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)
Qiang Liu,
Shiqiang Li,
Jinlong Zhang,
Fan Jiang,
Bin Yang,
Jianan Wang,
Jun Pu,
Jun Jiang,
Hao Zhou,
Peng Chen,
Liang Lu,
Dongsheng Lu,
Bon-Kwon Koo,
Jinyu Huang,
Lijun Guo,
Xinyang Hu,
Eun-Seok Shin,
Shengxian Tu,
Xiaoping Peng,
Yibin Pan,
Wenming He,
Jilin Li,
Zhenfeng Cheng,
Jianliang Ma,
Daqing Song,
Yongzhen Fan,
Zhaohui Meng,
Lijiang Tang
Affiliations
Qiang Liu
Linyi People`s Hospital, Linyi, Shandong, China
Shiqiang Li
Zhejiang Greentown Cardiovascular Hospital, Hangzhou, China
Jinlong Zhang
The Second Affiliated Hospital of Zhejiang University School of Medicine; State Key Laboratory of Transvascular Implantation Devices, Hangzhou, Zhejiang, China
Fan Jiang
The Affiliated Hospital of Hangzhou Normal University, Hangzhou, China
Bin Yang
Second Hospital of Shanxi Medical University, Taiyuan, China
Jianan Wang
The Second Affiliated Hospital of Zhejiang University School of Medicine; State Key Laboratory of Transvascular Implantation Devices, Hangzhou, Zhejiang, China
Jun Pu
Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
Jun Jiang
The Second Affiliated Hospital of Zhejiang University School of Medicine; State Key Laboratory of Transvascular Implantation Devices, Hangzhou, Zhejiang, China
Hao Zhou
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
Peng Chen
The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
Liang Lu
Dongyang People`s Hospital, Jinhua, China
Dongsheng Lu
Changxing People`s Hospital, Huzhou, China
Bon-Kwon Koo
Seoul National University Hospital, Seoul, Korea (the Republic of)
Jinyu Huang
Affiliated Hangzhou First People’s Hospital, Hangzhou, China
Lijun Guo
Peking University Third Hospital, Beijing, China
Xinyang Hu
The Second Affiliated Hospital of Zhejiang University School of Medicine; State Key Laboratory of Transvascular Implantation Devices, Hangzhou, Zhejiang, China
Eun-Seok Shin
Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea (the Republic of)
Shengxian Tu
Biomedical Instrument Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China
Xiaoping Peng
The First Affiliated Hospital of Nanchang University, Nanchang, China
Yibin Pan
Jinhua Central Hospital, Jinhua, China
Wenming He
The Affiliated Hospital of Medical School of Ningbo University, Ningbo, China
Jilin Li
The Second Affiliated Hospital of Shantou University Medical College, Shantou, China
Zhenfeng Cheng
Huzhou Central Hospital, Huzhou, China
Jianliang Ma
The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China
Daqing Song
Jining No.1 People`s Hospital, Jining, China
Yongzhen Fan
Zhongnan Hospital of Wuhan University, Wuhan, China
Zhaohui Meng
First Affiliated Hospital of Kunming Medical University, Kunming, China
Introduction 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.Method and analysis 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.Ethics and dissemination 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.Trial registration number NCT04397211.
