基于冠状动脉 CT 计算的血流储备分数的临床效果：一项中国的随机对照试验。
Clinical Effectiveness of Automated Coronary CT-derived Fractional Flow Reserve: A Chinese Randomized Controlled Trial.
机构信息
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.).
出版信息
Radiology. 2024 Oct;313(1):e233354. doi: 10.1148/radiol.233354.
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.
背景
冠状动脉 CT 衍生的血流储备分数（CT-FFR）已用于疑似冠状动脉疾病（CAD）患者；然而，其是否降低了有创冠状动脉造影（ICA）的使用率并影响预后，仍证据不足。目的：在中国人中，探讨 CT-FFR 联合常规冠状动脉 CT 血管造影（CCTA）对短期 ICA 率和主要不良心血管事件（MACE）的影响。材料与方法：在 17 家中国中心进行了一项多中心随机对照试验，患者入选时间为 2021 年 5 月至 2021 年 9 月。对 CCTA 显示狭窄程度 25%-99%的患者进行随机 1:1 分组，一组采用 CCTA 联合自动 CT-FFR 指导后续治疗，另一组仅采用 CCTA 指导后续治疗。主要终点为入组后 90 天的 ICA 率。次要终点包括 90 天和 1 年的 MACE 率（包括全因死亡率、非致死性心肌梗死和紧急血运重建）和 1 年的心脏事件（包括心脏死亡、非致死性心肌梗死和紧急血运重建）。采用中心效应校正的 Cox 比例风险模型进行生存比较。结果：共纳入 5297 例患者（平均年龄 63.5 岁±10.8[标准差]；3178 例男性）。在 90 天随访期间，CCTA 联合 CT-FFR 组有 263 例（10.0%）和 CCTA 组有 327 例（12.4%）进行了 ICA（绝对差异：-2.40%；95%置信区间：-4.10，-0.70； =.006）。90 天时的 MACE 发生率在两组间相似（0.5%[2633 例中的 12 例]与 0.8%[2640 例中的 12 例]； =.12），1 年时也相似（2.9%[2546 例中的 74 例]与 2.8%[2531 例中的 72 例]； =.90）。在 1 年随访时，CCTA 联合 CT-FFR 组的心脏事件发生率低于 CCTA 组（0.5%比 1.1%；调整后的危险比：0.52；95%置信区间：0.27，0.99； =.047）。结论：在中国人中，与单纯 CCTA 相比，CT-FFR 联合 CCTA 可降低 90 天 ICA 率，且 1 年 MACE 率相似。需要进一步随访以证实这种管理方法的长期预后价值。©RSNA，2024 另请参阅本期 Pundziute-do Prado 的社论。
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