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

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.