JACC. Cardiovascular interventions · 2026
Fractional Flow Reserve-Guided Renal Artery Stenting in Renovascular Hypertension: 1-Year Results of the FAIR Study.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Li Yuxi, Zheng Rujie, Liu Xu, Zheng Jingang, Lu Chengzhi, Fan Fangfang, Zhou Fude, Qiu Jianxing, Lin Zhiyong, Zhou Shuduo, Liu Zhihao, Liu Shengcong, Yi Tieci, Zhang Long, Weng Haoyu, Wang Beining, Chang Yuxi, Zhou Hui, Ma Dengfeng, Jia Zhi, Xiang Li, Yang Renqiang, Shi Dongmei, Chen Hui, Xu Li, Liu Cun, Kario Kazuomi, Zhang Yan, Li Jianping, FAIR Investigators
Аннотация
BACKGROUND: Whether fractional flow reserve (FFR)-guided revascularization improves outcomes in atherosclerotic renal artery stenosis (ARAS) remains uncertain.
OBJECTIVES: This study will evaluate whether the benefit of FFR-guided stenting sustained at 1 year including renal outcomes.
METHODS: FAIR pilot is an investigator-initiated, multicentre, open-label trial with blinded endpoint adjudication. Adults with ARAS were randomized 1:1 to FFR-guided vs angiography-guided groups. Stenting was performed in the FFR-guided group when FFR <0.80, and it was performed for all in the angiography-guided group regardless of FFR. The percentage changes in ambulatory daytime mean systolic blood pressure (DMSBP), composite index of antihypertensive medicines (CIAHM), and renal outcomes were analyzed for 1 year.
RESULTS: Among all 107 randomized patients, 1-year follow-up was achieved in 50 (93%) in the FFR-guided group and 51 (96%) in the angiography-guided group. At 1 year, DMSBP, CIAHM, and renal outcomes were similar between the groups, while stenting rate was lower with FFR guidance (46% vs 100%, P < 0.01). Patients with FFR <0.80 who underwent stenting experienced the greatest blood pressure reductions (median [IQR] ΔDMSBP: 13 [4, 21] mm Hg at 3 months; 8 [3, 16] mm Hg at 6 months, 7 [0, 16] mm Hg at 12 months; all paired P < 0.05) and sustained declines in CIAHM (2 [0, 5] at 3, 6, and 12 months; all paired P < 0.05). Significant 12-month estimated glomerular filtration rate improvement after stenting was only observed when FFR <0.80, with greater percentage eGFR improvement under quantile regression analysis.
CONCLUSIONS: At the 1-year follow-up, FFR-guided renal artery stenting reduced stent use without loss of blood pressure control or renal safety compared with angiography guidance.
OBJECTIVES: This study will evaluate whether the benefit of FFR-guided stenting sustained at 1 year including renal outcomes.
METHODS: FAIR pilot is an investigator-initiated, multicentre, open-label trial with blinded endpoint adjudication. Adults with ARAS were randomized 1:1 to FFR-guided vs angiography-guided groups. Stenting was performed in the FFR-guided group when FFR <0.80, and it was performed for all in the angiography-guided group regardless of FFR. The percentage changes in ambulatory daytime mean systolic blood pressure (DMSBP), composite index of antihypertensive medicines (CIAHM), and renal outcomes were analyzed for 1 year.
RESULTS: Among all 107 randomized patients, 1-year follow-up was achieved in 50 (93%) in the FFR-guided group and 51 (96%) in the angiography-guided group. At 1 year, DMSBP, CIAHM, and renal outcomes were similar between the groups, while stenting rate was lower with FFR guidance (46% vs 100%, P < 0.01). Patients with FFR <0.80 who underwent stenting experienced the greatest blood pressure reductions (median [IQR] ΔDMSBP: 13 [4, 21] mm Hg at 3 months; 8 [3, 16] mm Hg at 6 months, 7 [0, 16] mm Hg at 12 months; all paired P < 0.05) and sustained declines in CIAHM (2 [0, 5] at 3, 6, and 12 months; all paired P < 0.05). Significant 12-month estimated glomerular filtration rate improvement after stenting was only observed when FFR <0.80, with greater percentage eGFR improvement under quantile regression analysis.
CONCLUSIONS: At the 1-year follow-up, FFR-guided renal artery stenting reduced stent use without loss of blood pressure control or renal safety compared with angiography guidance.