A randomized unblinded trial to compare effects of intensive versus conventional lipid-lowering therapy in patients undergoing renal artery stenting

Abstract

Background: Although current guidelines recommend the use of statins for severe atherosclerotic renal artery stenosis (ARAS), the renal protection of intensive lipid-lowering therapy in patients with ARAS who underwent stent placement remains uncertain. The aim of this study was to compare the renal-protective effect of intensive lipid lowering with that of conventional lipid lowering in patients with ARAS undergoing stent placement.

Methods: A total 150 patients with severe ARAS undergoing stent placement were randomly (1:1) assigned to receive intensive lipid lowering [target low-density lipoprotein cholesterol (LDL-C) <70mg/dL] or conventional lipid lowering (target LDL-C ≥70mg/dL, <128mg/dL). All patients received rosuvastatin. We adjusted LDL-C to the goal within two months after renal stenting and maintained stability. The primary endpoint was the change in estimated glomerular filtration rate (eGFR) at 12 months.

Results: During the study period, LDL-C was lower in the patients with intensive lipid lowering than with conventional lipid lowering (at 12 months 58.0±11.6 vs 85.1±15.5mg/dL, p<0.001). At 12-month follow-up, eGFR (91.8±30.2 vs 78.5±19.5)mL/min·1.73m², p=0.002) and the increase in eGFR compared to baseline [14.8(IQR, 4.1, 26.7) vs -0.4(IQR, -9.5, 8.0)mL/min·1.73m², p<0.001] were higher in the patients with intensive lipid lowering than with conventional lipid lowering. Urinary albumin-creatinine ratio [42.2(IQR, 20.0, 60.9) vs 60.8(IQR, 26.8, 121.6)mg/g, p=0.032] was lower and the decrease in urinary albumin-creatinine ratio compared to baseline [27.4(IQR, 3.0, 53.8) vs -3.1(IQR, -17.3, 30.9)mg/g, p=0.001] was higher in the patients with intensive lipid lowering than with conventional lipid lowering. The restenosis rate (3.1% vs 3.4%, p=0.711) and major clinical events (6.8% vs 11.0%, p=0.37) were similar between the two groups.

Conclusions: In patients with severe ARAS undergoing stent placement, intensive lipid lowering showed significant benefits in renal protection over conventional lipid-lowering therapy.

Keywords: Low-density lipoprotein cholesterol; Renal artery stenosis; Rosuvastatin; Stent placement.