FFR Versus IVUS with Angiography-Derived FFR for Clinical Outcomes in Patients with Coronary Artery Disease
NCT ID: NCT06218485
Last Updated: 2025-02-24
Study Results
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Basic Information
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RECRUITING
NA
1942 participants
INTERVENTIONAL
2024-03-13
2029-12-01
Brief Summary
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Detailed Description
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2. Research materials and indication for revascularization:
2.1 Experimental group: PCI will be performed if angiography-derived FFR ≤0.80 and will be deferred if angiography-derived FFR \>0.80; If PCI is performed, PCI optimization using IVUS will be performed following the recommended criteria: ① Plaque burden at stent edge ≤55%; ② Minimal stent area ≥ 5.5 mm2, or minimal stent area ≥ distal reference lumen area.
2.2 Control group: PCI will be performed if FFR ≤0.80 and will be deferred if FFR \>0.80; If PCI is performed, PCI optimization using FFR will be performed following the recommended criteria: ① Post-PCI FFR ≥ 0.88, or ② Post-PCI ΔFFR (\[FFR at stent distal edge\] - \[FFR at stent proximal edge\]) \< 0.05.
3. Sample size: In the post-hoc analysis of the FLAVOUR I study applying QFR analysis, the 2-year POCO rate was 13.0% in the PCI group with FFR ≤0.80 and undergoing FFR-based PCI optimization and 7.1% in the PCI group with QFR ≤0.80 and undergoing IVUS-based PCI optimization. Meanwhile, the 2-year POCO rate was 5.8% and 6.5% in the deferral of PCI group with FFR \>0.80 and QFR \>0.80, respectively. Assuming a PCI rate of 70% in patients with coronary artery lesions with 50-90% stenosis that is the inclusion criteria for the current study, and considering event rates from historical studies evaluating FFR- and QFR-guided PCI strategies, the cumulative incidence rate of POCO at 24 months was estimated to be 13.0% in the control group (FFR group) and 9.0% in the experimental group (QFR-IVUS group).
* Primary endpoint: POCO, defined as a composite of death from any cause, MI, or any revascularization at 24 months after randomization.
* Design: superiority
* Sampling ratio: experimental group : control group = 1:1
* Type I error (α): One-sided 2.5%
* Accrual time: 24 months
* Total time: 4 years (accrual 24 months + follow-up 24 months)
* Assumption: POCO 13.0% vs. 9.0% in control or experimental group, respectively
* Statistical power (1- β): 90%
* Primary statistical method: Kaplan-Meier survival analysis with log-rank test
* Estimated attrition rate: total 10%
* Stratification in randomization: Presence of diabetes mellitus
Based on the above assumption, we would need total 1,942 patients (971 patients in each group) with consideration of an attrition rate.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental group
The percutaneous coronary intervention will be performed by intravascular ultrasound (IVUS)-guided strategy after angiography-derived FFR-based decision-making.
Intravascular ultrasound-guided stent implantation after angiography-derived FFR-based decision-making
The percutaneous coronary intervention will be performed by intravascular ultrasound (IVUS)-guided strategy after angiography-derived FFR-based decision-making:
1. PCI will be performed if angiography-derived FFR ≤0.80 and will be deferred if angiography-derived FFR \>0.80.
2. If PCI is performed, PCI optimization using IVUS will be performed following the recommended criteria: ① Plaque burden at stent edge ≤55%; ② Minimal stent area ≥ 5.5 mm2, or minimal stent area ≥ distal reference lumen area
Control group
The percutaneous coronary intervention will be performed by fractional flow reserve (FFR)-guided strategy.
Fractional flow reserve-guided PCI strategy
The percutaneous coronary intervention will be performed by fractional flow reserve (FFR)-guided strategy:
1. PCI will be performed if FFR ≤0.80 and will be deferred if FFR \>0.80.
2. If PCI is performed, PCI optimization using FFR will be performed following the recommended criteria: ① Post-PCI FFR ≥ 0.88, or ② Post-PCI ΔFFR (\[FFR at stent distal edge\] - \[FFR at stent proximal edge\]) \< 0.05
Interventions
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Intravascular ultrasound-guided stent implantation after angiography-derived FFR-based decision-making
The percutaneous coronary intervention will be performed by intravascular ultrasound (IVUS)-guided strategy after angiography-derived FFR-based decision-making:
1. PCI will be performed if angiography-derived FFR ≤0.80 and will be deferred if angiography-derived FFR \>0.80.
2. If PCI is performed, PCI optimization using IVUS will be performed following the recommended criteria: ① Plaque burden at stent edge ≤55%; ② Minimal stent area ≥ 5.5 mm2, or minimal stent area ≥ distal reference lumen area
Fractional flow reserve-guided PCI strategy
The percutaneous coronary intervention will be performed by fractional flow reserve (FFR)-guided strategy:
1. PCI will be performed if FFR ≤0.80 and will be deferred if FFR \>0.80.
2. If PCI is performed, PCI optimization using FFR will be performed following the recommended criteria: ① Post-PCI FFR ≥ 0.88, or ② Post-PCI ΔFFR (\[FFR at stent distal edge\] - \[FFR at stent proximal edge\]) \< 0.05
Eligibility Criteria
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Inclusion Criteria
* Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving invasive physiologic or imaging evaluation and PCI with a drug-eluting stent (DES) and he/she or his/her legally authorized representative provides written informed consent.
