Stent placement in patients with atherosclerotic renal artery stenosis and impaired renal function: a randomized trial.
BACKGROUND
Little is known about the efficacy and safety of renal artery stenting in patients with atherosclerotic renal artery stenosis (ARAS) and impaired renal function.


OBJECTIVE
To determine the efficacy and safety of stent placement in patients with ARAS and impaired renal function.


METHODS
Randomized clinical trial. Randomization was centralized and computer generated, and allocation was assigned by e-mail. Patients, providers, and persons who assessed outcomes were not blinded to treatment assignment.


METHODS
10 European medical centers.


METHODS
140 patients with creatinine clearance less than 80 mL/min per 1.73 m(2) and ARAS of 50% or greater.


METHODS
Stent placement and medical treatment (64 patients) or medical treatment only (76 patients). Medical treatment consisted of antihypertensive treatment, a statin, and aspirin.


METHODS
The primary end point was a 20% or greater decrease in creatinine clearance. Secondary end points included safety and cardiovascular morbidity and mortality.


RESULTS
Forty-six of 64 patients assigned to stent placement had the procedure. Ten of the 64 patients (16%) in the stent placement group and 16 patients (22%) in the medication group reached the primary end point (hazard ratio, 0.73 [95% CI, 0.33 to 1.61]). Serious complications occurred in the stent group, including 2 procedure-related deaths (3%), 1 late death secondary to an infected hematoma, and 1 patient who required dialysis secondary to cholesterol embolism. The groups did not differ for other secondary end points.


CONCLUSIONS
Many patients were falsely identified as having renal artery stenosis greater than 50% by noninvasive imaging and did not ultimately require stenting.


CONCLUSIONS
Stent placement with medical treatment had no clear effect on progression of impaired renal function but led to a small number of significant procedure-related complications. The study findings favor a conservative approach to patients with ARAS, focused on cardiovascular risk factor management and avoiding stenting.
Department of Radiology, University Medical Center Utrecht, Utrecht, the Netherlands.
Liesbeth
L
Bax
Arend-Jan J
AJ
Woittiez
Hans J
HJ
Kouwenberg
Willem P T M
WP
Mali
Erik
E
Buskens
Frederik J A
FJ
Beek
Branko
B
Braam
Frans T M
FT
Huysmans
Leo J
LJ
Schultze Kool
Matthieu J C M
MJ
Rutten
Cornelius J
CJ
Doorenbos
Johannes C N M
JC
Aarts
Ton J
TJ
Rabelink
Pierre-François
PF
Plouin
Alain
A
Raynaud
Gert A
GA
van Montfrans
Jim A
JA
Reekers
Anton H
AH
van den Meiracker
Peter M T
PM
Pattynama
Peter J G
PJ
van de Ven
Dammis
D
Vroegindeweij
Abraham A
AA
Kroon
Michiel W
MW
de Haan
Cornelis T
CT
Postma
Jaap J
JJ
Beutler
D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use; D001241:Aspirin / Q000627:therapeutic use; D050197:Atherosclerosis / Q000150:complications*; D000069059:Atorvastatin; D003131:Combined Modality Therapy; D005260:Female; D006538:Heptanoic Acids / Q000627:therapeutic use; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use; D007668:Kidney / Q000503:physiopathology*; D008297:Male; D008875:Middle Aged; D011758:Pyrroles / Q000627:therapeutic use; D012077:Renal Artery; D012078:Renal Artery Obstruction / Q000209:etiology / Q000503:physiopathology* / Q000628:therapy*; D015607:Stents / Q000009:adverse effects
D000959:Antihypertensive Agents; D006538:Heptanoic Acids; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011758:Pyrroles; D000069059:Atorvastatin; D001241:Aspirin