Stent Placement in Patients With Atherosclerotic Renal Artery Stenosis and Impaired Renal Function: A Randomized Trial.
Bax, Liesbeth MD, PhD; Woittiez, Arend-Jan J. MD, PhD; Kouwenberg, Hans J. MD; Mali, Willem P.T.M. MD, PhD; Buskens, Erik MD, PhD; Beek, Frederik J.A. MD, PhD; Braam, Branko MD, PhD; Huysmans, Frans T.M. MD, PhD; Schultze Kool, Leo J. MD, PhD; Rutten, Matthieu J.C.M. MD; Doorenbos, Cornelius J. MD, PhD; Aarts, Johannes C.N.M. MD; Rabelink, Ton J. MD, PhD; Plouin, Pierre-Francois MD; Raynaud, Alain MD; van Montfrans, Gert A. MD, PhD; Reekers, Jim A. MD, PhD; van den Meiracker, Anton H. MD, PhD; Pattynama, Peter M.T. MD, PhD; van de Ven, Peter J.G. MD, PhD; Vroegindeweij, Dammis MD, PhD; Kroon, Abraham A. MD, PhD; de Haan, Michiel W. MD, PhD; Postma, Cornelis T. MD, PhD; Beutler, Jaap J. MD, PhD *
[Article] Annals of Internal Medicine. 150(12):840-848, June 16, 2009.

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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 m2 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.

(C) 2009 American College of Physicians