Comparison of Clinical Outcomes Between Imaging and Physiology-guided Intervention Strategy in Patients with Intermediate Stenosis: Fractional FLow Reserve and IVUS for Clinical OUtcomes in Patients with InteRmediate Stenosis (FLAVOUR)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,700
- 试验地点
- 5
- 主要终点
- Patient-oriented composite outcome
研究概览
简要总结
To compare the safety and efficacy of FFR (fractional flow reserve)-guided percutaneous coronary intervention (PCI) strategy with IVUS (intravascular ultrasound [IVUS])-guided PCI in patients with intermediate coronary stenosis.
详细描述
- Study overview This study is a prospective, open-label, randomized, multicenter trial to test the safety and efficacy of physiology- or imaging-guided PCI in patients with intermediate coronary stenosis.
The primary hypothesis is that FFR-guided strategy will show non-inferior rate of patients-oriented composite outcomes (POCO) at 24 months after randomization, compared with IVUS-guided strategy in patients with intermediate coronary stenosis. 2. Study population and sample size calculation
Sample Size Calculation Based on the event rates of previous trials, investigators predicted the rates of POCO at 24 months after PCI will be 10% in the FFR-guided arm, and 12% in the IVUS-guided arm.
- Primary endpoint: patient-oriented composite outcome (a composite of all-cause death, MI, any repeat revascularization) at 24 months after PCI
- Design: non-inferiority , delta = 2.5%
- Sampling ratio: FFR-guided strategy : IVUS-guided strategy = 1:1
- Type I error (α): One-sided 5%
- Accrual time : 2 years
- Total time : 4 years (accrual 2 year + follow-up 2 years)
- Assumption: POCO 10.0% vs. 12.0% in FFR or IVUS-guided strategy, respectively
- Statistical power (1- β): 90%
- Primary statistical method : Kaplan-Meier survival analysis with log-rank test
- Potential withdrawal rates : total 2%
- Stratification in Randomization: Presence of Diabetes Mellitus (600 patients (35%) will be Diabetic patients, with 300 patients in each group)
Based on the above assumption, 1,700 patients (850 patients in each group) will be enrolled in this study with consideration of withdrawal rates. 3. Research Materials and Indication for Revascularization For the FFR-guided strategy arm, a pressure-sensor wire system will be used and the criterion for revascularization is FFR ≤ 0.80. Hyperemia will be induced by intravenous infusion of adenosine (140ug/kg/min). For the IVUS-guided strategy arm, the criterion for revascularization is MLA ≤ 3mm2 or [3mm2 < MLA ≤ 4mm2 and plaque burden > 70%]. 4. Funding This is an investigator-initiated study with grant support from Boston Scientific. Other than financial sponsorship, the company has no role in protocol development or the implementation, management, data collection, and analysis of this study. 5. Extended Outcome Follow-Up Following the 2-year follow-up period, clinical outcomes will also be collected until September 30, 2024, to assess the long-term outcomes of each treatment group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria
- •Subject must be ≥ 19 years ② Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic or imaging evaluation and PCI and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
- •Patients suspected with ischemic heart disease ④ Patients with intermediate degree of stenosis (40-70% stenosis by visual estimation) eligible for stent implantation who need FFR or IVUS for further evaluation ⑤ Target vessel size > 2.5mm
- •Target lesions located at the proximal to mid part of coronary artery
排除标准
- •Known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Adenosine.
- •Active pathologic bleeding
- •Gastrointestinal or genitourinary major bleeding within the prior 3 months.
- •History of bleeding diathesis, known coagulopathy (including heparin-induced thrombocytopenia) ⑤ Non-cardiac co-morbid conditions with life expectancy < 2 years ⑥ Target lesion located in coronary arterial bypass graft ⑦ Target lesion located in the left main coronary artery
研究组 & 干预措施
FFR-guided stenting
Percutaneous coronaryintervention using drug-eluting stent(s) will be performed by FFR-guided strategy.
干预措施: FFR-guided stenting (Procedure)
IVUS-guided stenting
Percutaneous coronaryintervention using drug-eluting stent(s) will be performed by IVUS-guided strategy.
干预措施: IVUS-guided stenting (Procedure)
结局指标
主要结局
Patient-oriented composite outcome
时间窗: 24 months
a composite of all death, myocardial infarction (MI) or any revascularization
Long-term patient-oriented composite outcome
时间窗: Up to 7 years
A composite of all death, myocardial infarction \[MI, including peri-procedural MI\] or any revascularization during the extended follow-up period after randomization according to the ARC consensus.
次要结局
- Long-term patient-oriented composite outcome in the medical treatment group(Up to 7 years)
- Long-term target vessel failure according to QFR values(Up to 7 years)
- Long-term target vessel failure(Up to 7 years)
- Any revascularization(24 months)
- Angina severity measured with Seattle Angina Questionnaires(24 months)
- Long-term patient-oriented composite outcome in subgroups by lipid profiles(Up to 7 years)
- Long-term target vessel myocardial infarction(Up to 7 years)
- Long-term target vessel revascularization(Up to 7 years)
- Long-term target lesion revascularization(Up to 7 years)
- Long-term non-target lesion revascularization-target vessel revascularization(Up to 7 years)
- Long-term patient-oriented composite outcome in the PCI group(Up to 7 years)
- Landmark analysis for target vessel failure(Up to 7 years)
- Long-term target vessel failure according to PCI optimization(Up to 7 years)
- Long-term target vessel failure in the medical treatment group(Up to 7 years)
- Long-term target vessel failure according to IVUS-derived plaque characteristics(Up to 7 years)
- Patient-oriented composite outcome(12 months)
- Target-vessel and all-cause nonfatal myocardial infarction with per-procedural myocardial infarction(24 months)
- Cost-effectiveness analysis(24 months)
- Target-vessel and all-cause nonfatal myocardial infarction without per-procedural myocardial infarction(24 months)
- Non-target vessel/lesion revascularization(24 months)
- Stent-oriented composite endpoint(24 months)
- All-cause death(24 months)
- Peri-procedural MI using referred definitions(At discharge (1 week after index procedure))
- Long-term myocardial infarction(Up to 7 years)
- Long-term any revascularization(Up to 7 years)
- Long-term stent thrombosis(Up to 7 years)
- Long-term patient-oriented composite outcome according to PCI optimization(Up to 7 years)
- Long-term target vessel failure in the PCI group(Up to 7 years)
- Cardiac death(24 months)
- Stroke(24 months)
- Long-term patient-oriented composite outcome in subgroups by use of anti-platelet agent and lipid-lowering agents(Up to 7 years)
- Landmark analysis for patient-oriented composite outcome(Up to 7 years)
- Target vessel/lesion revascularization(24 months)
- Academic Research Consortium defined - Stent thrombosis(24 months)
- Long-term mortality(Up to 7 years)
- Long-term stroke(Up to 7 years)
- Acute success of procedure(immediately after the intervention)
- Stent-oriented composite endpoint(12 months)
- Angina severity measured with Seattle Angina Questionnaires(12 months)
研究者
Bon-Kwon Koo
Professor
Seoul National University Hospital