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)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Progressive renal function loss (= reduction in estimated Cr clearance by >20%) after 2 yrs follow-up, with an extended follow-up of 5 yrs
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Progressive renal function loss (= reduction in estimated Cr clearance by >20%) after 2 yrs follow-up, with an extended follow-up of 5 yrs
次要结局
- Acute complications
- Late 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
- Cost-effectiveness
- Quality of life