Comparison of Quantitative Flow Ratio (QFR) and Conventional Pressure-wire Based Functional Evaluation for Guiding Coronary Intervention. A Randomized Clinical Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,001
- 试验地点
- 70
- 主要终点
- Patient oriented composite endpoint (PoCE)
研究概览
简要总结
Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. QFR is estimated based on two angiographic projections. Studies have shown a good correlation with the present wire-based standard approach Fractional Flow Reserve (FFR) for assessment of intermediate coronary stenosis. The purpose of the FAVOR III Europe Japan study is to investigate if a QFR-based diagnostic strategy will results in non-inferior clinical outcome after 12 months compared to a standard pressure-wire guided strategy in evaluation of patients with chest pain (stable angina pectoris) and intermediate coronary stenosis.
详细描述
Patients at high risk of having one or more coronary stenosis are evaluated routinely by invasive coronary angiography (CAG). Lesions are often quantified by visual assessment of the angiogram, but physiological assessment of the functional significance by fractional flow reserve has been shown to improve clinical outcome, to reduce number of stents implanted, and has obtained the highest recommendation in European guidelines. FFR is assessed during CAG by advancing a wire with a pressure transducer towards the stenosis and measure the ratio in pressure between the two sides of the stenosis during medical induced maximum blood flow (hyperaemia).
The solid evidence for FFR evaluation of coronary stenosis and the relative simplicity in performing the measurements have supported adoption of an FFR based strategy but the need for interrogating the stenosis by a pressure wire, the small risks associated hereto, the cost of the wire, and the drug inducing hyperaemia has limited more widespread adoption.
Quantitative Flow Ratio is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure drop in the vessel based on computation of two angiographic projections.
Two multi-center studies, the FAVOR II Europe-Japan and China studies evaluated the feasibility and diagnostic performance of in-procedure QFR, showing very good agreement between QFR and FFR.
The purpose of the FAVOR III Europe Japan study is to investigate if a QFR-based diagnostic strategy yields non-inferior 12-month clinical outcome compared to a standard pressure-wire guided strategy in evaluation of patients with stable angina pectoris and intermediate coronary stenosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 years and above
- •Both genders
- •Indication for invasive coronary angiography
- •Patients with stable angina pectoris, or assessment of secondary lesions in stabilized non-STEMI patients or assessment of secondary lesions in patients with prior STEMI and staged evaluation of secondary lesions.
- •Able to provide written informed consent
- •Angiographic inclusion criteria
- •Diameter stenosis of 40-90% diameter stenosis
- •Vessel diameter of at least 2.5 mm and supplying viable myocardium
- •Patients with restenosis in a native coronary artery can be included
排除标准
- •Severely impaired renal function: Glomerular filtration rate (GFR) < 20 mL/min/1.73m²
- •Life expectancy less than one year
- •Cardiogenic shock or unstable haemodynamic state (Killip class III and IV)
- •ST-elevation myocardial infarction (STEMI) within 24 hours
- •Bypass graft to any target vessel
- •Atrial fibrillation at the time of the procedure
- •Chronic total occlusions of any vessel with possible or established indication for treatment
- •Pregnancy or intention to become pregnant during the course of the trial
- •Breast feeding
- •Planned need for concomitant valvular or aortic surgery
- •Left ventricular ejection fraction (LVEF) < 30%
- •Previous inclusion in the FAVOR III trial
- •Enrolled in another clinical study, and for this reason not treated according to present European Society of Cardiology guidelines, or the protocol treatment conflicts with the protocol treatment of FAVOR III
- •Inability to tolerate contrast media
- •Inability to tolerate Adenosine
- •Angiographic exclusion criteria
- •Ostial right coronary artery > 50% diameter stenosis
- •Left main coronary artery > 50% diameter stenosis
- •Lesions properties indicative of myocardial bridging
- •Bifurcation lesions with major (>1 mm) step down in reference size across the bifurcation
- •Severe tortuosity of any target vessel
- •Severe overlap in the stenosed segment
- •Poor image quality precluding identification of vessel contours
结局指标
主要结局
Patient oriented composite endpoint (PoCE)
时间窗: 12 months
A composite endpoint of 1) all-cause mortality, 2) any myocardial infarction, and 3) any unplanned revascularization
次要结局
- Cardiac death(24 months)
- Myocardial infarction(24 months)
- Contrast volume(1 hour)
- Procedure time(1 hour)
- Target vessel failure(24 months)
- Target vessel myocardial infarction(24 months)
- Ischemia driven target vessel revascularization(24 months)
- Number of lesion interrogated(1 hour)
- Fluoroscopy time(1 hour)
- All-cause mortality(24 months)
- Ischemia driven treated target lesion revascularization(24 months)
- Ischemia driven, measured segment revascularization(24 months)
- Feasibility of FFR(1 hour)
- Any unplanned revascularization(24 months)
- Any ischemia driven de novo revascularization(24 months)
- Ischemia driven measured segment de novo revascularization(24 months)
- Feasibility of QFR(1 hour)
- Number of stents implanted(1 hour)
研究者
Evald Hoej Christiansen
Consultant cardiologist, Associate professor
Aarhus University Hospital Skejby