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| Name | Class |
|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
| Samsung Medical Center | OTHER |
| Ulsan University Hospital | OTHER |
| Keimyung University Dongsan Medical Center |
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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.
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.
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.
Based on the above assumption, 1,700 patients (850 patients in each group) will be enrolled in this study with consideration of withdrawal rates.
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%].
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FFR-guided stenting | Active Comparator | Percutaneous coronaryintervention using drug-eluting stent(s) will be performed by FFR-guided strategy. |
|
| IVUS-guided stenting | Active Comparator | Percutaneous coronaryintervention using drug-eluting stent(s) will be performed by IVUS-guided strategy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FFR-guided stenting | Procedure | The percutaneous coronaryintervention using drug-eluting stent will be indicated according to following criteria in the FFR-guided strategy arm * Criteria for revascularization: The FFR ≤ 0.80 will be targeted for PCI |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-oriented composite outcome | a composite of all death, myocardial infarction (MI) or any revascularization | 24 months |
| Long-term patient-oriented composite outcome | 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. | Up to 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-oriented composite outcome | a composite of all death, myocardial infarction (MI) or any | 12 months |
| Stent-oriented composite endpoint | a composite of cardiac death, target-vessel MI, or target lesion revascularization |
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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
Exclusion Criteria
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.
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| Name | Affiliation | Role |
|---|---|---|
| Bon-Kwon Koo, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Seung-Jea Tahk, MD, PhD | Ajou University School of Medicine | Principal Investigator |
| JianAn Wang, MD, PhD | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital, School of Medicine, Zhejiang University | Zhejiang | China | ||||
| Keimyung University Dongsan Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39886193 | Derived | Ding D, Zhang J, Wu P, Wang Z, Shi H, Yu W, Hu X, Kang J, Hahn JY, Nam CW, Doh JH, Lee BK, Kim W, Huang J, Jiang F, Zhou H, Chen P, Tang L, Jiang W, Chen X, He W, Ahn SG, Yoon MH, Kim U, Ki YJ, Shin ES, Tahk SJ, Pu J, Wijns W, Wang J, Koo BK, Tu S. Prognostic Value of Postpercutaneous Coronary Intervention Murray-Law-Based Quantitative Flow Ratio: Post Hoc Analysis From FLAVOUR Trial. JACC Asia. 2025 Jan 7;5(1):59-70. doi: 10.1016/j.jacasi.2024.10.019. eCollection 2025 Jan. | |
| 39601394 |
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The deidentified data will be shared after publication of first manuscript
Data will be available within 12 months of study completion.
Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| OTHER |
| Inje University | OTHER |
| KangWon National University Hospital | OTHER |
| Ajou University School of Medicine | OTHER |
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| IVUS-guided stenting | Procedure | The percutaneous coronaryintervention using drug-eluting stent will be indicated according to following criteria in the IVUS-guided strategy arm * Criteria for revascularization: Minimum lumen area (MLA) ≤ 3mm2 or (MLA ≤ 4mm2 AND Plaque burden >70%) |
|
| 12 months |
| Stent-oriented composite endpoint | a composite of cardiac death, target-vessel MI, or target lesion revascularization | 24 months |
| Cost-effectiveness analysis | medical expenses of treatment and follow-up. Cost estimates utilize micro-costing, the total cost by identifying the utilization of medical resources used, and macro-costing, medical expenses resulting from clinical events from health insurance data. | 24 months |
