The benefit of STent placement and blood pressure and lipid-lowering for the prevention of progression of renal dysfunction caused by Atherosclerotic ostial stenosis of the Renal artery. The STAR-study: rationale and study design.
BACKGROUND
Atherosclerotic renal artery stenosis (ARAS) is associated with progressive loss of renal function and is one of the most important causes of renal failure in the elderly. Current treatment includes restoration of the renal arterial lumen by endovascular stent placement. However, this treatment only affects damage caused by ARAS due to the stenosis and ensuing post-stenotic ischemia. ARAS patients have severe general vascular disease. Atherosclerosis and hypertension can also damage the kidney parenchyma causing renal failure. Medical treatment focuses on the latter. Lipid-lowering drugs (statins) could reduce renal failure progression and could reduce the overall high cardiovascular risk. The additional effect on preserving renal function of stent placement as compared to medical therapy alone is unknown. Therefore, the STAR-study aims to compare the effects of renal artery stent placement together with medication vs. medication alone on renal function in ARAS patients.


METHODS
Patients with an ARAS of > or = 50% and renal failure (creatinine (Cr) clearance < 80 mL/min/1.73 m2) are randomly assigned to stent placement with medication or to medication alone. Medication consists of statins, anti-hypertensive drugs and antiplatelet therapy. Patients are followed for 2 yrs with extended follow-up to 5 yrs. The primary outcome of this study is a reduction in Cr clearance > 20% compared to baseline. This trial will include 140 patients.
Bax
Liesbeth
L
University Medical Centre Utrecht, The Netherlands.
Mali
Willem P Th M
WP
Buskens
Erik
E
Koomans
Hein A
HA
Beutler
J J
JJ
Braam
B
B
Beek
F J A
FJ
Rabelink
T J
TJ
Postma
C T
CT
Huysmans
F T M
FT
Deinum
J
J
Thien
Th
T
Schultze Kool
L J
LJ
Woittiez
A J J
AJ
Kouwenberg
J J
JJ
van den Meiracker
A H
AH
Pattynama
P M T
PM
van de Ven
P J G
PJ
Vroegindeweij
D
D
Doorenbos
C J
CJ
Aarts
J C N M
JC
Kroon
A A
AA
de Leeuw
P W
PW
de Haan
M W
MW
van Engelshoven
J M A
JM
Rutten
M J C M
MJ
van Montfrans
G A
GA
Reekers
J A
JA
Plouin
P F
PF
La Batide Alanore
A
A
Azizi
M
M
Raynaud
A
A
Harden
P N
PN
Cowling
M
M
D000800:Angioplasty, Balloon; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D001161:Arteriosclerosis / Q000150:complications / Q000503:physiopathology / Q000628:therapy*; D000069059:Atorvastatin; D003131:Combined Modality Therapy; D018450:Disease Progression; D006538:Heptanoic Acids / Q000627:therapeutic use*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D007668:Kidney / Q000503:physiopathology; D011758:Pyrroles / Q000627:therapeutic use*; D012077:Renal Artery; D012078:Renal Artery Obstruction / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D012107:Research Design; D015607:Stents
D000959:Antihypertensive Agents; D006538:Heptanoic Acids; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011758:Pyrroles; D000069059:Atorvastatin