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稳定型心绞痛患者冠状动脉 CT 血管造影衍生的血流储备分数对 3 年结局的预测价值。

Prognostic Value of Coronary CT Angiography-derived Fractional Flow Reserve on 3-year Outcomes in Patients with Stable Angina.

机构信息

From the Department of Cardiology, University Hospital of Southern Denmark, Esbjerg, Finsensgade 35, Esbjerg DK-6700, Denmark (K.T.M., A.R., N.P.R.S.); Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark (B.L.N., J.M.J., E.L.G., H.E.B.); Department of Clinical Medicine, Faculty of Health (B.L.N., E.L.G.), and Department of Public Health, Section for Biostatistics (E.P.), Aarhus University, Aarhus, Denmark; Department of Cardiology, Odense University Hospital, Odense, Denmark (K.A.Ø., H.M.); Department of Cardiology, Liverpool Centre for Cardiovascular Science, Liverpool Heart and Chest Hospital, Liverpool, United Kingdom (T.A.F.); Departments of Cardiovascular Medicine and Radiology, Stanford University, Stanford, Calif (K.N.); Division of Cardiology, Department of Medicine, Duke University, Durham, NC (M.R.P.); HeartFlow Inc, Mountain View, Calif (C.R., S.M.); Department of Radiology, Providence Health Care, St. Paul's Hospital, University of British Columbia, Vancouver, Canada (J.L.); and Department of Regional Health Research, University of Southern Denmark, Esbjerg, Denmark (N.P.R.S.).

出版信息

Radiology. 2023 Sep;308(3):e230524. doi: 10.1148/radiol.230524.

Abstract

Background The prognostic value of coronary CT angiography (CTA)-derived fractional flow reserve (FFR) beyond 1-year outcomes and in patients with high levels of coronary artery calcium (CAC) is uncertain. Purpose To assess the prognostic value of coronary CTA-derived FFR test results on 3-year clinical outcomes in patients with coronary stenosis and among a subgroup of patients with high levels of CAC. Materials and Methods This study represents a 3-year follow-up of patients with new-onset stable angina pectoris who were consecutively enrolled in the Assessing Diagnostic Value of Noninvasive CT-FFR in Coronary Care, known as ADVANCE (ClinicalTrials.gov: NCT02499679) registry, between December 2015 and October 2017 at three Danish sites. A high CAC was defined as an Agatston score of at least 400. A lesion-specific coronary CTA-derived FFR value of 2 cm with distal-to-stenosis value at or below 0.80 represented an abnormal test result. The primary end point was a composite of all-cause death and nonfatal spontaneous myocardial infarction. Event rates were estimated using the one-sample binomial model, and relative risk was compared between participants stratified by results of coronary CTA-derived FFR. Results This study included 900 participants: 523 participants with normal results (mean age, 64 years ± 9.6 [SD]; 318 male participants) and 377 with abnormal results from coronary CTA-derived FFR (mean age, 65 years ± 9.6; 264 male participants). The primary end point occurred in 11 of 523 (2.1%) and 25 of 377 (6.6%) participants with normal and abnormal coronary CTA-derived FFR results, respectively (relative risk, 3.1; 95% CI: 1.6, 6.3; < .001). In participants with high CAC, the primary end point occurred in four of 182 (2.2%) and 19 of 212 (9.0%) participants with normal and abnormal coronary CTA-derived FFR results, respectively (relative risk, 4.1; 95% CI: 1.4, 11.8; = .001). Conclusion In individuals with stable angina, a normal coronary CTA-derived FFR test result identified participants with a low 3-year risk of all-cause death or nonfatal spontaneous myocardial infarction, both in the overall cohort and in participants with high CAC scores. Clinical trial registration no. NCT02499679 Published under a CC BY 4.0 license. See also the editorial by Sinitsyn in this issue.

摘要

背景

冠状动脉 CT 血管造影(CTA)衍生的血流储备分数(FFR)在 1 年以上的预后和高冠状动脉钙(CAC)水平患者中的预后价值尚不确定。目的:评估冠状动脉 CTA 衍生的 FFR 检查结果在伴有冠状动脉狭窄的患者和 CAC 水平较高的亚组患者中对 3 年临床结局的预后价值。材料和方法:本研究是 ADVANCE(ClinicalTrials.gov:NCT02499679)注册登记处在 2015 年 12 月至 2017 年 10 月期间在丹麦的三个地点连续纳入新发稳定型心绞痛患者的 3 年随访,共纳入 900 名患者:523 名患者冠状动脉 CTA 衍生 FFR 检查结果正常(平均年龄 64 岁±9.6[标准差];318 名男性患者)和 377 名冠状动脉 CTA 衍生 FFR 检查结果异常(平均年龄 65 岁±9.6;264 名男性患者)。高 CAC 定义为 Agatston 评分至少 400。病变特异性冠状动脉 CTA 衍生 FFR 值为 2cm,狭窄远端值在 0.80 或以下代表异常检查结果。主要终点是全因死亡和非致死性自发性心肌梗死的复合终点。使用单样本二项式模型估计事件发生率,并比较根据冠状动脉 CTA 衍生 FFR 结果分层的参与者之间的相对风险。结果:在冠状动脉 CTA 衍生 FFR 检查结果正常的 523 名患者中,11 名(2.1%)和 377 名异常的患者中,25 名(6.6%)发生了主要终点事件(相对风险,3.1;95%CI:1.6,6.3;<.001)。在 CAC 水平较高的患者中,在冠状动脉 CTA 衍生 FFR 检查结果正常的 182 名患者中,有 4 名(2.2%)和异常的 212 名患者中,有 19 名(9.0%)发生了主要终点事件(相对风险,4.1;95%CI:1.4,11.8;=0.001)。结论:在稳定型心绞痛患者中,正常的冠状动脉 CTA 衍生 FFR 检查结果可识别出 3 年内全因死亡或非致死性自发性心肌梗死风险较低的患者,在整个队列和 CAC 评分较高的患者中均如此。临床试验注册号:NCT02499679 基于知识共享署名 4.0 许可发布。请参见本期 Sinitsyn 的社论。

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