Clinical Effectiveness of Automated Coronary CT-derived Fractional Flow Reserve: A Chinese Randomized Controlled Trial.
Bangjun Guo, Wei Xing, Chunhong Hu, Yunfei Zha, Xindao Yin, Yongsheng He, Shudong Hu, Yibing Shi, Fajin Lv, Rongpin Wang, Xiaohu Li, Hongmei Gu, Wei Cao, Jinhua Zhang, Yunfeng Zhou, Yi Xu, Meng Chun Jiang, Jian Zhong, Jinggang Zhang, Meng Chen, Baojun Xie, Qian Chen, Wenqiang Diao, Hongyan Qiao, Ying Zhang, Rui Xia, Xinfeng Liu, Shu Min Tao, Tao Zhang, Chang Qing Yin, Wenjun Li, Mengmeng Zhu, Chang Sheng Zhou, Jian Hua Li, Fan Zhou, Chun Yu Liu, Xiao Lei Zhang, Peng Peng Xu, Wen Zhang, Meng Jie Lu, Yu Xiu Liu, Yongyue Wei, Yueqin Chen, Chun Xiang Tang, Guang Ming Lu, Long Jiang Zhang
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{"title":"Clinical Effectiveness of Automated Coronary CT-derived Fractional Flow Reserve: A Chinese Randomized Controlled Trial.","authors":"Bangjun Guo, Wei Xing, Chunhong Hu, Yunfei Zha, Xindao Yin, Yongsheng He, Shudong Hu, Yibing Shi, Fajin Lv, Rongpin Wang, Xiaohu Li, Hongmei Gu, Wei Cao, Jinhua Zhang, Yunfeng Zhou, Yi Xu, Meng Chun Jiang, Jian Zhong, Jinggang Zhang, Meng Chen, Baojun Xie, Qian Chen, Wenqiang Diao, Hongyan Qiao, Ying Zhang, Rui Xia, Xinfeng Liu, Shu Min Tao, Tao Zhang, Chang Qing Yin, Wenjun Li, Mengmeng Zhu, Chang Sheng Zhou, Jian Hua Li, Fan Zhou, Chun Yu Liu, Xiao Lei Zhang, Peng Peng Xu, Wen Zhang, Meng Jie Lu, Yu Xiu Liu, Yongyue Wei, Yueqin Chen, Chun Xiang Tang, Guang Ming Lu, Long Jiang Zhang","doi":"10.1148/radiol.233354","DOIUrl":null,"url":null,"abstract":"<p><p>Background Coronary CT-derived fractional flow reserve (CT-FFR) has been used in patients with suspected coronary artery disease (CAD); however, whether it decreases invasive coronary angiography (ICA) use and affects prognosis remains insufficiently evidenced. Purpose To explore the effectiveness of adding CT-FFR to routine coronary CT angiography (CCTA) on short-term ICA rate and major adverse cardiovascular events (MACE) in a Chinese setting. Materials and Methods A multicenter randomized controlled trial was conducted in 17 Chinese centers, with patient inclusion from May 2021 to September 2021. Eligible individuals with 25%-99% stenosis at CCTA were randomly assigned 1:1 to a strategy of CCTA plus automated CT-FFR or CCTA alone for guiding downstream care. The primary end point was the ICA rate 90 days after enrollment. Secondary end points included 90-day and 1-year MACE rates (comprised of all-cause mortality, nonfatal myocardial infarction, and urgent revascularization) and 1-year cardiac events (comprised of cardiac death, nonfatal myocardial infarction, and urgent revascularization). The Cox proportional hazards model with center effect adjustment was used for survival comparisons. Results A total of 5297 participants (mean age, 63.5 years ± 10.8 [SD]; 3178 male) were included. During the 90-day follow-up, ICA was performed in 263 of 2633 participants (10.0%) in the CCTA plus CT-FFR group and 327 of 2640 participants (12.4%) in the CCTA-alone group (absolute rate difference: -2.40%; 95% CI: -4.10, -0.70; <i>P</i> = .006). The MACE rates at 90 days (0.5% [12 of 2633 participants] vs 0.8% [21 of 2640 participants]; <i>P</i> = .12) and 1 year (2.9% [74 of 2546 participants] vs 2.8% [72 of 2531 participants]; <i>P</i> = .90) were similar for both groups. At 1-year follow-up, fewer cardiac events were observed in the CCTA plus CT-FFR group compared with the CCTA-alone group (0.5% vs 1.1%; adjusted hazard ratio: 0.52; 95% CI: 0.27, 0.99; <i>P</i> = .047). Conclusion CT-FFR added to CCTA led to a lower 90-day ICA rate and similar 1-year MACE rate in a Chinese real-world setting. Further follow-up is warranted to demonstrate the long-term prognostic value of this management approach. © RSNA, 2024 <i>Supplemental material is available for this article.</i> See also the editorial by Pundziute-do Prado in this issue.</p>","PeriodicalId":20896,"journal":{"name":"Radiology","volume":"313 1","pages":"e233354"},"PeriodicalIF":12.1000,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Radiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1148/radiol.233354","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING","Score":null,"Total":0}
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Abstract
Background Coronary CT-derived fractional flow reserve (CT-FFR) has been used in patients with suspected coronary artery disease (CAD); however, whether it decreases invasive coronary angiography (ICA) use and affects prognosis remains insufficiently evidenced. Purpose To explore the effectiveness of adding CT-FFR to routine coronary CT angiography (CCTA) on short-term ICA rate and major adverse cardiovascular events (MACE) in a Chinese setting. Materials and Methods A multicenter randomized controlled trial was conducted in 17 Chinese centers, with patient inclusion from May 2021 to September 2021. Eligible individuals with 25%-99% stenosis at CCTA were randomly assigned 1:1 to a strategy of CCTA plus automated CT-FFR or CCTA alone for guiding downstream care. The primary end point was the ICA rate 90 days after enrollment. Secondary end points included 90-day and 1-year MACE rates (comprised of all-cause mortality, nonfatal myocardial infarction, and urgent revascularization) and 1-year cardiac events (comprised of cardiac death, nonfatal myocardial infarction, and urgent revascularization). The Cox proportional hazards model with center effect adjustment was used for survival comparisons. Results A total of 5297 participants (mean age, 63.5 years ± 10.8 [SD]; 3178 male) were included. During the 90-day follow-up, ICA was performed in 263 of 2633 participants (10.0%) in the CCTA plus CT-FFR group and 327 of 2640 participants (12.4%) in the CCTA-alone group (absolute rate difference: -2.40%; 95% CI: -4.10, -0.70; P = .006). The MACE rates at 90 days (0.5% [12 of 2633 participants] vs 0.8% [21 of 2640 participants]; P = .12) and 1 year (2.9% [74 of 2546 participants] vs 2.8% [72 of 2531 participants]; P = .90) were similar for both groups. At 1-year follow-up, fewer cardiac events were observed in the CCTA plus CT-FFR group compared with the CCTA-alone group (0.5% vs 1.1%; adjusted hazard ratio: 0.52; 95% CI: 0.27, 0.99; P = .047). Conclusion CT-FFR added to CCTA led to a lower 90-day ICA rate and similar 1-year MACE rate in a Chinese real-world setting. Further follow-up is warranted to demonstrate the long-term prognostic value of this management approach. © RSNA, 2024 Supplemental material is available for this article. See also the editorial by Pundziute-do Prado in this issue.