* Subjects suspected with ischemic heart disease.
* Subjects with coronary artery diameter stenosis 50-90% by angiography-based visual estimation eligible for stent implantation.
* Target vessel size ≥ 2.5mm in visual estimation.
Exclusion Criteria
* Active pathologic bleeding.
* Gastrointestinal or genitourinary major bleeding within the prior 3 months.
* History of bleeding diathesis, known coagulopathy.
* Non-cardiac co-morbid conditions with life expectancy \< 2 years.
* Target lesion located in coronary arterial bypass graft.
* Left main coronary artery stenosis ≥ 50%.
* Chronic total occlusion in the study target vessel.
* Culprit lesion of ST-elevation myocardial infarction (STEMI).
* Not eligible for angiography-derived FFR (ostial RCA ≥ 50% stenosis, severe tortuosity, severe overlap, poor image quality).
19 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Peking University Third Hospital
OTHER
RenJi Hospital
OTHER
Second Affiliated Hospital of Shantou University Medical College
OTHER
The First Affiliated Hospital of Nanchang University
OTHER
First Affiliated Hospital of Kunming Medical University
OTHER
The Fourth People's Hospital of Jinan
UNKNOWN
Jinhua Central Hospital
OTHER
The Affiliated Hospital of Hangzhou Normal University
OTHER
Changxing People's Hospital
OTHER
First Affiliated Hospital of Wenzhou Medical University
OTHER
The Affiliated Hospital of Medical College, Ningbo University
OTHER
Keimyung University Dongsan Medical Center
OTHER
Inje University Ilsan Paik Hospital
OTHER
Ulsan University Hospital
OTHER
Uijeongbu Eulji Medical Center
UNKNOWN
Kyungpook National University Hospital
OTHER
Seoul St. Mary's Hospital
OTHER
Yonsei University Wonju Severance Hospital
UNKNOWN
Inje University Haeundae Paik Hospital
OTHER
Sejong General Hospital
OTHER
Chonnam National University Hospital
OTHER
Ningbo Medical Center Lihuili Hospital
OTHER_GOV
The Affiliated Hospital of Shandong University of TCM
UNKNOWN
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Jian'an Wang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Bon-Kwon Koo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Peking University Third Hospital
Beijing, , China
Second Affiliated Hospital of Shantou University Medical College
Guangdong, , China
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, , China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, , China
Changxing People's Hospital
Huzhou, , China
The Affiliated Hospital of Shandong University of TCM
Jinan, , China
The Fourth People's Hospital of Jinan
Jinan, , China
Jinhua Central Hospital
Jinhua, , China
First Affiliated Hospital of Kunming Medical University
Kunming, , China
The First Affiliated Hospital of Nanchang University
Nanchang, , China
Ningbo Medical Center Lihuili Hospital
Ningbo, , China
The Affiliated Hospital of Medical College, Ningbo University
Ningbo, , China
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, , China
The First Affiliated hospital of Wenzhou Medical University
Wenzhou, , China
Bucheon Sejong Hospital
Bucheon-si, , South Korea
Inje University Haeundae Paik Hospital
Busan, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Chonnam National University Hospital
Donggu, , South Korea
Inje University Ilsan Paik Hospital
Goyang, , South Korea
Seoul National University Hospital,
Seoul, , South Korea
Seoul ST. Mary's Hospital
Seoul, , South Korea
Uijeongbu Eulji Medical Center
Uijeongbu-si, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Yonsei University Wonju Severance Hospital
Wŏnju, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Jilin Li, MD
Role: primary
Xinyang Hu, MD, PhD
Role: primary
Dongsheng Lu, MD
Role: primary
Jianliang Ma, MD
Role: primary
Qiang Liu, MD
Role: primary
Yibin Pan, MD
Role: primary
Xiaoping Peng, MD
Role: primary
Wanying Hu, MD
Role: primary
Wenming He, MD
Role: primary
Hao Zhou
Role: primary
Hyun-Jong Lee, MD, PhD
Role: primary
Dong-Kie Kim, MD, PhD
Role: primary
Chang-Wook Nam, MD, PhD
Role: primary
Jang Hoon Lee, MD, PhD
Role: primary
Young Joon Hong, MD, PhD
Role: primary
Joon-Hyung Doh, MD, PhD
Role: primary
Kwan Yong Lee, MD, PhD
Role: primary
You-Jeong Ki, MD, PhD
Role: primary
Eun-Seok Shin, MD
Role: primary
Sung Gyun Ahn, MD, PhD
Role: primary
References
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Kogame N, Ono M, Kawashima H, Tomaniak M, Hara H, Leipsic J, Andreini D, Collet C, Patel MR, Tu S, Xu B, Bourantas CV, Lerman A, Piek JJ, Davies JE, Escaned J, Wijns W, Onuma Y, Serruys PW. The Impact of Coronary Physiology on Contemporary Clinical Decision Making. JACC Cardiovasc Interv. 2020 Jul 27;13(14):1617-1638. doi: 10.1016/j.jcin.2020.04.040.
