Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients.

Inclusion Criteria:

1. One or more severe atherosclerotic renal artery stenoses defined as a stenosis ≥70% bycatheter-based angiography.
2. In addition, at least one of the following high-risk clinical syndromes:
3. Resistant hypertension with average 24-hour ambulatory systolic blood pressure ≥150 mmHg despite ≥3 antihypertensive drugs including a diuretic, if tolerated,and each prescribed at optimal doses.
4. Rapidly declining kidney function with a reduction in estimated GFR of >5 mL/minper 1.73m2 per year and average 24-hour ambulatory systolic blood pressure ≥140mmHg despite ≥3 antihypertensive drugs including a diuretic, if tolerated, andeach prescribed at optimal doses.
5. Hospital admissions with acute decompensated heart failure (≥2 hospitalizationsfor heart failure or ≥1 hospitalizations for sudden, "flash" pulmonary edema)with no obvious explanations such as nonadherence, left ventricular ejectionfraction <40%, or valvular heart disease and average 24-hour ambulatory systolicblood pressure ≥140 mmHg despite ≥3 antihypertensive drugs including a diuretic,if tolerated, and each prescribed at optimal doses. All 24-hour ambulatory blood pressure monitorings are performed after nurse-administeredmedication.

Exclusion Criteria:

• Unable to provide informed consent.
• Treatment resistant heart failure episodes presumed caused by renovascular disease.
• Rapidly declining kidney function/acute kidney failure approaching the need fordialysis presumed caused by renovascular disease.
• Fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis known to bepresent prior to randomization.
• Pregnancy or unknown pregnancy status in female of childbearing potential.
• Kidney size <7 cm (pole to pole length) supplied by target vessel.
• Previous kidney transplant.
• Previous PTRA treatment.
• Presence of a renal artery stenosis not amenable for treatment with a stent. Patients who are not eligible for randomization but treated with renal artery stentingoutside the protocol are followed according to the DAN-PTRAII protocol in order to accountfor all PTRA treatments performed in Denmark in the study period. Patients treated with renal artery stenting without randomization in the study periodinclude patients with:

1. Treatment resistant heart failure episodes presumed caused by renovascular disease.
2. Rapidly declining kidney function/acute kidney failure approaching the need fordialysis presumed caused by renovascular disease.
3. At least one of the listed high-risk clinical syndromes AND one or more significantatherosclerotic renal artery stenoses defined as a stenosis of 50-69% bycatheter-based angiography with:

• a mean translesional gradient of ≥10 mm Hg, or
• a systolic translesional gradient of ≥20 mm Hg, or
• a renal fractional flow reserve (Pd/Pa) of ≤0.8