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Clinical Effectiveness of Automated Coronary CT-derived Fractional Flow Reserve: A Chinese Randomized Controlled
Bangjun Guo1, Wei Xing1, Chunhong Hu1
1From 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.).
Insights
Adding coronary CT-derived fractional flow reserve (CT-FFR) to coronary CT angiography (CCTA) reduced invasive coronary angiography (ICA) use by 2.4% within 90 days. This strategy showed similar 1-year major adverse cardiovascular events (MACE) rates but fewer cardiac events.
Area of Science:
- Cardiology
- Radiology
- Medical Imaging
Background:
- Coronary CT-derived fractional flow reserve (CT-FFR) is used for suspected coronary artery disease (CAD).
- Evidence is limited on CT-FFR's impact on invasive coronary angiography (ICA) rates and patient prognosis.
- The study addresses the effectiveness of CT-FFR in a Chinese clinical setting.
Purpose of the Study:
- To evaluate the effectiveness of adding CT-FFR to coronary CT angiography (CCTA) in reducing short-term ICA rates.
- To assess the impact of this combined strategy on major adverse cardiovascular events (MACE) at 90 days and 1 year.
- To explore the prognostic value of CT-FFR in guiding patient management.
Main Methods:
- A multicenter randomized controlled trial involving 5297 patients with 25%-99% coronary stenosis.
- Patients were randomized to CCTA plus automated CT-FFR or CCTA alone.
- Primary endpoint was the 90-day ICA rate; secondary endpoints included 90-day and 1-year MACE and cardiac events.
Main Results:
- The CCTA plus CT-FFR group had a significantly lower 90-day ICA rate (10.0% vs 12.4%, P=.006).
- No significant difference in 90-day or 1-year MACE rates was observed between the groups.
- Fewer cardiac events occurred at 1 year in the CCTA plus CT-FFR group (0.5% vs 1.1%, P=.047).
Conclusions:
- Adding CT-FFR to CCTA effectively reduces the need for invasive coronary angiography in a Chinese real-world setting.
- The strategy demonstrated similar overall MACE rates at one year compared to CCTA alone.
- Further research is needed to confirm the long-term prognostic benefits of CT-FFR guided management.
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.
