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

IF 12.1 1区 医学 Q1 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING
Radiology Pub Date : 2024-10-01 DOI:10.1148/radiol.233354
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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引用次数: 0

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.

自动冠状动脉 CT 导出分数血流储备的临床疗效:中国随机对照试验。
背景 冠状动脉 CT 导出分数血流储备(CT-FFR)已被用于疑似冠状动脉疾病(CAD)患者;然而,它是否能减少有创冠状动脉造影(ICA)的使用并影响预后仍缺乏足够的证据。目的 探讨在常规冠状动脉 CT 血管造影术(CCTA)的基础上增加 CT-FFR 对短期 ICA 率和主要不良心血管事件(MACE)的影响。材料与方法 一项多中心随机对照试验在中国 17 个中心进行,患者纳入时间为 2021 年 5 月至 2021 年 9 月。符合条件的 CCTA 狭窄率为 25%-99% 的患者被 1:1 随机分配到 CCTA 加自动 CT-FFR 或单纯 CCTA 的策略中,以指导下游治疗。主要终点是入组后 90 天的 ICA 率。次要终点包括 90 天和 1 年 MACE 率(包括全因死亡率、非致命性心肌梗死和紧急血运重建)和 1 年心脏事件(包括心源性死亡、非致命性心肌梗死和紧急血运重建)。在进行生存比较时,采用了带中心效应调整的 Cox 比例危险模型。结果 共纳入 5297 名参与者(平均年龄为 63.5 岁 ± 10.8 [SD];3178 名男性)。在 90 天的随访期间,CCTA 加 CT-FFR 组的 2633 名参与者中有 263 人(10.0%)进行了 ICA,而单独 CCTA 组的 2640 名参与者中有 327 人(12.4%)进行了 ICA(绝对比率差异:-2.40%;95% CI:-4.10, -0.70;P = .006)。两组 90 天(0.5% [2633 名参与者中的 12 人] vs 0.8% [2640 名参与者中的 21 人];P = .12)和 1 年(2.9% [2546 名参与者中的 74 人] vs 2.8% [2531 名参与者中的 72 人];P = .90)的 MACE 发生率相似。随访 1 年时,CCTA 加 CT-FFR 组比单用 CCTA 组观察到的心脏事件更少(0.5% vs 1.1%;调整后危险比:0.52;95% CI:0.27, 0.99;P = .047)。结论 在中国的实际情况中,CCT-FFR 加到 CCTA 中可降低 90 天 ICA 发生率和相似的 1 年 MACE 发生率。需要进一步随访以证明这种管理方法的长期预后价值。© RSNA, 2024 这篇文章有补充材料。另请参阅本期 Pundziute-do Prado 的社论。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Radiology
Radiology 医学-核医学
CiteScore
35.20
自引率
3.00%
发文量
596
审稿时长
3.6 months
期刊介绍: Published regularly since 1923 by the Radiological Society of North America (RSNA), Radiology has long been recognized as the authoritative reference for the most current, clinically relevant and highest quality research in the field of radiology. Each month the journal publishes approximately 240 pages of peer-reviewed original research, authoritative reviews, well-balanced commentary on significant articles, and expert opinion on new techniques and technologies. Radiology publishes cutting edge and impactful imaging research articles in radiology and medical imaging in order to help improve human health.
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