Stenting in Renal Dysfunction Caused by Atherosclerotic Renal Artery Stenosis

April 26, 2006 updated by: UMC Utrecht

The Benefit of 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)

Background:

Atherosclerotic renal artery stenosis (ARAS) is associated with progressive loss of renal function and is one of the most important causes of renal failure in the elderly. Current treatment includes restoration of the renal arterial lumen by endovascular stent placement. However, this treatment only affects damage caused by ARAS due to the stenosis and ensuing post-stenotic ischemia. ARAS patients have severe general vascular disease. Atherosclerosis and hypertension can also damage the kidney parenchyma causing renal failure. Medical treatment focuses on the latter. Lipidlowering drugs (statins) could reduce renal failure progression and could reduce the overall high cardiovascular risk. The additional effect on preserving renal function of stent placement as compared to medical therapy alone is unknown. Therefore, the STAR-study aims to compare the effects of renal artery stent placement together with medication vs. medication alone on renal function in ARAS patients.

Method:

Patients with an ARAS of ≥50% and renal failure (creatinine (Cr) clearance <80 mL/min/1.73 m2) are randomly assigned to stent placement with medication or to medication alone. Medication consists of statins, anti-hypertensive drugs and antiplatelet therapy. Patients are followed for 2 yrs with extended follow-up to 5 yrs. The primary outcome of this study is a reduction in Cr clearance >20% compared to baseline. This trial will include 140 patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, multicenter trial of patients with an ostial ARAS and renal failure. Patients will be randomized to:

(i)medical treatment consisting of antihypertensive, lipid-lowering and antiplatelet therapy plus the advice to stop smoking; or (ii)medical treatment as outlined in (i) with additional stent placement.

Patients with an ostial ARAS, a Cr clearance of <80 mL/min/1.73m2 according to the Cockcroft and Gault formula and stable blood pressure (BP) control are enrolled in this trial. Ostial ARAS is defined as a luminal reduction of ≥50% of the renal artery within 1 cm of the aortic wall, in the presence of atherosclerotic changes of the aorta. Stenosis evaluation can be performed on CT-angiography, MR angiography or intra-arterial angiography.

Medical therapy: Irrespective of baseline serum cholesterol values, the patients will be treated with lipid-lowering therapy: 10 mg of atorvastatin and if this is well tolerated the dose will be doubled to the final dose of 20 mg. Any lipid-lowering medication currently used is discontinued and replaced by atorvastatin. Hypertension is treated with the following drugs: thiazide diuretic, calcium antagonist, beta-blocker and alpha-blocker. ACE-inhibitors/angiotensin-II-antagonists together with increasing loop diuretic doses, should be used only as a last resort antihypertensive treatment when other classes of antihypertensive agents have failed. The target BP is <140/90 mmHg. Patients will receive anti-platelet therapy, aspirin 75-100 mg/od. Considering that smoking is a major renal risk factor, smokers will be advised to stop.

Stent and medical therapy: Medical therapy is identical in the two treatment arms. In the stent group, patients will start with aspirin 75-100 mg/od the day before admission. The stent (Palmaz-Corinthian IQ/Palmaz Genesis, Johnson & Johnson Medical, NV/SA) will be placed during an in-patient admission according to a standardized protocol.

Randomisation will be done per participating centre and will be stratified for unilateral or bilateral abnormalities. An unilateral abnormality is defined as an unilateral ostial stenosis and on the other side a normal renal artery or a truncal stenosis (a truncal stenosis is nearly always easy to dilate by angioplasty). All other patients are considered to have bilateral abnormalities

Clinical follow-up is scheduled after 1, 3 and then every 3 months for the first 2 yrs and every 6 months until the 5 yr follow-up is completed. Economic data are assessed after 3 mths and every 3 mths for 2 yrs. Quality of life will be measured by standardized SF-36 and EQ-5D health questionnaires before, after 1 mth and every 6 mths for 2 yrs.

Indications for stent placement in the medically treated patients and re-angiography and balloon dilatation of the stent in the stented patients are: (i) a persistent >20% reduction of Cr clearance; (ii) therapy refractory hypertension (defined as an office BP >180/100 mmHg during three follow-up visits and subsequently a mean daily BP of >160/95 mmHg on 24 hr ambulant BP monitoring, while on the maximum dose of all classes of antihypertensives); (iii) pulmonary edema in the presence of bilateral renovascular disease and a normal or slightly impaired left ventricular function on echocardiography in combination with ACE-inhibitors/angiotensin-II antagonist intolerance defined as a fall of estimated Cr clearance by >20% and; (iv) malignant hypertension (defined as fundus grade III/IV).

Analysis of results: The difference in the proportion of patients with progressive renal dysfunction between both treatment arms will be assessed including 95% confidence intervals (95% CI). Mean change and difference in renal function change, including 95% CI will be reported. With multivariate logistic regression analysis not only will the effects of the two treatment strategies be evaluated, but also whether there are independent effects of age, smoking, proteinuria, bilateral or unilateral renal artery stenosis, BP and renal function at baseline.

Study Type

Interventional

Enrollment

140

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • UMC Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >18 years
  • Ostial atherosclerotic renal artery stenosis ≥50% on CTA, MRA or intra-arterial angiography
  • Estimated creatinine clearance <80 ml/min/1.73m2 according to the Cockcroft and Gault formula, on two occasions within one month

Exclusion Criteria:

  • Declined informed consent
  • Proven cholesterol embolisation at previous interventions
  • Renal artery diameter <4mm
  • Estimated creatinine-clearance <15ml/min/1.73m2
  • Diabetes Mellitus with proteinuria >3g/24h
  • Any known cause of renal failure other than ischemic nephropathy
  • Pulmonary oedema in the presence of bilateral renovascular disease in combination with intolerance of ACE-inhibitors/ Angiotensin-II antagonists defined as a fall of estimated creatinine clearance of >20%
  • Malignant hypertension (fundus grade III/IV)
  • Myocardial infarction or CVA <3 months before planned date of inclusion
  • Contra-indication for the use of atorvastatin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Progressive renal function loss (= reduction in estimated Cr clearance by >20%) after 2 yrs follow-up, with an extended follow-up of 5 yrs

Secondary Outcome Measures

Outcome Measure
Quality of life
Cost-effectiveness
Late complications
Acute complications
Occlusion of the stenotic renal artery
Incidence and time to doubling of serum Cr
Initiation of dialysis therapy
Effect on hypertension and the occurrence of therapy refractory or malignant hypertension
Incidence of pulmonary edema
Cardiovascular morbidity and mortality
Total mortality

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Investigators

  • Principal Investigator: Jaap J. Beutler, MD.PhD, UMC Utrecht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (ESTIMATE)

September 8, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

April 27, 2006

Last Update Submitted That Met QC Criteria

April 26, 2006

Last Verified

April 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C99.1810-STAR
  • C99.1810

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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