Impact of Coronary CT Angiography, Physiologic Assessment and Pharmacotherapy on the Clinical Outcomes

Seoul National University Hospital992 enrolled

Overview

The investigators aim to investigate the prognostic implication of stenosis and plaque features on coronary CT angiography (CCTA), physiologic assessment, and pharmacotherapy after invasive coronary angiography.

Stenosis severity, plaque features, and myocardial ischemia have been known as important indicators in diagnosis and prognostication of patients with coronary artery disease. Invasive physiologic indies such as fractional flow reserve (FFR) are used to define ischemia-causing stenosis in the catheterization laboratory. FFR represents maximal blood flow to the myocardium supplied by an artery with stenosis as a fraction of normal maximum flow. The FFR-guided strategy was reported to improve the patients' outcomes in comparison with the angiography-guided strategy. However, clinical events still occur in patients with FFR \>0.80, and invasive therapy did not improve prognosis in patients with moderate to severe ischemia compared to optimal medical therapy in the ISCHEMIA trial. In the recent report, the prognosis in the vessel with FFR \>0.80 was associated with high-risk plaque characteristics on coronary CT angiography (CCTA). Likewise, incorporation of stenosis and plaque features and myocardial ischemia may provide better risk stratification of patients with coronary artery disease than evaluating each attribute alone. Recent proposed novel measurement such as pericoronary inflammation or epicardial fat metrics and lesion-specific or vessel-specific hemodynamic parameters derived from CCTA has also been known as a robust prognostic predictor. In addition, antiplatelet agents and lipid-lowering medication such as aspirin, clopidogrel, or statin are commonly used for primary and secondary prevention of adverse cardiovascular events. However, the relationship of combination and dosage of those drugs with prevention of plaque progression and clinical outcomes has not been fully understood. Accordingly, the investigators aim to find the prognostic implications of stenosis and plaque features, fat metrics on CCTA along with physiologic assessment and pharmocotherapy according to the different treatment strategies.

Study Type

OBSERVATIONAL

Enrollment

992

Conditions

Coronary Artery Disease

Interventions

Fractional flow reserve, Coronary CT angiographyDIAGNOSTIC_TEST

1. Coronary CT angiography (CCTA) and measurement of fractional flow reserve (FFR) will be performed as part of routine clinical practice. The decision to perform CCTA before invasive angiography was at the judgment of the physicians in charge. 2. Physiologic assessment includes delta FFR (lesion-specific) and FFR (vessel-specific) measurement. Delta 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). 3. Stenosis and plaque features on CCTA will be analyzed by an independent CCTA core laboratory (Severance Cardiovascular Hospital, Seoul, Korea), and pericoronary and epicardial fat metrics (fat attenuation index, epicardial fat attenuation index, epicardial fat volume, etc.) will be obtained by an independent cardiac CT fat core laboratory (Tsuchiura Kyodo general hospital, Ibaraki, Japan).

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

1\) Deferral of PCI group Inclusion Criteria: 1. Age ≥ 20 years 2. Patients who undergo CCTA within 90 days before FFR measurement by clinical needs 3. Patients with a vessel determined to defer revascularization after FFR measurement. Exclusion Criteria: 1. Left ventricular ejection fraction \< 35% 2. Acute ST-elevation myocardial infarction within 72 hours or previous coronary artery bypass graft surgery 3. Abnormal epicardial coronary flow (TIMI flow \< 3) 4. Failed FFR measurement 5. Planned coronary artery bypass graft surgery after diagnostic angiography 6. Poor quality of CCTA which is unsuitable for plaque analysis 7. Patients with a stent in the target vessel 2\) PCI group Inclusion Criteria: 1. Age ≥ 20 years 2. Patients who undergo CCTA within 90 days before FFR measurement by clinical needs 3. Patients with a vessel that undergo stent implantation and FFR measurement both before and after revascularization (pre-PCI FFR and post-PCI FFR). * Patients with multiple vessels that meet inclusion criteria of the deferral of PCI group and PCI group will be assigned to the PCI group. Exclusion Criteria: 1. Left ventricular ejection fraction \< 35% 2. Acute ST-elevation myocardial infarction within 72 hours or previous coronary artery bypass graft surgery 3. Abnormal epicardial coronary flow (TIMI flow \< 3) 4. Failed FFR measurement 5. Planned coronary artery bypass graft surgery after diagnostic angiography 6. Poor quality of CCTA which is unsuitable for plaque analysis 7. Patients with a stent in the target vessel

Locations (1)

Seoul National University Hospital

Seoul, Select, South Korea

RECRUITING

Outcomes

Primary Outcomes

Adverse cardiovascular event according to stenosis and plaque features (Deferral group).

A composite of cardiac death, vessel-related myocardial infarction (MI), or vessel-related ischemia-driven revascularization. The target vessel will be defined as the vessel with FFR measurement.