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Angiography-derived fractional flow reserve versus intravascular ultrasound to guide percutaneous coronary intervention in patients with coronary artery disease (FLAVOUR II): a multicentre, randomised, non-inferiority trial

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收录情况： ◇ SCIE ◇ 自然指数

作者：
Hu Xinyang[1] * ; Zhang Jinlong[1] * ; Yang Seokhun[2] * ; Jiang Jun[1] ; Peng Xiaoping[3] ; Lu Dongsheng[4] ; Pan Yibin[5] ; Guo Lijun[6] ; Li Jilin[7] ; He Wenming[8] ; Zhou Hao[9] ; Pu Jun[10] ; Huang Jinyu[11] ; Jiang Fan[12] ; Liu Qiang[13] ; Song Daqing[14] ; Lu Liang[15] ; Cheng Zhenfeng[16] ; Yang Bin[17] ; Ma Jianliang[18] ; Chen Peng[19] ; Li Shiqiang[20] ; Meng Zhaohui[21] ; Tang Lijiang[22] ; Fan Yongzhen[23] ; Shin Eun-Seok[24] ; Tu Shengxian[25] ; Nam Chang-Wook[26] ; Fearon William F[27] ; Koo Bon-Kwon[28] ; Wang Jian'an[29] ;
机构： [1]Department of Cardiology, the Second Affiliated Hospital of Zhejiang University School of Medicine, State Key Laboratory of Transvascular Implantation Devices, Heart Regeneration and Repair Key Laboratory of Zhejiang Province, Transvascular Implantation Devices Research Institute, Hangzhou, China. [2]Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea. [3]Department of Cardiology, the First Affiliated Hospital of Nanchang University, Jiangxi Hypertension Research Institute, Nanchang, China. [4]Department of Cardiology, Changxing People's Hospital, Huzhou, China. [5]Department of Cardiology, Jinhua Central Hospital, Jinhua, China. [6]Department of Cardiology, Peking University Third Hospital, Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Ministry of Health, Beijing, China. [7]Department of Cardiology, the Second Affiliated Hospital of Shantou University Medical College, Shantou, China. [8]Department of Cardiology, the First Affiliated Hospital of Ningbo University, Ningbo, China. [9]Department of Cardiology, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China. [10]Department of Cardiology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China. [11]Department of Cardiology, Hangzhou First People's Hospital, Hangzhou, China. [12]Department of Cardiology, the Affiliated Hospital of Hangzhou Normal University, Hangzhou, China. [13]Department of Cardiology, the Fourth People's Hospital of Jinan, Jinan, China. [14]Department of Cardiology, Jining No.1 People's Hospital, Jining, China. [15]Department of Cardiology, Dongyang People's Hospital, Jinhua, China. [16]Department of Cardiology, Huzhou Central Hospital, Huzhou, China. [17]Department of Cardiology, Second Hospital of Shanxi Medical University, Taiyuan, China. [18]Department of Cardiology, the Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China. [19]Department of Cardiology, the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, China. [20]Department of Cardiology, Zhejiang Greentown Cardiovascular Hospital, Hangzhou, China. [21]Department of Cardiology, First Affiliated Hospital of Kunming Medical University, Kunming, China. [22]Department of Cardiology, Zhejiang Hospital, Hangzhou, China. [23]Department of Cardiology, Zhongnan Hospital of Wuhan University, Wuhan, China. [24]Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea. [25]Biomedical Instrument Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China. [26]Department of Cardiology, Keimyung University Dongsan Medical Center, Daegu, South Korea. [27]Division of Cardiovascular Medicine and Stanford Cardiovascular Institute, Stanford University School of Medicine, Stanford, CA, USA, VA Palo Alto Health Care System, Palo Alto, CA, USA. [28]Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea. [29]Department of Cardiology, the Second Affiliated Hospital of Zhejiang University School of Medicine, State Key Laboratory of Transvascular Implantation Devices, Heart Regeneration and Repair Key Laboratory of Zhejiang Province, Transvascular Implantation Devices Research Institute, Hangzhou, China.
出处：
DOI： 10.1016/S0140-6736(25)00504-5
ISSN：

