Fractional flow reserve-guided renal artery stenting in atherosclerotic renovascular hypertension: the FAIR randomized trial.

This study compared the efficacy of renal fractional flow reserve (FFR)-guided revascularization and traditional angiography-guided revascularization.

本研究比较了肾动脉分数血流储备(FFR)引导的血管重建术与传统血管造影引导的血管重建术的疗效。

Methods

In total, 101 patients with ARAS and hypertension were randomly assigned to either the FFR-guided or angiography-guided group (ClinicalTrials.gov identifier: NCT05732077).

共有101名患有肾动脉粥样硬化性狭窄和高血压的患者被随机分配到FFR指导组或血管造影指导组（ClinicalTrials.gov注册号：NCT05732077）。

Stenting was performed in the angiography-guided group regardless of FFR, whereas stenting was only performed in the FFR-guided group for patients with FFR < 0.80.

血管造影指导组无论FFR值如何都进行了支架植入术，而在FFR指导组中，只有FFR<0.80的患者才进行了支架植入术。

The primary endpoints were the percentage changes in ambulatory daytime mean systolic blood pressure (DMSBP) and composite index of antihypertensive medicines (CIAHM) after 3 months.

主要终点是3个月后步行白天平均收缩压（DMSBP）和降压药物复合指数（CIAHM）的百分比变化。

Results

The percentage changes in DMSBP (4% [-2%, 11%] vs 4% [-3%, 10%]; P = .97) and CIAHM (0% [0%, 3%] vs 1% [0%, 4%]; P = .33) did not differ between groups.

两组间DMSBP的百分比变化（4% [-2%, 11%] 对比 4% [-3%, 10%]；P = .97）和CIAHM的百分比变化（0% [0%, 3%] 对比 1% [0%, 4%]；P = .33）没有差异。

However, the rate of stenting was significantly lower in the FFR-guided group (46.0% vs 100.0%, P < .01).

然而，在FFR指导组中，支架植入率显著较低（46.0%对比100.0%，P<.01）。

Moreover, compared with the findings in patients with FFR ≥ 0.80 who did not receive stenting, stenting was beneficial in patients with FFR < 0.80 (adjusted mean DMSBP reduction, 6.2 [95% confidence interval{CI}, 0.6-11.9] mmHg; mean CIAHM reduction, 3.1 [95% CI, 1.5-4.7]), but not in those with FFR ≥ 0.80 (1.4 [95% CI, -4.5-7.2] mmHg, and 0.7 [95% CI, -1.1-2.5], respectively).

此外，与未接受支架植入的FFR≥0.80患者的研究结果相比，FFR<0.80的患者接受支架植入是有益的（调整后的平均DMSBP降低6.2 [95%置信区间{CI}, 0.6-11.9] mmHg；平均CIAHM降低3.1 [95% CI, 1.5-4.7]），但在FFR≥0.80的患者中则没有益处（分别为1.4 [95% CI, -4.5-7.2] mmHg和0.7 [95% CI, -1.1-2.5]）。

Conclusions

FFR-guided revascularization significantly reduced unnecessary stenting compared with angiography-guided revascularization.

与血管造影指导下的血运重建相比，FFR指导下的血运重建显著减少了不必要的支架植入。

Both blood pressure and antihypertensive medication usage decreased significantly after stenting in patients with FFR < 0.80.

在FFR小于0.80的患者中，支架植入后血压和抗高血压药物使用均显著降低。