Coronary Artery Disease
Conditions
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.
Interventions
DIAGNOSTIC_TESTFractional flow reserve
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).
Sponsors
Keimyung University Dongsan Medical Center
Inje University
Ulsan University Hospital
Dong-A University Hospital
Gyeongsang National University Hospital
KangWon National University Hospital
Wonju Severance Christian Hospital
Severance Hospital
Seoul National University Bundang Hospital
Tsuchiura Kyodo General Hospital
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥20 years 2. All comers who underwent successful FFR measurement and pullback tracing
Exclusion criteria
1. Chronic renal failure (estimated glomerular filtration rate \<30) 2. ST-elevation myocardial infarction within 72 hours or previous coronary artery bypass graft surgery history 3. Primary myocardial or valvular disease 4. Left ventricular ejection fraction \< 30% 5. Hemodynamically unstable clinical conditions 6. Life expectancy \< 2 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse cardiovascular event according to ΔFFR (Deferral of PCI group) | Upto 2 years after index procedure | Composite of 2-year target vessel revascularization, target vessel myocardial infarction, and cardiac death |
| Adverse cardiovascular event according to post-PCI FFR (PCI group) | Upto 2 years after index procedure | Composite of 2-year target vessel revascularization, target vessel myocardial infarction, and cardiac death |
Countries
South Korea
Contacts
Primary ContactBon-Kwon Koo, MD, PhD
Backup ContactSeokhun Yang, MD
Outcome results
None listed