Abstract
BackgroundThe indications for conservative “best medical treatment” (BMT) versus additional renal artery stenting are a matter of ongoing debate. The RADAR study aimed to evaluate the impact of percutaneous renal artery stenting on the impaired renal function in patients with hemodynamically significant atherosclerotic renal artery stenosis (RAS).MethodsRADAR is an international, prospective, randomized (1:1) controlled study comparing BMT alone versus BMT plus renal artery stenting in patients with duplex sonographic hemodynamically relevant RAS. Follow-up assessments were at 2, 6, and 12 months and at 3 years. The primary endpoint was change in estimated glomerular filtration rate (eGFR) at 12 months.ResultsDue to slow enrollment, RADAR was terminated early after inclusion of 86 of the scheduled 300 patients (28.7%). Change in eGFR between baseline and 12 months was 4.3 ± 15.4 ml/min/1.73 m2 (stent group) and 3.0 ± 14.9 ml/min/1.73 m2 (BMT group), p > 0.999. Clinical event rates were low with a 12-month composite of cardiac death, stroke, myocardial infarction, and hospitalization for congestive heart failure of 2.9% in the stent and 5.3% in the BMT group, p = 0.526, and a 3-year composite of 14.8% and 12.0%, p = 0.982. At 3 years, target vessel (re-)vascularization occurred in one patient (3.0%) in the stent group and in 8 patients (29.4%) in the BMT group.ConclusionIn RADAR, outcomes of renal artery stenting were similar to BMT. These results have to be interpreted with the caveat that the study did not reach its statistically based sample size.Trial registrationClinicaltrials.gov, NCT00640406. Registered on 17 March 2008.
Highlights
The indications for conservative “best medical treatment” (BMT) versus additional renal artery stenting are a matter of ongoing debate
Curing hypertension by means of angioplasty rarely occurs, the number of antihypertensive medications usually can be reduced after successful treatment
While observational cohort studies have shown beneficial effects of stenting compared to BMT, randomized controlled trials (CORAL, ASTRAL, and STAR) have not
Summary
The indications for conservative “best medical treatment” (BMT) versus additional renal artery stenting are a matter of ongoing debate. Atherosclerosis accounts for approximately 90% of cases of renal artery stenosis (RAS). RAS may be treated conservatively with “best medical treatment” (BMT), surgically, or by endovascular interventions using balloon angioplasty and stenting [4]. While observational cohort studies have shown beneficial effects of stenting compared to BMT, randomized controlled trials (CORAL, ASTRAL, and STAR) have not. The outcomes in the latter were due to overly liberal inclusion criteria, e.g. inclusion of hemodynamically insignificant lesions with a stenosis diameter < 70% [4, 5]
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