Atherosclerotic renal artery stenosis (ARAS) represents one of the main causes of secondary hypertension (HTN) and is associated with a higher risk of renal deterioration and cardiovascular events. However, contemporary randomized trials have failed to demonstrate a clear benefit of systematic stenting compared with optimal medical therapy.
One of the main criticisms of these studies was the inclusion of patients with angiographically significant stenoses that were likely not functionally significant. In this context, physiological assessment using FFR, already widely validated in the coronary territory, emerges as a potential strategy for the proper identification of functionally significant lesions.
The FAIR study, recently published in the European Heart Journal, addresses this question by comparing an FFR-guided renal revascularization strategy with stenting versus a standard angiography-guided strategy in patients with renal artery stenosis (RAS) and uncontrolled hypertension.
A total of 101 patients with ≥50% stenosis in at least one main renal artery (diameter ≥4 mm) and uncontrolled HTN despite the use of ≥2 antihypertensive medications were included. Patients were randomized 1:1 to an angiography-guided strategy (stenting regardless of FFR value) or an FFR-guided strategy (stenting only if FFR <0.80). Renal hyperemia was induced with selectively injected dopamine.
The primary endpoints were the percentage change in mean daytime systolic blood pressure (mDSBP) measured by ambulatory monitoring and the change in the composite antihypertensive medication index (CAMI) at 3 months.
No differences were observed between both strategies in the percentage reduction of mDSBP (4% vs 4%; p=0.97) or in CAMI (0% vs 1%; p=0.33). The stenting rate was significantly lower (54% fewer procedures) in the FFR-guided group (46.0% vs 100.0%; p<0.01).
Among patients treated with stents who had FFR <0.80, compared with those with FFR ≥0.80 who did not undergo stenting, an adjusted reduction in mDSBP of 6.2 mmHg (95% CI 0.6–11.9; p=0.04) and a decrease in CAMI of 3.1 (95% CI 1.5–4.7; p<0.01) were observed.
The correlation between angiographic stenosis severity and FFR was low (r = −0.21; p=0.17), highlighting the limited ability of angiography to define functional lesion relevance. According to ROC analysis, an FFR cutoff of 0.78 was identified as optimal for predicting significant blood pressure improvement (AUC 0.78).
Conclusions: impact of FFR-guided strategy on renal stenting and blood pressure control
The FAIR study showed that an FFR-guided strategy in atherosclerotic renal artery stenosis significantly reduces the number of implanted stents without compromising blood pressure control, suggesting a clinical benefit of stenting in patients with FFR <0.80. Although this is a pilot study with a small sample size and short follow-up, it supports the incorporation of functional criteria into decision-making for ARAS.
Original itle: Fractional flow reserve-guided renal artery stenting in atherosclerotic renovascular hypertension: the FAIR randomized trial.
Reference: Li Y, Zheng J, Lu C, Fan F, Liu Z, Liu S, Yi T, Zhang L, Weng H, Wang B, Liu X, Zhou H, Ma D, Jia Z, Xiang L, Yang R, Shi D, Chen H, Xu L, Liu C, Kario K, Zhang Y, Li J. Fractional flow reserve-guided renal artery stenting in atherosclerotic renovascular hypertension: the FAIR randomized trial. Eur Heart J. 2026 Feb 11;47(6):761-769. doi: 10.1093/eurheartj/ehaf746. PMID: 41056188.
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