Angiography-Based Physiology to Guide Coronary Revascularization.

Data regarding revascularization guided by vessel fractional flow reserve (vFFR), derived from three-dimensional quantitative coronary angiography without the need for a pressure wire or hyperemic agent, as compared with pressure-wire-based fractional flow reserve (FFR), are lacking.

与基于压力导丝的分数血流储备（FFR）相比，缺乏关于无需压力导丝或血管扩张剂的三维定量冠状动脉造影衍生的血管分数血流储备（vFFR）指导的血运重建数据。

Methods

We conducted an international, open-label, randomized, noninferiority trial at 37 sites in Europe.

我们在欧洲的37个地点进行了一项国际、开放标签、随机、非劣效试验。

Patients with intermediate coronary-artery lesions (diameter stenosis of 30 to 80%) who presented with chronic or acute coronary syndromes were randomly assigned in a 1:1 ratio to undergo either vFFR-guided or FFR-guided revascularization of the intermediate coronary-artery lesions.

患有中度冠状动脉病变（直径狭窄30%至80%）且表现为慢性或急性冠状动脉综合征的患者，按照1:1的比例随机分配，接受vFFR引导或FFR引导的中度冠状动脉病变血运重建。

The primary end point was a composite of death from any cause, any myocardial infarction, or any revascularization at 1 year.

主要终点是1年内因任何原因死亡、任何心肌梗死或任何血运重建的复合终点。

The noninferiority margin was 3.0 percentage points.

非劣效性边界是3.0个百分点。

Results

The primary end point was assessed in 1116 patients in the vFFR group and 1095 in the FFR group.

主要终点在vFFR组的1116名患者和FFR组的1095名患者中进行了评估。

The mean age of the patients was 67 years, 24.3% were women, 18.7% presented with an acute coronary syndrome, and 26.6% had diabetes mellitus.

患者的平均年龄为67岁，24.3%为女性，18.7%表现为急性冠脉综合征，26.6%患有糖尿病。

At 1 year, a primary end-point event had occurred in 80 patients (Kaplan-Meier estimate, 7.5%) in the vFFR group and in 79 patients (Kaplan-Meier estimate, 7.5%) in the FFR group (risk difference, -0.02 percentage points; 95% confidence interval, -2.25 to 2.21; P = 0.004 for noninferiority).

在1年时，vFFR组有80名患者发生了主要终点事件（Kaplan-Meier估计为7.5%），FFR组有79名患者发生了主要终点事件（Kaplan-Meier估计为7.5%）（风险差异为-0.02个百分点；95%置信区间为-2.25到2.21；P=0.004，证明非劣效性）。

The incidenceof serious adverse events appeared to be similar in the two groups.

两组中严重不良事件的发生率似乎相似。

Conclusions

Among patients with intermediate coronary lesions, vFFR-guided revascularization was noninferior to FFR-guided revascularization with respect to a composite of death, myocardial infarction, or revascularization at 1 year.

在中度冠状动脉病变患者中，与基于FFR的血运重建相比，基于vFFR的血运重建在1年内死亡、心肌梗死或再次血运重建的复合终点方面具有非劣效性。

(Funded by Pie Medical Imaging and Siemens Healthineers; FAST III ClinicalTrials.gov number, NCT04931771.).

(该研究由Pie Medical Imaging和Siemens Healthineers资助；FAST III的ClinicalTrials.gov编号为NCT04931771。)