Fractional flow reserve-guided renal artery stenting in atherosclerotic renovascular hypertension: the FAIR randomized trial
Yuxi Li, Jingang Zheng, Chengzhi Lu, Fangfang Fan, Zhihao Liu, Shengcong Liu, Tieci Yi, Long Zhang, Haoyu Weng, Beining Wang, Xu Liu, Hui Zhou, Dengfeng Ma, Jia Zhi, Xiang Li, Renqiang Yang, Dongmei Shi, Hui Chen, Li Xu, Cun Liu, Kazuomi Kario, Yan Zhang, Jianping Li
Abstract
BACKGROUND AND AIMS: The optimal therapy for patients with atherosclerotic renal artery stenosis (ARAS) remains unresolved. This study compared the efficacy of renal fractional flow reserve (FFR)-guided revascularization and traditional angiography-guided revascularization. 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). 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. 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. 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. However, the rate of stenting was significantly lower in the FFR-guided group (46.0% vs 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). CONCLUSIONS: FFR-guided revascularization significantly reduced unnecessary stenting compared with angiography-guided revascularization. Both blood pressure and antihypertensive medication usage decreased significantly after stenting in patients with FFR < 0.80.