary artery bypass graft surgery history Primary myocardial or valvular disease Left ventricular ejection fraction < 30% Hemodynamically unstable clinical conditions Life expectancy < 2 years

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Deferral of PCI group<br>Patients who undergo successful FFR pullback tracing and have a vessel determined to defer revascularization after FFR measurement will be included. | Diagnostic Test: Fractional flow reserve<br>* Physiologic assessment includes Δ FFR (lesion-specific) and FFR (vessel-specific) measurement. Δ FFR is defined as a pressure step up across the lesion. Coronary angiography and physiologic assessment will be analyzed by an independent core laboratory (Seoul National University Hospital, Clinical Trial Center, Seoul, South Korea).<br>|
| PCI group<br>Patients who undergo successful FFR pullback tracing and have a vessel that undergo stent implantation and FFR measurement both before and after revascularization (pre-PCI FFR and post-PCI FFR) will be included. | Diagnostic Test: Fractional flow reserve<br>* Physiologic assessment includes Δ FFR (lesion-specific) and FFR (vessel-specific) measurement. Δ FFR is defined as a pressure step up across the lesion. Coronary angiography and physiologic assessment will be analyzed by an independent core laboratory (Seoul National University Hospital, Clinical Trial Center, Seoul, South Korea).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse cardiovascular event according to ΔFFR (Deferral of PCI group) | Composite of 2-year target vessel revascularization, target vessel myocardial infarction, and cardiac death | Upto 2 years after index procedure | 
| Adverse cardiovascular event according to post-PCI FFR (PCI group) | Composite of 2-year target vessel revascularization, target vessel myocardial infarction, and cardiac death | Upto 2 years after index procedure |