Bo Xu1, Shengxian Tu2, Lei Song3, Zening Jin4, Bo Yu5, Guosheng Fu6, Yujie Zhou7, Jian'an Wang8, Yundai Chen9, Jun Pu10, Lianglong Chen11, Xinkai Qu12, Junqing Yang13, Xuebo Liu14, Lijun Guo15, Chengxing Shen16, Yaojun Zhang17, Qi Zhang18, Hongwei Pan19, Xiaogang Fu20, Jian Liu21, Yanyan Zhao22, Javier Escaned23, Yang Wang22, William F Fearon24, Kefei Dou3, Ajay J Kirtane25, Yongjian Wu3, Patrick W Serruys26, Weixian Yang3, William Wijns27, Changdong Guan3, Martin B Leon25, Shubin Qiao3, Gregg W Stone28. 1. Department of Cardiology, Fuwai Hospital, National Centre for Cardiovascular Diseases, National Clinical Research Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: bxu@citmd.com. 2. Biomedical Instrument Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China. 3. Department of Cardiology, Fuwai Hospital, National Centre for Cardiovascular Diseases, National Clinical Research Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. 4. Department of Cardiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China. 5. Department of Cardiology, the Second Affiliated Hospital of Harbin Medical University, Harbin, China. 6. Department of Cardiology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China. 7. Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China. 8. Department of Cardiology, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. 9. Department of Cardiology, the Sixth Medical Centre, Chinese PLA General Hospital, Beijing, China. 10. Department of Cardiology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China. 11. Department of Cardiology, Fujian Medical University Union Hospital, Fuzhou, China. 12. Department of Cardiology, Huadong Hospital Affiliated to Fudan University, Shanghai, China. 13. Department of Cardiology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China. 14. Department of Cardiology, Tongji Hospital, Tongji University School of Medicine, Shanghai, China. 15. Department of Cardiology, Peking University Third Hospital, Beijing, China. 16. Department of Cardiology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China. 17. Department of Cardiology, Xuzhou Third People's Hospital, Xuzhou Medical University, Xuzhou, China. 18. Department of Cardiology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China. 19. Department of Cardiology, Hunan Provincial People's Hospital, The First Affiliated Hospital of Hunan Normal University, Changsha, China. 20. Shanghai Jiao Tong University-Pulse Medical Imaging Technology Joint Laboratory, Shanghai, China. 21. Department of Cardiology, Peking University People's Hospital, Beijing, China. 22. Medical Research and Biometrics Centre, National Centre for Cardiovascular Diseases, Beijing, China. 23. Hospital Clínico San Carlos IDISSC, Complutense University of Madrid, Madrid, Spain. 24. Division of Cardiovascular Medicine and Stanford Cardiovascular Institute, Stanford University School of Medicine and VA Palo Alto Health Care System, Palo Alto, CA, USA. 25. NewYork-Presbyterian Hospital/Columbia University Medical Centre, New York, NY, USA; The Cardiovascular Research Foundation, New York, NY, USA. 26. Department of Cardiology, National University of Ireland, Galway, Ireland; NHLI, Imperial College London, London, UK. 27. The Lambe Institute for Translational Medicine and Curam, National University of Ireland, Galway, Ireland. 28. The Cardiovascular Research Foundation, New York, NY, USA; The Zena and Michael A Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Abstract
BACKGROUND: Compared with visual angiographic assessment, pressure wire-based physiological measurement more accurately identifies flow-limiting lesions in patients with coronary artery disease. Nonetheless, angiography remains the most widely used method to guide percutaneous coronary intervention (PCI). In FAVOR III China, we aimed to establish whether clinical outcomes might be improved by lesion selection for PCI using the quantitative flow ratio (QFR), a novel angiography-based approach to estimate the fractional flow reserve. METHODS: FAVOR III China is a multicentre, blinded, randomised, sham-controlled trial done at 26 hospitals in China. Patients aged 18 years or older, with stable or unstable angina pectoris or patients who had a myocardial infarction at least 72 h before screening, who had at least one lesion with a diameter stenosis of 50-90% in a coronary artery with a reference vessel of at least 2·5 mm diameter by visual assessment were eligible. Patients were randomly assigned to a QFR-guided strategy (PCI performed only if QFR ≤0·80) or an angiography-guided strategy (PCI based on standard visual angiographic assessment). Participants and clinical assessors were masked to treatment