Liesbeth Bax, MD, PhD; Arend-Jan J. Woittiez, MD, PhD; Hans J. Kouwenberg, MD; Willem P.T.M. Mali, MD, PhD; Erik Buskens, MD, PhD; Frederik J.A. Beek, MD, PhD; Branko Braam, MD, PhD; Frans T.M. Huysmans, MD, PhD; Leo J. Schultze Kool, MD, PhD; Matthieu J.C.M. Rutten, MD; Cornelius J. Doorenbos, MD, PhD; Johannes C.N.M. Aarts, MD; Ton J. Rabelink, MD, PhD; Pierre-François Plouin, MD; Alain Raynaud, MD; Gert A. van Montfrans, MD, PhD; Jim A. Reekers, MD, PhD; Anton H. van den Meiracker, MD, PhD; Peter M.T. Pattynama, MD, PhD; Peter J.G. van de Ven, MD, PhD; Dammis Vroegindeweij, MD, PhD; Abraham A. Kroon, MD, PhD; Michiel W. de Haan, MD, PhD; Cornelis T. Postma, MD, PhD; Jaap J. Beutler, MD, PhD
Bax L, Woittiez AJ, Kouwenberg HJ, Mali WP, Buskens E, Beek FJ, et al. Stent Placement in Patients With Atherosclerotic Renal Artery Stenosis and Impaired Renal Function: A Randomized Trial. Ann Intern Med. 2009;150:840-848. doi: 10.7326/0003-4819-150-12-200906160-00119
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Published: Ann Intern Med. 2009;150(12):840-848.
Little is known about the efficacy and safety of renal artery stenting in patients with atherosclerotic renal artery stenosis (ARAS) and impaired renal function.
To determine the efficacy and safety of stent placement in patients with ARAS and impaired renal function.
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.
10 European medical centers.
140 patients with creatinine clearance less than 80 mL/min per 1.73 m2 and ARAS of 50% or greater.
Stent placement and medical treatment (64 patients) or medical treatment only (76 patients). Medical treatment consisted of antihypertensive treatment, a statin, and aspirin.
The primary end point was a 20% or greater decrease in creatinine clearance. Secondary end points included safety and cardiovascular morbidity and mortality.
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.
Many patients were falsely identified as having renal artery stenosis greater than 50% by noninvasive imaging and did not ultimately require stenting.
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.
Dutch Kidney Foundation, Bayer, Cordis, and Pfizer.
Renal stents are commonly used to treat renal artery stenosis.
In this randomized trial, medical treatment of renal artery stenosis was compared with medical treatment plus stenting. Patients who underwent stenting experienced no clear benefits, and several experienced complications, including 2 procedure-related deaths.
The study was underpowered to provide a definitive estimate of efficacy.
In this sample, stenting of stenosed renal arteries provided no clear benefit and caused harm, suggesting that patients with renal artery stenosis should be treated with medical therapy alone.
* Included in analysis.
The analysis was censored by death and loss to follow-up.
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