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血管造影与血流动力学预测冠状动脉狭窄的自然史:多血管评估 2 亚研究中的血流储备分数与血管造影。

Angiography Versus Hemodynamics to Predict the Natural History of Coronary Stenoses: Fractional Flow Reserve Versus Angiography in Multivessel Evaluation 2 Substudy.

机构信息

Cardiovascular Center, OLV Hospital, Aalst, Belgium (G.C., E.B., P.X., S.F., A.M., J.B., M.V., B.D.B.).

Department of Advanced Biomedical Sciences, University of Naples Federico II, Italy (E.B.).

出版信息

Circulation. 2018 Apr 3;137(14):1475-1485. doi: 10.1161/CIRCULATIONAHA.117.028782. Epub 2017 Nov 21.

DOI:10.1161/CIRCULATIONAHA.117.028782
PMID:29162610
Abstract

BACKGROUND

Among patients with documented stable coronary artery disease and in whom no revascularization was performed, we compared the respective values of angiographic diameter stenosis (DS) and fractional flow reserve (FFR) in predicting natural history.

METHODS

The present analysis included the 607 patients from the FAME 2 trial (Fractional Flow Reserve Versus Angiography in Multivessel Evaluation 2) in whom no revascularization was performed. FFR varied from 0.20 to 1.00 (average 0.74±0.16), and DS (by quantitative coronary analysis) varied from 8% to 98% (average 53±15). The primary end point, defined as vessel-oriented clinical end point (VOCE) at 2 years, was a composite of prospectively adjudicated cardiac death, vessel-related myocardial infarction, vessel-related urgent, and not urgent revascularization. The stenoses were divided into 4 groups according to FFR and %DS values: positive concordance (FFR≤0.80; DS≥50%), negative concordance (FFR>0.80; DS<50%), positive mismatch (FFR≤0.80; DS<50%), and negative mismatch (FFR>0.80; DS≥50%).

RESULTS

The rate of VOCE was highest in the positive concordance group (log rank: X=80.96; =0.001) and lowest in the negative concordance group. The rate of VOCE was higher in the positive mismatch group than in the negative mismatch group (hazard ratio, 0.38; 95% confidence interval, 0.21-0.67; =0.001). There was no significant difference in VOCE between the positive concordance and positive mismatch groups (FFR≤0.80; hazard ratio, 0.77; 95% confidence interval, 0.57-1.09; =0.149) and no significant difference in rate of VOCE between the negative mismatch and negative concordance groups (FFR>0.80; hazard ratio, 1.89; 95% confidence interval, 0.96-3.74; =0.067).

CONCLUSIONS

In patients with stable coronary disease, physiology (FFR) is a more important determinant of the natural history of coronary stenoses than anatomy (DS).

CLINICAL TRIAL REGISTRATION

URL: https://clinicaltrials.gov. Unique identifier: NCT01132495.

摘要

背景

在有明确记录的稳定型冠状动脉疾病患者中,未进行血运重建的患者中,我们比较了血管造影直径狭窄(DS)和血流储备分数(FFR)在预测自然史中的各自价值。

方法

本分析纳入了 FAME 2 试验(多血管评估中血流储备分数与血管造影比较 2 期)中 607 例未进行血运重建的患者。FFR 范围为 0.20 至 1.00(平均 0.74±0.16),DS(通过定量冠状动脉分析)范围为 8%至 98%(平均 53±15)。主要终点定义为 2 年时的血管定向临床终点(VOCE),是前瞻性裁决的心脏死亡、血管相关心肌梗死、血管相关紧急和非紧急血运重建的复合终点。根据 FFR 和 %DS 值将狭窄分为 4 组:阳性一致性(FFR≤0.80;DS≥50%)、阴性一致性(FFR>0.80;DS<50%)、阳性不匹配(FFR≤0.80;DS<50%)和阴性不匹配(FFR>0.80;DS≥50%)。

结果

阳性一致性组的 VOCE 发生率最高(对数秩检验:X=80.96;P=0.001),阴性一致性组的发生率最低。阳性不匹配组的 VOCE 发生率高于阴性不匹配组(危险比,0.38;95%置信区间,0.21-0.67;P=0.001)。阳性一致性和阳性不匹配组的 VOCE 发生率无显著差异(FFR≤0.80;危险比,0.77;95%置信区间,0.57-1.09;P=0.149),阴性不匹配和阴性一致性组的 VOCE 发生率也无显著差异(FFR>0.80;危险比,1.89;95%置信区间,0.96-3.74;P=0.067)。

结论

在稳定型冠状动脉疾病患者中,生理学(FFR)是比解剖学(DS)更能决定冠状动脉狭窄自然史的决定因素。

临床试验注册

网址:https://clinicaltrials.gov。独特标识符:NCT01132495。

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