Renal Artery Stenting in Patients With Documented Resistant Hypertension and Atherosclerotic Renal Artery Stenosis (ANDORRA)
Renal Artery Stenting in Patients With Documented Resistant Hypertension and Atherosclerotic Renal Artery Stenosis (ANDORRA)
The ANDORRA study is a, multicenter, prospective, open, randomized, controlled blinded
 endpoint trial (PROBE) comparing two treatment strategies (renal artery stenting +
 standardized and optimized medical treatment [SOMT] versus SOMT alone) of 12 months duration
 in patients with confirmed resistant hypertension (RH) and angiographically proven grade III
 unilateral or bilateral atherosclerotic renal artery stenosis (ARAS) ≥ 60%.
All eligible patients diagnosed with RH on office BP measurements and unilateral or bilateral
 ARAS ≥60% on a non-invasive test (CT-angiogram or MR-angiogram) will receive a standardized
 optimized triple antihypertensive treatment for 4 weeks. After 4 weeks, patients with
 confirmed RH by ABPM (daytime ABPM ≥ 135 or 85 mmHg) and no clinically significant increase
 in plasma creatinine from baseline (< 30%) will undergo a renal angiogram to confirm the
 degree of ARAS ≥60% in diameter.

 Immediately after the renal angiography, all patients will undergo flow fractional reserve
 (FFR) measurements. Once FFR measurements have been done and all criteria are met, patients
 will be randomized in the angiography room to either renal artery stenting + SOMT (stenting
 group) versus SOMT (control group) whatever the results of the FFR in a 1:1 ratio. Both
 groups will continue the SOMT during follow-up.

 The SOMT will be prescribed from the inclusion visit until the 6 month-visit after
 randomization. After randomization, the antihypertensive treatment will be adapted according
 to the results of home BP (HBP) at monthly visits starting 2 months after randomization.
 After the 6-month visit, the antihypertensive treatment adaptation will be left at the
 discretion of the physician in charge of the patient.
Inclusion Criteria:

 -  Age: 40 to 80 Years

 -  Men or women

 -  Supine office BP ≥ 140 and/or 90 mmHg at screening despite a stable medication regimen
 including full tolerated doses of 3 or more anti-hypertensive treatments of different
 classes, including a diuretic.

 -  Unilateral or bilateral ARAS of a main renal artery ≥60% diagnosed by renal CT-
 angiogram (or MR-angiogram if there is a contraindication to perform CT) performed in
 the year before

 -  One or two functional kidney(s) ≥ 70 mm in pole-to-pole length

 -  eGFR ≥ 20 ml/min/1.73 m² (MDRD formula)

 -  Signed informed consent

 -  Social insurance coverage

 Inclusion criteria for the renal angiogram procedure:

 - RH confirmed by daytime ABPM ≥ 135 or 85 mmHg after 1 month treatment with SOMT at Visit
 V1.

 Inclusion criteria for the randomization:

 -  Unilateral or bilateral ARAS of a main renal artery ≥ 60% confirmed on renal angiogram
 by Quantitative Vascular Analysis (QVA)

 -  Increase in plasma creatinine < 30% after 4-week SOMT

 Exclusion Criteria:

 -  Fibromuscular dysplasia of renal artery or other non-atherosclerotic renal artery
 stenosis

 -  Other secondary form of hypertension excluded on the basis of a clinical,
 hormonological and/or imaging work-up

 -  Restenosis after a previous renal angioplasty or stenting

 -  Only a stenosis of an accessory renal artery supplying <1/2 of the ipsilateral renal
 parenchyma

 -  Additional indication of ARAS stenting (Malignant hypertension, ≥ 30% increase in
 plasma creatinine after renin angiotensin system (RAS) blocker or after RAS blocker
 and diuretic administration, flash pulmonary edema)

 -  Kidney pole-to-pole length < 70 mm

 -  Vascular disease precluding access for stenting

 -  Abrupt vessel closure or dissection after diagnostic angiography

 -  Contraindication to renal artery stenting according the notice for use of the stents

 -  eGFR < 20 ml/min/1.73 m² (MDRD)

 -  History of transient ischemic accident (TIA) or cerebrovascular accident (CVA) during
 the 3 months prior to visit 1

 -  History of acute heart failure or heart failure (NYHA class III-IV) within the 3
 months prior to visit 1

 -  History of myocardial infarction, unstable angina, coronary bypass or percutaneous
 coronary angioplasty during the 3 months prior to visit 1

 -  Abdominal aortic aneurysm with indication for surgery or EVAR (Endovascular Aneurysm
 Repair)

 -  Known history of cholesterol embolism

 -  Brachial circumference of ≥ 42 cm

 -  Severe contrast media allergy, not amenable to pre-treatment

 -  Allergy to aspirin or clopidogrel

 -  Atrial fibrillation

 -  Comorbid condition causing life expectancy ≤ 3 years

 -  Unlikely to co-operate in the study and/or poor compliance anticipated by the
 investigator

 -  Participant not affiliated to the French social security

 -  Pregnancy or breastfeeding

 -  Guardianship for incapacity