Stent placement in patients with atherosclerotic renal artery stenosis and impaired renal function: a randomized trial.

Department of Radiology, University Medical Center Utrecht, Utrecht, the Netherlands.
Annals of internal medicine (Impact Factor: 16.1). 06/2009; 150(12):840-8, W150-1.
Source: PubMed

ABSTRACT 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 m(2) 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.

  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: The Safety and Effectiveness Study of the Herculink Elite Renal Stent to Treat Renal Artery Stenosis (HERCULES) trial is a prospective, multicenter trial evaluating the safety, effectiveness, and durability of the RX Herculink Elite renal stent system (Abbott Vascular, Abbott Park, IL) in select patients with atherosclerotic renal artery stenosis and uncontrolled hypertension. A total of 202 patients were enrolled between August 2007 and October 2009. The primary endpoint, 9-month binary restenosis, was 10.5% determined by core laboratory adjudicated duplex ultrasound and/or angiography. Additional analyses included changes in blood pressure, antihypertensive medications, renal function (RF), major adverse events (MAEs) (death, ipsilateral nephrectomy, and embolic events resulting in kidney damage), and clinically driven target lesion revascularization (CD-TLR) between baseline and 36 months. Freedom from MAE was 98.5% at 30 days. At 36 months, freedom from death, nephrectomy, and CD-TLR were 90.1%, 100%, and 91.8%, respectively. After 30 days there were no site-reported embolic events resulting in kidney damage. The mean baseline systolic blood pressure of 162±18 mm Hg significantly decreased postprocedure and through 36 months (mean systolic blood pressure 141 mm Hg [P<.0001] and 146 mm Hg [P<.0001], respectively). No differences were noted in antihypertensive medications or RF compared with baseline. The HERCULES trial demonstrated sustained clinically and statistically significant reduction in SBP in patients with uncontrolled HTN. Coupled with the low core laboratory-adjudicated in-stent restenosis, acceptable procedural complication rates (1.5%), and <10% CD-TLR, the study suggests that there may be a role for renal artery stenting using contemporary stent technology.
    Journal of Clinical Hypertension 06/2014; 16(7). DOI:10.1111/jch.12341 · 2.96 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Interventional radiologic procedures offer a significant and expanding role in the management of various renovascular diseases including renal artery stenosis, renal artery aneurysm and pseudoaneurysm, renal vascular malformations, renal tumours, trauma, and resistant hypertension. In this article, we discuss these entities in the context of currently accepted definitions, incidence, modes of diagnosis, and management as they pertain to the practice of interventional radiology. Particular emphasis is placed on current interventional procedures for managing and treating these diseases as well as emerging procedures and technologies.
    10/2014; DOI:10.1007/s13244-014-0363-z
  • Complicaciones de los procedimientos endovasculares, Procivas S.L.N.E. edited by Carlos Vaquero Puerta, 04/2014: chapter Complicaciones del tratamiento endovascular de la patología de la arteria renal: pages 221-228; , ISBN: 978-84-617-0292-3

Full-text (2 Sources)

Available from
Jul 10, 2014