Renal Artery Obstruction Clinical Trial
Official title:
Percutaneous Renal Stenting in Renovascular Disease With or Without Distal Atheroembolic Protection
Atherosclerotic renal artery stenosis (ARAS) is associated with progressive loss of renal
function, refractory hypertension and flushing edema, responsible for mortality and
morbidity, especially in the elderly. Current treatment includes restoration of the renal
arterial lumen by endovascular stent placement and/or intensive medical therapy. There is no
unanimous consent on which patients could benefice of the endovascular procedure due to the
high rate of renal adverse events especially linked to atheroembolic disease. Recently,
renal revascularization using a device which consents distal embolic protection of the
kidney demonstrated to be a "safe" auxiliary procedure in a few non randomized studies.
Interestingly atheromatous debris was detected in 60 to 80% of these devices analyzed after
the procedure suggesting that these devices could prevent atheroembolism in a substantial
proportion of patients. On the other hand, only a randomized controlled study can prove that
renal stent with distal embolic protection is superior to renal stent alone in preserving
kidney function.
Therefore, the present study aims to compare the effects of renal artery stent placement
with or without distal embolic protection on renal function in ARAS patients.
Method:
Patients with an ARAS of ≥70% and hypertension not responsive to at least 2 antihypertensive
medications and/or renal failure (estimated GFR <60 mL/min/1.73 m2 are randomly assigned to
stent placement alone or stent placement with distal embolic protection (FILTER WIRE EX;
Cordis Endovascular, USA).
Other medications consist of statins, anti-hypertensive drugs and antiplatelet therapy.
Patients are followed for 3 months. The primary outcome of this study is a statistical
significant difference in kidney function measured as Cr clearance and cystatin C level in
the 2 groups at three months. The trial will include 150 patients.
This is a randomized trial of patients with an ostial ARAS and refractory hypertension and
or renal failure. Patients will be randomized to:
(i) renal artery stent placement with distal embolic protection (ii) renal artery stent
placement without distal embolic protection To both groups an optimal medical treatment
consisting of antihypertensive, lipid-lowering and antiplatelet therapy will be added.
Patients with an ostial ARAS associated with an estimated GFR of <60 mL/min/1.73m2 according
to the MDRD formula and/or refractory hypertension are enrolled in this trial. Ostial ARAS
is defined as a luminal reduction of ≥70% of the renal artery within 1 cm of the aortic
wall, in the presence of atherosclerotic changes of the aorta. Stenosis evaluation can be
performed on intra-arterial angiography.
Medical therapy: Irrespective of baseline serum cholesterol values, the patients will be
treated with lipid-lowering therapy: 10 mg of rosuvastatin. Any lipid-lowering medication
currently used is discontinued and replaced by rosuvastatin. Hypertension is treated with
the following drugs: ACE-inhibitors together, loop diuretic, dihydropyridine calcium
antagonists. The target BP is <140/90 mmHg. Patients will receive anti-platelet therapy,
aspirin 75-100 mg/od plus ticlopidine 250 mg bid for one month. Considering that smoking is
a major renal risk factor, smokers will be advised to stop.
Medical therapy is identical in the two treatment arms. In both groups patients will start
with aspirin 100 mg/od and ticlopidine 250 mg bid at least five days before admission. The
stent (Palmaz-Corinthian IQ/Palmaz Genesis, Johnson & Johnson Medical, NV/SA) will be placed
during an in-patient admission according to a standardized protocol. To Patients randomized
to the embolic protection the device (FILTER WIRE EX; Cordis Endovascular, USA) will be
placed distal to the arterial stenosis before stent placement.
Randomization will be done using random numbers tables The only people aware of the assigned
procedure will be the radiologists' team. Researchers and technicians who will follow the
patients and analyze the plasma and urinary samples will be blinded to the assigned
treatment.
Clinical follow-up is scheduled after 1 and 3 months. Analysis of results: The difference in
the mean change of cystatin C respect to baseline between both treatment arms will be
assessed including 95% confidence intervals (95% CI). The effects on renal function of the
two treatment strategies will be evaluated with multivariate linear regression analysis,
considering also the eventual role of age, smoking, diabetes, lipids level, proteinuria,
bilateral or unilateral renal artery stenosis, BP and renal function at baseline
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
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