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Rationale and design of a comparison of angiography-derived fractional flow reserve-guided and intravascular ultrasound-guided intervention strategy for clinical outcomes in patients with coronary artery disease: a randomised controlled trial (FLAVOUR II)

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机构： [1]The Second Affiliated Hospital of Zhejiang University School of Medicine,State Key Laboratory of Transvascular Implantation Devices, Hangzhou, Zhejiang, China [2]Changxing People's Hospital, Huzhou, China [3]Peking University Third Hospital, Beijing, China [4]The First Affiliated Hospital of Nanchang University, Nanchang, China [5]Jinhua Central Hospital, Jinhua, China [6]The Affiliated Hospital of Medical School of Ningbo University, Ningbo, China [7]The Second Affiliated Hospital of Shantou University Medical College, Shantou, China [8]The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China [9]Affiliated Hangzhou First People’s Hospital, Hangzhou, China [10]The Affiliated Hospital of Hangzhou Normal University, Hangzhou, China [11]Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China [12]Huzhou Central Hospital, Huzhou, China [13]Second Hospital of Shanxi Medical University, Taiyuan, China [14]The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China [15]The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, China [16]The Fourth People's Hospital of Jinan, Jinan, China [17]Jining No.1 People's Hospital, Jining, China [18]Dongyang People's Hospital, Jinhua, China [19]Zhejiang Greentown Cardiovascular Hospital, Hangzhou, China [20]Zhongnan Hospital of Wuhan University, Wuhan, China [21]First Affiliated Hospital of Kunming Medical University, Kunming, China [22]Zhejiang Hospital, Hangzhou, China [23]Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea (the Republic of) [24]Biomedical Instrument Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China [25]Seoul National University Hospital, Seoul, Korea (the Republic of)

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Percutaneous coronary intervention (PCI) guided by coronary angiography-derived fractional flow reserve (FFR) or intravascular ultrasound (IVUS) has shown improved clinical outcomes compared with angiography-only-guided PCI. In patients with intermediate stenoses, FFR resulted in fewer coronary interventions and was non-inferior to IVUS with respect to clinical outcomes. However, whether this finding can be applied to angiography-derived FFR in significant coronary artery disease (CAD) remains unclear.The comparison of angiography-derived FFR-guided and IVUS-guided intervention strategies for clinical outcomes in patients with coronary artery disease (FLAVOUR II) trial is a multicentre, prospective, randomised controlled trial. A total of 1872 patients with angiographically significant CAD (stenoses of at least 50% as estimated visually through angiography) in a major epicardial coronary artery will be randomised 1:1 to receive either angiography-derived FFR-guided or IVUS-guided PCI. Patients will be treated with second-generation drug-eluting stent according to the predefined criteria for revascularisation: angiography-derived FFR≤0.8 and minimal lumen area (MLA)≤3 mm2 or 3 mm2<MLA≤4 mm2 and plaque burden>70%. The primary endpoint is a composite of all-cause death, myocardial infarction and revascularisation at 12 months after randomisation. We will test the non-inferiority of the angiography-derived FFR-guided strategy compared with the IVUS-guided decision for PCI and the stent optimisation strategy.The FLAVOUR II trial will provide new insights into optimal evaluation and treatment strategies for patients with CAD.FLAVOUR II was approved by the institutional review board at each participating site (The Second Affiliated Hospital of Zhejiang University School of Medicine Approval No: 2020LSYD410) and will be conducted in line with the Declaration of Helsinki. Informed consent would be obtained from each patient before their participation. The study results will be submitted to a scientific journal.NCT04397211.© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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大类 | 3 区医学

小类 | 3 区医学：内科

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Q1 MEDICINE, GENERAL & INTERNAL

最新[2023]版：

Q1 MEDICINE, GENERAL & INTERNAL

影响因子： 2.4 最新[2023版] 2.7 最新五年平均 2.4 出版当年[2023版] 2.7 出版当年五年平均 2.9 出版前一年[2022版]

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第一作者机构： [1]The Second Affiliated Hospital of Zhejiang University School of Medicine,State Key Laboratory of Transvascular Implantation Devices, Hangzhou, Zhejiang, China

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