Clinical Effectiveness of Automated Coronary CT-derived Fractional Flow Reserve: A Chinese Randomized Controlled Trial

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.

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Journal
Radiology
Published
2024-10-01
DOI
https://doi.org/10.1148/radiol.233354
Citations
18
Primary Topic
Cardiac Imaging and Diagnostics
Type
article
Field-Weighted Citation Impact
7.28

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article

Clinical Effectiveness of Automated Coronary CT-derived Fractional Flow Reserve: A Chinese Randomized Controlled Trial

Wenhui Diao, Yunfei Zha, Chang Yin, Qian Chen et al.
18 citations
Radiology
Cardiac Imaging and Diagnostics
7.28
article

Clinical Effectiveness of Automated Coronary CT-derived Fractional Flow Reserve: A Chinese Randomized Controlled Trial

Wenhui Diao, Yunfei Zha, Chang Yin, Qian Chen, Wei Xing, Jinggang Zhang, Hongmei Gu, Shudong Hu, Peng Xu, Shu Min Tao, X. Li, Xindao Yin, Long Jiang Zhang, Ying E. Zhang, Mengmeng Zhu, Hongyan Qiao, Jian Zhong, Bangjun Guo, Guangming Lu, Meng Chen, Yongyue Wei, Tao Zhang, Jinhua Zhang, Chunhong Hu, Yi Xu, Fan Zhou, Wei Cao, Rui Xia, Chang Sheng Zhou, Yueqin Chen, Chun Xiang Tang, Yunfeng Zhou, Rongpin Wang, Yuxiu Liu, Xiao Lei Zhang, Baojun Xie, Yibing Shi, Meng Jie Lu, Wen Jie Zhang, Meng Jiang, Fajin Lv, Yongsheng He, Jian Hua Li, Chun Yu Liu, Wenjun Li, Xinfeng Liu
article en
18 citations

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; <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.

RadiologyVol. 313(1)
Soochow University (CN)
National Natural Science Foundation of China, National Key Research and Development Program of China
Openalex Percentile: Top 2%
Cardiac Imaging and Diagnostics
7.28
DOISourceOpenAlex
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