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

Radiology

From the Departments of Radiology (B.G., J. Zhong, C.S.Z., F.Z., C.Y.L., X.L.Z., P.P.X., C.X.T., G.M.L., L.J.Z.), Cardiology (J.H.L.), and Critical Care Medicine (Y.X.L.), Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, 305 Eastern Zhongshan Rd, Nanjing 210002, China; Department of Radiology, the Third Affiliated Hospital of Soochow University, Soochow University, Changzhou, China (W.X., Jinggang Zhang); Department of Radiology, the First Affiliated Hospital of Soochow University, Suzhou, China (C.H., M.C.); Department of Radiology, Renmin Hospital of Wuhan University, Wuhan, China (Y. Zha, B.X.); Department of Radiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China (X.Y., Q.C.); Department of Radiology, People's Hospital of Maanshan, Maanshan, China (Y.H., W.D.); Department of Medical Imaging, the Affiliated Hospital of Jiangnan University, Wuxi, China (S.H., H.Q.); Department of Diagnostic Radiology, Xuzhou Central Hospital, Xuzhou, China (Y.S., Y. Zhang); Department of Radiology, the First Affiliated Hospital of Chongqing Medical University, Chongqing, China (F.L., R.X.); Department of Medical Imaging, Guizhou Province People's Hospital, Guiyang, China (R.W., X. Liu); Department of Radiology, the First Affiliated Hospital of Anhui Medical University, Hefei, China (X. Li); Medical Imaging Center, Affiliated Hospital of Nantong University, Nantong, China (H.G., S.M.T.); Department of Radiology, the First People's Hospital of Xuzhou, Xuzhou, China (W.C., T.Z.); Department of Medical Imaging, Jiangyin People's Hospital, Jiangyin, China (Jinhua Zhang, C.Q.Y.); Department of Radiology, the First Affiliated Hospital of Wannan Medical College, Wuhu, China (Y. Zhou, W.L.); Department of Radiology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China (Y.X., M.Z.); Department of Radiology, the Affiliated Hospital of Jining Medical University, Jining, China (M.C.J., Y.C.); Shukun (Shanghai) Technology, Shanghai, China (W.Z.); School of Public Health, Shanghai Jiao Tong University School of Medicine, Shanghai, China (M.J.L.); and Center for Public Health and Epidemic Preparedness & Response, Peking University, Beijing, China (Y.W.).

Published: October 2024

A multicenter randomized controlled trial in China investigated the impact of adding coronary CT-derived fractional flow reserve (CT-FFR) to routine coronary CT angiography (CCTA) on the need for invasive coronary angiography (ICA) and major adverse cardiovascular events (MACE) in patients with suspected coronary artery disease (CAD).
The study involved 5,297 participants, showing that the CCTA plus CT-FFR group had a lower ICA rate (10.0%) compared to the CCTA alone group (12.4%) over a 90-day follow-up.
While MACE rates were similar between groups, the CCTA plus CT-FFR approach resulted in fewer cardiac events after one year (0.5%

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; = .006). The MACE rates at 90 days (0.5% [12 of 2633 participants] vs 0.8% [21 of 2640 participants]; = .12) and 1 year (2.9% [74 of 2546 participants] vs 2.8% [72 of 2531 participants]; = .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; = .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 See also the editorial by Pundziute-do Prado in this issue.

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