Writing Committee Members; Lawton JS, Tamis-Holland JE, Bangalore S, Bates ER, Beckie TM, Bischoff JM, Bittl JA, Cohen MG, DiMaio JM, Don CW, Fremes SE, Gaudino MF, Goldberger ZD, Grant MC, Jaswal JB, Kurlansky PA, Mehran R, Metkus TS Jr, Nnacheta LC, Rao SV, Sellke FW, Sharma G, Yong CM, Zwischenberger BA. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 Jan 18;79(2):e21-e129. doi: 10.1016/j.jacc.2021.09.006. Epub 2021 Dec 9.
Raber L, Mintz GS, Koskinas KC, Johnson TW, Holm NR, Onuma Y, Radu MD, Joner M, Yu B, Jia H, Meneveau N, de la Torre Hernandez JM, Escaned J, Hill J, Prati F, Colombo A, di Mario C, Regar E, Capodanno D, Wijns W, Byrne RA, Guagliumi G; ESC Scientific Document Group. Clinical use of intracoronary imaging. Part 1: guidance and optimization of coronary interventions. An expert consensus document of the European Association of Percutaneous Cardiovascular Interventions. Eur Heart J. 2018 Sep 14;39(35):3281-3300. doi: 10.1093/eurheartj/ehy285.
De Maria GL, Garcia-Garcia HM, Scarsini R, Hideo-Kajita A, Gonzalo Lopez N, Leone AM, Sarno G, Daemen J, Shlofmitz E, Jeremias A, Tebaldi M, Bezerra HG, Tu S, Lemos PA, Ozaki Y, Dan K, Collet C, Banning AP, Barbato E, Johnson NP, Waksman R. Novel Indices of Coronary Physiology: Do We Need Alternatives to Fractional Flow Reserve? Circ Cardiovasc Interv. 2020 Apr;13(4):e008487. doi: 10.1161/CIRCINTERVENTIONS.119.008487. Epub 2020 Apr 16.
Scoccia A, Tomaniak M, Neleman T, Groenland FTW, Plantes ACZD, Daemen J. Angiography-Based Fractional Flow Reserve: State of the Art. Curr Cardiol Rep. 2022 Jun;24(6):667-678. doi: 10.1007/s11886-022-01687-4. Epub 2022 Apr 18.
Collet C, Onuma Y, Sonck J, Asano T, Vandeloo B, Kornowski R, Tu S, Westra J, Holm NR, Xu B, de Winter RJ, Tijssen JG, Miyazaki Y, Katagiri Y, Tenekecioglu E, Modolo R, Chichareon P, Cosyns B, Schoors D, Roosens B, Lochy S, Argacha JF, van Rosendael A, Bax J, Reiber JHC, Escaned J, De Bruyne B, Wijns W, Serruys PW. Diagnostic performance of angiography-derived fractional flow reserve: a systematic review and Bayesian meta-analysis. Eur Heart J. 2018 Sep 14;39(35):3314-3321. doi: 10.1093/eurheartj/ehy445.
Fearon WF, Achenbach S, Engstrom T, Assali A, Shlofmitz R, Jeremias A, Fournier S, Kirtane AJ, Kornowski R, Greenberg G, Jubeh R, Kolansky DM, McAndrew T, Dressler O, Maehara A, Matsumura M, Leon MB, De Bruyne B; FAST-FFR Study Investigators. Accuracy of Fractional Flow Reserve Derived From Coronary Angiography. Circulation. 2019 Jan 22;139(4):477-484. doi: 10.1161/CIRCULATIONAHA.118.037350.
Xu B, Tu S, Qiao S, Qu X, Chen Y, Yang J, Guo L, Sun Z, Li Z, Tian F, Fang W, Chen J, Li W, Guan C, Holm NR, Wijns W, Hu S. Diagnostic Accuracy of Angiography-Based Quantitative Flow Ratio Measurements for Online Assessment of Coronary Stenosis. J Am Coll Cardiol. 2017 Dec 26;70(25):3077-3087. doi: 10.1016/j.jacc.2017.10.035. Epub 2017 Oct 31.
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.
Gotberg M, Christiansen EH, Gudmundsdottir IJ, Sandhall L, Danielewicz M, Jakobsen L, Olsson SE, Ohagen P, Olsson H, Omerovic E, Calais F, Lindroos P, Maeng M, Todt T, Venetsanos D, James SK, Karegren A, Nilsson M, Carlsson J, Hauer D, Jensen J, Karlsson AC, Panayi G, Erlinge D, Frobert O; iFR-SWEDEHEART Investigators. Instantaneous Wave-free Ratio versus Fractional Flow Reserve to Guide PCI. N Engl J Med. 2017 May 11;376(19):1813-1823. doi: 10.1056/NEJMoa1616540. Epub 2017 Mar 18.
Other Identifiers
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2023-0896
Identifier Type: -
Identifier Source: org_study_id
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