| All-cause death | death from any cause | 24 months |
| Cardiac death | death from cardiaccause | 24 months |
| Target-vessel and all-cause nonfatal myocardial infarction without per-procedural myocardial infarction | Myocardial infarction during 24 months follow-up without periprocedural myocardial infarction | 24 months |
| Target-vessel and all-cause nonfatal myocardial infarction with per-procedural myocardial infarction | Myocardial infarction during 24 months follow-up with periprocedural myocardial infarction | 24 months |
| Peri-procedural MI using referred definitions | Number of participants with peri-procedural myocardial infarction after PCI | At discharge (1 week after index procedure) |
| Target vessel/lesion revascularization | Number of participants and vessels/lesions with ischemia-driven or any reavascularizations at target vessel/lesion | 24 months |
| Non-target vessel/lesion revascularization | Number of participants and vessels/lesions with ischemia-driven or any reavascularizations at non-target vessel/lesion. | 24 months |
| Any revascularization | Number of participants and vessels/lesions with ischemia-driven or any revascularizations at any vessel/lesion | 24 months |
| Academic Research Consortium defined - Stent thrombosis | Number of participants with definite/probable/possible stent thrombosis | 24 months |
| Stroke | Number of participants with ischemic or hemorrhagic stroke | 24 months |
| Acute success of procedure | Device-related, lesion-related and procedure-related success of index procedure (residual diameter stenosis<50% and thrombolysis in myocardial infarction flow 3) | immediately after the intervention |
| Angina severity measured with Seattle Angina Questionnaires | Seattle Angina Questionnaires (physical limitation and angina frequency were classified as minimal: 75-100, mild: 50-74, moderate: 25-49, severe: 0-24) | 12 months |
| Angina severity measured with Seattle Angina Questionnaires | Seattle Angina Questionnaires (physical limitation and angina frequency were classified as minimal: 75-100, mild: 50-74, moderate: 25-49, severe: 0-24) | 24 months |
| Long-term patient-oriented composite outcome in subgroups by use of anti-platelet agent and lipid-lowering agents | A composite of all death, myocardial infarction [MI, including peri-procedural MI] or any revascularization during the extended follow-up period in subgroups stratified by use of anti-platelet agent and lipid-lowering agents | Up to 7 years |
| Long-term patient-oriented composite outcome in subgroups by lipid profiles | Long-term patient-oriented composite outcome in subgroups stratified by changes in LDL-cholesterol, HDL-cholesterol, and triglyceride during the extended follow-up period | Up to 7 years |
| Long-term mortality | All-cause and cardiac death during the extended follow-up period | Up to 7 years |
| Long-term myocardial infarction | Myocardial infarction during the extended follow-up period | Up to 7 years |
| Long-term any revascularization | Any revascularization during the extended follow-up period | Up to 7 years |
| Long-term target vessel failure | Target vessel failure (cardiac death, target vessel MI, target vessel revascularization) during the extended follow-up period | Up to 7 years |
| Long-term target vessel myocardial infarction | Target vessel myocardial infarction during the extended follow-up period | Up to 7 years |
| Long-term target vessel revascularization | Target vessel revascularization during the extended follow-up period | Up to 7 years |
| Long-term target lesion revascularization | Target lesion revascularization during the extended follow-up period | Up to 7 years |
| Long-term non-target lesion revascularization-target vessel revascularization | Non-target lesion revascularization-target vessel revascularization during the extended follow-up period | Up to 7 years |
| Long-term stent thrombosis | Stent thrombosis (definite/probable/possible) during the extended follow-up period | Up to 7 years |
| Long-term stroke | Stroke (ischemic and hemorrhagic) during the extended follow-up period | Up to 7 years |
| Landmark analysis for patient-oriented composite outcome | A 2 year landmark analysis of patient-oriented composite outcome and its individual outcome components | Up to 7 years |