摘要：
Revascularisation decisions based on angiography-derived fractional flow reserve (FFR) or optimisation of stent implantation with intravascular ultrasound yield superior clinical outcomes compared with percutaneous coronary intervention (PCI) guided by angiography alone. However, the differences in outcomes when a single approach is used for both purposes remain unclear. We aimed to assess the non-inferiority of angiography-derived FFR versus intravascular ultrasound guidance in terms of clinical outcomes at 12 months in patients with angiographically significant stenosis.This investigator-initiated, open-label, multicentre, randomised, non-inferiority trial, which was done in 22 centres in China, enrolled patients aged 18 years or older with suspected ischaemic heart disease and with at least 50% stenosis in epicardial coronary arteries measuring at least 2·5 mm by visual estimation on coronary angiography. Patients were randomly assigned (1:1) to undergo PCI guided by either angiography-derived FFR or intravascular ultrasound, including revascularisation decisions and optimisation of the stent implantations based on prespecified PCI criteria and optimal PCI goals. Use of both modalities simultaneously was not permitted. Randomisation as performed using a web-based program and stratified based on the trial centre and the presence or absence of diabetes. The primary outcome was a composite of death, myocardial infarction, or revascularisation at 12 months in the intention-to-treat population, and the non-inferiority margin was 2·5 percentage points. This trial is registered with ClinicalTrials.gov, NCT04397211; long-term follow-up is ongoing.Between May 29, 2020, and Sept 20, 2023, 1872 patients were enrolled. After 33 patients withdrew, 923 patients were randomly assigned to the angiography-derived FFR group and 916 to the intravascular ultrasound group. Median age of the study population was 66·0 years (IQR 58·0-72·0), and 1248 (67·9%) patients were male and 591 (32·1%) were female. Revascularisation was performed in 688 (69·5%) of 990 target vessels in the angiography-derived FFR group and 797 (81·0%) of 984 target vessels in the intravascular ultrasound group. At a median follow-up of 12 months (IQR 12-12), the primary outcome event occurred in 56 patients in the angiography-derived FFR group and 54 patients in the intravascular ultrasound group (6·3% vs 6·0%, absolute difference 0·2 percentage points [upper boundary of one-sided 97·5% CI 2·4], pnon-inferiority=0·022; hazard ratio 1·04 [95% CI 0·71 to 1·51]). Mortality did not differ between the two groups (1·8% in the angiography-derived FFR group vs 1·3% in the intravascular ultrasound group, absolute difference 0·4 percentage points [95% CI -0·7 to 1·6]; hazard ratio 1·34 [0·63 to 2·83], p=0·45). The incidence of recurrent angina was low in both groups: 26 (2·8%) of 923 patients in the angiography-derived FFR group and 35 (3·8%) of 916 patients in the intravascular ultrasound group.The angiography-derived FFR-guided comprehensive PCI strategy, encompassing revascularisation decision making and stent optimisation, was non-inferior to intravascular ultrasound guidance. This finding might have implications for future guidelines on its role and application.National Natural Science Foundation of China, The Key R & D Projects of Zhejiang Province, and the RCT Program from The Second Affiliated Hospital of Zhejiang University School of Medicine.Copyright © 2025 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.

基金：
The study was funded in part by National Natural Science Foundation of China (82225004), by the Key R & D Projects of Zhejiang Province (2023C03086), and by the RCT Program from the Second Affiliated Hospital of Zhejiang University School of Medicine.
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出版当年[2026]版：
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大类 | 1 区 医学
小类 | 1 区 医学：内科
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无
最新[2024]版：
Q1 MEDICINE, GENERAL & INTERNAL

影响因子： 最新[2024版] 最新五年平均 出版当年[2025版] 出版当年五年平均 出版前一年[2024版]

第一作者：
第一作者机构： [1]Department of Cardiology, the Second Affiliated Hospital of Zhejiang University School of Medicine, State Key Laboratory of Transvascular Implantation Devices, Heart Regeneration and Repair Key Laboratory of Zhejiang Province, Transvascular Implantation Devices Research Institute, Hangzhou, China.
共同第一作者：
通讯作者：
推荐引用方式(GB/T 7714)：
Hu Xinyang,Zhang Jinlong,Yang Seokhun,et al.Angiography-derived fractional flow reserve versus intravascular ultrasound to guide percutaneous coronary intervention in patients with coronary artery disease (FLAVOUR II): a multicentre, randomised, non-inferiority trial[J].Lancet (London, England).2025,405(10488):1491-1504.doi:10.1016/S0140-6736(25)00504-5.
APA：
Hu Xinyang,Zhang Jinlong,Yang Seokhun,Jiang Jun,Peng Xiaoping...&Wang Jian'an.(2025).Angiography-derived fractional flow reserve versus intravascular ultrasound to guide percutaneous coronary intervention in patients with coronary artery disease (FLAVOUR II): a multicentre, randomised, non-inferiority trial.Lancet (London, England),405,(10488)
MLA：
Hu Xinyang,et al."Angiography-derived fractional flow reserve versus intravascular ultrasound to guide percutaneous coronary intervention in patients with coronary artery disease (FLAVOUR II): a multicentre, randomised, non-inferiority trial".Lancet (London, England) 405..10488(2025):1491-1504

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