Bax, L. et al. Stent placement in patients with atherosclerotic renal artery stenosis and impaired renal function: a randomized trial. Ann. Intern. Med. 150, 840-848

Department of Radiology, University Medical Center Utrecht, Utrecht, the Netherlands.
Annals of internal medicine (Impact Factor: 17.81). 06/2009; 150(12):840-8, W150-1.
Source: PubMed


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.

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    • "The heterogeneity was assessed using I 2 values, and sensitivity analysis was performed to explain the heterogeneity where present. Table 2 Quality assessment of included studies Cooper 2014 ASTRAL 2009 Jaarsveld 2000 Bax 2009 Webster 1998 Plouin 1998 "
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    ABSTRACT: Our aim is to compare the efficacy of revascularization versus medical therapy in patients with Atherosclerotic renal artery stenosis (ARAS). ARAS is the most common cause of secondary hypertension and is associated with several complications such as renal failure, coronary artery disease, cardiac destabilization and stroke. Medical therapy is the cornerstone for management of ARAS; however, numerous trials have compared medical therapy with revascularization in the form of percutaneous transluminal renal angioplasty with or without stenting (PTRA or PTRAS). Medline (PubMed and Ovid SP), Embase ,Cochrane Central Register of Controlled Clinical Trials(CENTRAL) and Cochrane Database of Systematic Review (CDSR) were searched till present (November 2013) to identify clinical trials where medical therapy was compared with revascularization (PTRA or PTRAS). We performed a Meta –analysis using a random effects model. The heterogeneity was assessed using I2 values. The initial database search identified 540 studies and 7 Randomized controlled trials (RCT’s) and 2139 patients were included in the final analysis. Angioplasty with or without stenting was not superior to medical therapy with respect to any outcome. The incidence of non-fatal MI was 6.74% in both the stenting and medical therapy group (OR=0.998, 95% CI: 0.698-1.427, p=0.992) and incidence of renal events in stenting population was found to be 19.58% vs 20.53% in medical therapy (OR=0.945, 95% CI: 0.755-1.182, p=0.620). In conclusion, PTRA or PTRAS does not improve outcomes when compared with medical therapy in ARAS patients. Future studies should investigate to identify patient sub-groups that may benefit from such an intervention.
    The American Journal of Cardiology 10/2014; 114(7). DOI:10.1016/j.amjcard.2014.06.033 · 3.28 Impact Factor
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    • "One large case series reported 30-day mortality after PTRAA of 2.2 % (all deaths occurred in patients with atheromatous disease) [67]. In the 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 (STAR) trial, there were two procedure-related deaths among 46 patients undergoing renal artery stenting [66]. "
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    ABSTRACT: Renal artery stensosis (RAS) continues to be a problem for clinicians, with no clear consensus on how to investigate and assess the clinical significance of stenotic lesions and manage the findings. RAS caused by fibromuscular dysplasia is probably commoner than previously appreciated, should be actively looked for in younger hypertensive patients and can be managed successfully with angioplasty. Atheromatous RAS is associated with increased incidence of cardiovascular events and increased cardiovascular mortality, and is likely to be seen with increasing frequency. Evidence from large clinical trials has led clinicians away from recommending interventional revascularisation towards aggressive medical management. There is now interest in looking more closely at patient selection for intervention, with focus on intervening only in patients with the highest-risk presentations such as flash pulmonary oedema, rapidly declining renal function and severe resistant hypertension. The potential benefits in terms of improving hard cardiovascular outcomes may outweigh the risks of intervention in this group, and further research is needed.
    Current Atherosclerosis Reports 06/2014; 16(6):416. DOI:10.1007/s11883-014-0416-2 · 3.42 Impact Factor
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    • "Another major clinical trial is known as the 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 (STAR) trial.48 STAR was a multicenter randomized study of 140 patients with RAS. "
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    ABSTRACT: Renal artery stenosis (RAS) is a frequently encountered problem in clinical practice. The disease encompasses a broad spectrum of pathophysiologies and is associated with three major clinical syndromes: ischemic nephropathy, hypertension, and destabilizing cardiac syndromes. The two most common etiologies are fibromuscular dysplasia and atherosclerotic renal artery disease with atherosclerotic disease accounting for the vast majority of cases. Atherosclerotic renovascular disease has considerable overlap with atherosclerotic disease elsewhere and is associated with a poor prognosis. A wide range of diagnostic modalities and treatment approaches for RAS are available to clinicians, and with the advent of endovascular interventions, selecting the best course for a given patient has only grown more challenging. Several clinical trials have demonstrated some benefit with revascularization but not to the extent that many had hoped for or expected. Furthermore, much of the existing data is only marginally useful given significant flaws in study design and inherent bias. There remains a need for further identification of subgroups and appropriate indications in hopes of maximizing outcomes and avoiding unnecessary procedures in patients who would not benefit from treatment. In recent decades, the study of RAS has expanded and evolved rapidly. In this review, we will attempt to summarize the amassed body of literature with a focus on the epidemiology of RAS including prevalence, overlap with other atherosclerotic disease, and prognosis. We will also outline existing diagnostic and treatment approaches available to clinicians as well as summarize the findings of several major clinical trials. Finally, we will offer our perspective on future directions in the field.
    International Journal of Nephrology and Renovascular Disease 05/2014; 7:169-181. DOI:10.2147/IJNRD.S40175
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