Prognostic Impact of Lesion-specific Hemodynamic Index and Disease Characteristics in Patients With Coronary Artery Disease Assessed by Fractional Flow Reserve
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,429
- 试验地点
- 1
- 主要终点
- Adverse cardiovascular event according to ΔFFR (Deferral of PCI group)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥20 years
- •All comers who underwent successful FFR measurement and pullback tracing
排除标准
- •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
结局指标
主要结局
Adverse cardiovascular event according to ΔFFR (Deferral of PCI group)
时间窗: 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)
时间窗: Upto 2 years after index procedure
Composite of 2-year target vessel revascularization, target vessel myocardial infarction, and cardiac death
次要结局
未报告次要终点
研究者
Bon-Kwon Koo
Professor
Seoul National University Hospital
