For patients with atherosclerotic renal artery stenosis, the results of randomized controlled trials published in recent years have failed to demonstrate that renal artery stenting is superior to optimal medical therapy. However, these studies still have limitations.
Fractional flow reserve (FFR) has been extensively studied in coronary artery disease, and it has been established that FFR-guided revascularization is superior to both angiography-guided percutaneous coronary intervention and medical therapy alone. Whether FFR can guide interventional treatment in patients with renal artery stenosis and hypertension is currently a hot topic in the field of renal artery stenosis research.
Eligible patients meeting the inclusion criteria were enrolled. Pharmacologically induced FFR values were measured as the baseline. Patients with FFR ≥ 0.8 were randomly assigned to either the medical therapy group or the stenting group, while patients with FFR \< 0.8 underwent stent implantation. Changes in eGFR, 24-hour systolic blood pressure, and 24-hour diastolic blood pressure from baseline to 12 months were compared among the groups.
Renal artery diameter stenosis ≥60%;
Office systolic blood pressure ≥ 160 mmHg and/or office diastolic blood pressure ≥ 100 mmHg on at least two separate days without antihypertensive medication, or office systolic blood pressure ≥ 140 mmHg and/or office diastolic blood pressure ≥ 90 mmHg while on three antihypertensive drugs at conventional doses;
Serum creatinine < 264 μmol/L (3.0 mg/dL);
Affected kidney length ≥ 7.0 cm, with residual glomerular filtration rate (GFR) ≥ 10 mL/min;
Unstable clinical condition rendering the patient intolerant to revascularisation therapy;
Urinary protein ≥2+;
Contrast medium allergy;
Renal artery anatomy unsuitable for revascularisation therapy;
Parallel
Randomized to stenting
DevicePatients with pharmacologically induced renal FFR ≥ 0.80 will be randomly assigned to receive either stent implantation.
stent implantation
DevicePatients with pharmacologically induced renal FFR \< 0.80 will receive stent implantatio.
Randomized to optimal medical therapy (OMT)
DrugPatients with pharmacologically induced renal FFR ≥ 0.80 will be randomly assigned to optimal medical therapy.
eGFR changes
The change in eGFR(Estimated Glomerular Filtration Rate) at 12 months post-procedure compared to baseline.
24h-SBP changes
24-hour average systolic blood pressure
24h-DBP changes
24-hour average diastolic blood pressure
OBP changes
Change in Office Blood Pressure(OBP) at 12 months post-procedure compared to baseline.
medication load changes
Change in antihypertensive medication load at 12 months post-procedure compared to baseline
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