Physiology vs angiography-guided percutaneous coronary intervention in transcatheter aortic valve implantation: the FAITAVI trial.

Fractional flow reserve (FFR) may improve the identification of ischaemia-producing lesions compared to angiographic assessment alone, but data in the TAVI population are lacking.

与单独的血管造影评估相比，分数流量储备（FFR）可能有助于更好地识别产生缺血的病变，但在TAVI人群中缺乏相关数据。

Methods

In this multicentric, open-label, randomized, superiority trial with blind adjudication of adverse events, patients with aortic stenosis and intermediate coronary lesions undergoing TAVI were randomized 1:1 to FFR-guided or angiography-guided percutaneous coronary intervention (PCI).

在这项多中心、开放标签、随机、优效试验中，对不良事件进行了盲法评定，研究对象为接受经导管主动脉瓣置换术（TAVI）的主动脉瓣狭窄和中度冠状动脉病变患者，这些患者被随机分为1:1，接受基于功能性血流储备（FFR）指导或基于血管造影指导的经皮冠状动脉介入治疗（PCI）。

The trial was registered at ClinicalTrials.gov (NCT03360591).

该试验已在ClinicalTrials.gov注册（NCT03360591）。

All randomized patients were included in the primary analysis according to the intention-to-treatprinciple.

所有随机患者均根据意向治疗原则纳入主要分析。

The primary endpoint was a major adverse cardiac and cerebrovascular event (MACCE) at 12 months of follow-up, defined as a composite of all-cause death, myocardial infarction, ischaemia-driven target vessel revascularization, disabling stroke, or major bleeding.

主要终点是在随访12个月时的主要不良心脏和脑血管事件（MACCE），定义为全因死亡、心肌梗死、缺血驱动的目标血管血运重建、致残性中风或重大出血的复合终点。

Results

A total of 320 patients were enrolled across 15 Italian centres.

共有320名患者在15个意大利中心参与了研究。

The median age of the patients was 86 years [interquartile range (IQR) 83-90], and the median STS score was 3% (IQR 2-5).

患者的中位年龄为86岁[四分位数间距(IQR) 83-90岁]，中位STS评分为3%(IQR 2-5%)。

The median SYNTAX score was 7 (IQR 5-11).

SYNTAX评分的中位数为7（四分位数间距5-11）。

FFR-guided PCI was associated with a significantly lower rate of MACCE at 12 months compared with angiography-guided PCI (8.5% vs 16.0%; hazard ratio.52; 95% confidence interval.27-.99; P = .047).

与血管造影引导的PCI相比，FFR引导的PCI在12个月时的MACCE发生率显著降低（8.5%对比16.0%；风险比0.52；95%置信区间0.27-0.99；P = .047）。

The difference in the primary endpoint was primarily driven by a reduction in all-cause mortality (hazard ratio.31; 95% confidence interval.10-.96).

主要终点的差异主要是由于全因死亡率的降低（风险比0.31；95%置信区间0.10-0.96）。

Other components of the composite were numerically lower but not statistically significant.

复合终点的其他组成部分在数值上有所降低，但没有统计学意义。

Conclusions

In patients undergoing TAVI with intermediate coronary lesions, FFR-guided PCI was associated with a reduced risk of MACCE at 12 months.

在接受经导管主动脉瓣置换术（TAVI）治疗的中度冠状动脉病变患者中，功能性血流储备（FFR）指导下的经皮冠状动脉介入治疗（PCI）与12个月时主要不良心血管和脑血管事件（MACCE）风险降低相关。

These findings support a physiology-based revascularization strategy in this frail, elderly population.

这些发现支持在这一脆弱、老年患者群体中采用基于生理学的血运重建策略。