allocation. The primary endpoint was the 1-year rate of major adverse cardiac events, a composite of death from any cause, myocardial infarction, or ischaemia-driven revascularisation. The primary analysis was done in the intention-to-treat population. The trial was registered with ClinicalTrials.gov (NCT03656848). FINDINGS: Between Dec 25, 2018, and Jan 19, 2020, 3847 patients were enrolled. After exclusion of 22 patients who elected not to undergo PCI or who were withdrawn by their physicians, 3825 participants were included in the intention-to-treat population (1913 in the QFR-guided group and 1912 in the angiography-guided group). The mean age was 62·7 years (SD 10·1), 2699 (70·6%) were men and 1126 (29·4%) were women, 1295 (33·9%) had diabetes, and 2428 (63·5%) presented with an acute coronary syndrome. The 1-year primary endpoint occurred in 110 (Kaplan-Meier estimated rate 5·8%) participants in the QFR-guided group and in 167 (8·8%) participants in the angiography-guided group (difference, -3·0% [95% CI -4·7 to -1·4]; hazard ratio 0·65 [95% CI 0·51 to 0·83]; p=0·0004), driven by fewer myocardial infarctions and ischaemia-driven revascularisations in the QFR-guided group than in the angiography-guided group. INTERPRETATION: In FAVOR III China, among patients undergoing PCI, a QFR-guided strategy of lesion selection improved 1-year clinical outcomes compared with standard angiography guidance. FUNDING: Beijing Municipal Science and Technology Commission, Chinese Academy of Medical Sciences, and the National Clinical Research Centre for Cardiovascular Diseases, Fuwai Hospital.
BACKGROUND: Compared with visual angiographic assessment, pressure wire-based physiological measurement more accurately identifies flow-limiting lesions in patients with coronary artery disease. Nonetheless, angiography remains the most widely used method to guide percutaneous coronary intervention (PCI). In FAVOR III China, we aimed to establish whether clinical outcomes might be improved by lesion selection for PCI using the quantitative flow ratio (QFR), a novel angiography-based approach to estimate the fractional flow reserve. METHODS: FAVOR III China is a multicentre, blinded, randomised, sham-controlled trial done at 26 hospitals in China. Patients aged 18 years or older, with stable or unstable angina pectoris or patients who had a myocardial infarction at least 72 h before screening, who had at least one lesion with a diameter stenosis of 50-90% in a coronary artery with a reference vessel of at least 2·5 mm diameter by visual assessment were eligible. Patients were randomly assigned to a QFR-guided strategy (PCI performed only if QFR ≤0·80) or an angiography-guided strategy (PCI based on standard visual angiographic assessment). Participants and clinical assessors were masked to treatment allocation. The primary endpoint was the 1-year rate of major adverse cardiac events, a composite of death from any cause, myocardial infarction, or ischaemia-driven revascularisation. The primary analysis was done in the intention-to-treat population. The trial was registered with ClinicalTrials.gov (NCT03656848). FINDINGS: Between Dec 25, 2018, and Jan 19, 2020, 3847 patients were enrolled. After exclusion of 22 patients who elected not to undergo PCI or who were withdrawn by their physicians, 3825 participants were included in the intention-to-treat population (1913 in the QFR-guided group and 1912 in the angiography-guided group). The mean age was 62·7 years (SD 10·1), 2699 (70·6%) were men and 1126 (29·4%) were women, 1295 (33·9%) had diabetes, and 2428 (63·5%) presented with an acute coronary syndrome. The 1-year primary endpoint occurred in 110 (Kaplan-Meier estimated rate 5·8%) participants in the QFR-guided group and in 167 (8·8%) participants in the angiography-guided group (difference, -3·0% [95% CI -4·7 to -1·4]; hazard ratio 0·65 [95% CI 0·51 to 0·83]; p=0·0004), driven by fewer myocardial infarctions and ischaemia-driven revascularisations in the QFR-guided group than in the angiography-guided group. INTERPRETATION: In FAVOR III China, among patients undergoing PCI, a QFR-guided strategy of lesion selection improved 1-year clinical outcomes compared with standard angiography guidance. FUNDING: Beijing Municipal Science and Technology Commission, Chinese Academy of Medical Sciences, and the National Clinical Research Centre for Cardiovascular Diseases, Fuwai Hospital.
Authors: Hendrik Wienemann; Marcel C Langenbach; Victor Mauri; Maryam Banazadeh; Konstantin Klein; Christopher Hohmann; Samuel Lee; Isabel Breidert; Alexander Hof; Kaveh Eghbalzadeh; Elmar Kuhn; Marcel Halbach; David Maintz; Stephan Baldus; Alexander Bunck; Matti Adam Journal: J Cardiovasc Dev Dis Date: 2022-04-14