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: X²=80.96; P=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; P=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; P=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; P=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.

中文翻译：

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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

背景：在已记录有稳定冠状动脉疾病且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）和分流储备（FFR）的各自值，以预测自然病史。

方法：本分析包括来自FAME 2试验（多支血管评价中的分数流量储备对血管造影术2）的607例患者，未进行血管重建。FFR从0.20到1.00（平均0.74±0.16）不等，DS（通过定量冠状动脉分析）从8％到98％（平均53±15）不等。主要终点定义为2年时的以血管为导向的临床终点（VOCE），它是前瞻性判定的心源性死亡，与血管相关的心肌梗塞，与血管相关的紧急和非紧急血运重建的综合指标。根据FFR和％DS值将狭窄分为4组：正一致性（FFR≤0.80;DS≥50％），负一致性（FFR> 0.80; DS <50％），正失配（FFR≤0.80; DS < 50％）和负不匹配（FFR> 0.80；DS≥50％）。

结果：阳性一致性组的VOCE发生率最高（对数等级：X ² = 80.96；P = 0.001），阴性一致性组的VOCE发生率最低。阳性失配组的VOCE发生率高于阴性失配组（危险比，0.38； 95％置信区间，0.21-0.67；P = 0.001）。正一致性和正错配组之间的VOCE差异无统计学意义（FFR≤0.80；危险比为0.77； 95％置信区间为0.57–1.09；P = 0.149），负错配组的VOCE比率也无显着差异。负一致性组（FFR> 0.80；危险比为1.89； 95％置信区间为0.96-3.74；P = 0.067）。

结论：在患有稳定型冠状动脉疾病的患者中，生理学（FFR）是决定冠状动脉狭窄自然史的重要因素，而解剖学（DS）更为重要。

临床试验注册： URL：https://clinicaltrials.gov。唯一标识符：NCT01132495。