Fractional flow reserve-guided percutaneous coronary intervention versus medical therapy for stable coronary artery disease: long-term results of the FAME 2 trial.

In the Fractional Flow Reserve versus Angiography for Multivessel Evaluation 2 trial, patients with hemodynamically significant stenoses (fractional flow reserve (FFR) ≤ 0.80) were randomized to receive FFR-guided percutaneous coronary intervention (PCI) plus medical therapy (n = 447) or medical therapy alone (n = 441).

在分数流量储备与血管造影多血管评估2试验中，血流动力学显著狭窄（分数流量储备（FFR）≤0.80）的患者被随机分配接受FFR指导的经皮冠状动脉介入治疗（PCI）加药物治疗（n = 447）或单独药物治疗（n = 441）。

At 5 years, FFR-guided PCI reduced the risk of the primary composite outcome of time to death, myocardial infarction or urgent revascularization, largely because of fewer urgent revascularizations.

在5年时，基于功能性血流储备（FFR）指导的经皮冠状动脉介入治疗（PCI）降低了主要复合终点事件（包括死亡、心肌梗死或紧急血运重建）的风险，这主要是由于紧急血运重建的次数减少。

We now report the long-term clinical outcomes from this trial. Sixteen hospitals, contributing 748 randomized patients (161 women, 21.5%), participated in the long-term follow-up.

我们现在报告了这项试验的长期临床结果。共有16家医院参与了长期随访，共纳入了748名随机患者（其中女性161名，占21.5%）。

The primary composite outcome was analyzed hierarchically using the unstratified win ratio, which addressed differential missingness of data on nonfatal outcomes in deceased patients by prioritizing comparisons on time to death.

主要复合终点事件采用非分层胜利比法进行层次分析，该方法通过优先比较死亡时间来解决死亡患者非致命性结果数据差异性缺失的问题。

At a median follow-up of 11.2 years, the primary endpoint occurred in 150 of 447 patients (33.6%) in the PCI group versus 182 of 441 (41.3%) in the medical therapy group.

中位随访时间为11.2年，主要终点事件在447名PCI组患者中有150例（33.6%）发生，而在441名内科治疗组患者中有182例（41.3%）发生。

PCI was superior in 29.2% of comparisons, medical therapy in 23.3%, and the two groups were tied in 47.5%, resulting in a win ratio of 1.25 in favor of PCI (95% confidence interval(CI) 1.01-1.56, P = 0.043).

PCI 在 29.2% 的比较中表现更优，药物治疗在 23.3% 中表现更佳，而两组在 47.5% 的比较中效果相当，因此 PCI 的胜出比为 1.25（95% 置信区间（CI）1.01-1.56，P = 0.043）。

The corresponding win difference was 5.9% (95% CI 0.2-11.6), and the number needed to treat was 17 (95% CI 9-500).

相应的胜出差异为 5.9%（95% CI 0.2-11.6），需要治疗的人数为 17（95% CI 9-500）。

Win ratios were 0.88 for all-cause death (95% CI 0.66-1.17), 1.50 for myocardial infarction (95% CI 0.98-2.31) and 4.57 for urgent revascularization (95% CI 2.53-8.24).

全因死亡的胜率比为0.88（95%置信区间0.66-1.17），心肌梗死的胜率比为1.50（95%置信区间0.98-2.31），紧急血管重建的胜率比为4.57（95%置信区间2.53-8.24）。

During long-term follow-up, FFR-guided PCI in patients with stable CAD and hemodynamically significant stenoses reduced the composite of death, myocardial infarction or urgent revascularization, primarily because of fewer urgent revascularizations.

在长期随访期间，对于稳定型冠状动脉疾病患者和血流动力学显著狭窄患者，基于FFR的PCI减少了死亡、心肌梗死或紧急血管重建的复合终点，主要是由于减少了紧急血管重建的发生。

These long-term findings reaffirm the efficacy of FFR-guided PCI over medical therapy in patients with stable CAD.

这些长期研究结果再次确认了在稳定性冠状动脉疾病患者中，基于血流储备分数（FFR）指导的经皮冠状动脉介入治疗（PCI）相较于药物治疗的有效性。

ClinicalTrials.gov registration: NCT06159231 .

ClinicalTrials.gov 注册号：NCT06159231。