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Titolo Stent Placement in Patients With Atherosclerotic Renal Artery Stenosis and Impaired Renal Function - A Randomized Trial
Autore Liesbeth Bax, MD, PhD; Arend-Jan J. Woittiez, MD, PhD; Hans J. Kouwenberg, MD; Willem P.T.M. Mali, MD, hD; 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-Franc¬łois 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; and Jaap J. Beutler, MD, PhD*
Referenza Annals of Internal Medicine 2009; 150: 840-848
Contenuto 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.
Data 18.06.2009
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