| Long-term patient-oriented composite outcome in the medical treatment group | Patient-oriented composite outcome and individual components of outcomes in the medical treatment group | Up to 7 years |
| Long-term patient-oriented composite outcome in the PCI group | Patient-oriented composite outcome and individual components of outcomes in the PCI group | Up to 7 years |
| Long-term patient-oriented composite outcome according to PCI optimization | Patient-oriented composite outcome and individual outcome components among patients in the PCI group, comparing those who received PCI optimization to those who did not. | Up to 7 years |
| Landmark analysis for target vessel failure | A 2 year landmark analysis of target vessel failure and its individual outcome components | Up to 7 years |
| Long-term target vessel failure in the medical treatment group | Target vessel failure and individual components of outcomes in the medical treatment group | Up to 7 years |
| Long-term target vessel failure in the PCI group | Target vessel failure and individual components of outcomes in the PCI group | Up to 7 years |
| Long-term target vessel failure according to PCI optimization | Target vessel failure and individual outcome components among patients in the PCI group, comparing those who received PCI optimization to those who did not. | Up to 7 years |
| Long-term target vessel failure according to IVUS-derived plaque characteristics | Target vessel failure (cardiac death, target vessel MI, target vessel revascularization) during the extended follow-up period according to IVUS-derived plaque characteristics | Up to 7 years |
| Long-term target vessel failure according to QFR values | Target vessel failure (cardiac death, target vessel MI, target vessel revascularization) during the extended follow-up period according to QFR values | Up to 7 years |
| Daegu |
| South Korea |
| Inje University Ilsan Paik Hospital | Goyang | South Korea |
| Samsung Medical Center, Sungkyunkwan University School of Medicine | Seoul | 135-710 | South Korea |
| Seoul National University Hospital, Seoul, Korea | Seoul | South Korea |
| Derived |
| Hwang D, Kim HL, Ko J, Choi H, Jeong H, Jang SA, Hu X, Kang J, Zhang J, Jiang J, Hahn JY, Nam CW, Doh JH, Lee BK, Kim W, Huang J, Jiang F, Zhou H, Chen P, Tang L, Jiang W, Chen X, He W, Ahn SG, Kim U, Ki YJ, Shin ES, Kim HS, Tahk SJ, Wang J, Lee TJ, Koo BK; FLAVOUR Investigators. Cost-effectiveness of Fractional Flow Reserve Versus Intravascular Ultrasound to Guide Percutaneous Coronary Intervention: Results From the FLAVOUR Study. Korean Circ J. 2025 Jan;55(1):34-46. doi: 10.4070/kcj.2024.0156. Epub 2024 Oct 11. |
| 38956940 | Derived | Lee JH, Ahn SG, Jeon HS, Lee JW, Youn YJ, Zhang J, Hu X, Wang J, Lee JM, Hahn JY, Nam CW, Doh JH, Lee BK, Kim W, Huang J, Jiang F, Zhou H, Chen P, Tang L, Jiang W, Chen X, He W, Yoon MH, Tahk SJ, Kim U, Ki YJ, Shin ES, Hwang D, Kang J, Kim HS, Koo BK. Discordance Between Angiographic Assessment and Fractional Flow Reserve or Intravascular Ultrasound in Intermediate Coronary Lesions: A Post-hoc Analysis of the FLAVOUR Trial. Korean Circ J. 2024 Aug;54(8):485-496. doi: 10.4070/kcj.2024.0046. Epub 2024 Jun 10. |
| 38018840 | Derived | Lee JM, Kim H, Hong D, Hwang D, Zhang J, Hu X, Jiang J, Nam CW, Doh JH, Lee BK, Kim W, Huang J, Jiang F, Zhou H, Chen P, Tang L, Jiang W, Chen X, He W, Kang J, Ahn SG, Yoon MH, Kim U, Ki YJ, Shin ES, Choi KH, Park TK, Yang JH, Song YB, Choi SH, Gwon HC, Koo BK, Kim HS, Tahk SJ, Wang J, Hahn JY; FLAVOUR Investigators. Clinical Outcomes of Deferred Lesions by IVUS Versus FFR-Guided Treatment Decision. Circ Cardiovasc Interv. 2023 Dec;16(12):e013308. doi: 10.1161/CIRCINTERVENTIONS.123.013308. Epub 2023 Nov 29. |
| 36053504 | Derived | Koo BK, Hu X, Kang J, Zhang J, Jiang J, Hahn JY, Nam CW, Doh JH, Lee BK, Kim W, Huang J, Jiang F, Zhou H, Chen P, Tang L, Jiang W, Chen X, He W, Ahn SG, Yoon MH, Kim U, Lee JM, Hwang D, Ki YJ, Shin ES, Kim HS, Tahk SJ, Wang J; FLAVOUR Investigators. Fractional Flow Reserve or Intravascular Ultrasonography to Guide PCI. N Engl J Med. 2022 Sep 1;387(9):779-789. doi: 10.1056/NEJMoa2201546. |
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |