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Stent Placement in Patients With Atherosclerotic Renal Artery Stenosis and Impaired Renal Function
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| 03.07.2009, 19:09 |
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.
Design: 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.
Setting: 10 European medical centers.
Participants: 140 patients with creatinine clearance less than 80
mL/min per 1.73 m 2 and ARAS of 50% or greater.
Intervention: Stent placement and medical treatment (64 patients)
or medical treatment only (76 patients). Medical treatment consisted
of antihypertensive treatment, a statin, and aspirin.
Measurements: 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.
Limitation: Many patients were falsely identified as having renal
artery stenosis greater than 50% by noninvasive imaging and did
not ultimately require stenting.
Conclusion: 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.
Primary Funding Source: Dutch Kidney Foundation, Bayer, Cordis,
and Pfizer.
Ann Intern Med. 2009;150:840-848. www.annals.org
For author affiliations, see end of text.
Clinicaltrials.gov registration number: NCT00150943.
* For a list of investigators, sites, and organization of the STAR (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)
Trial, see the Appendix (available at www.annals.org).
This article was published at www.annals.org on 5 May 2009.
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