A randomized, multi-center, prospective study comparing best medical treatment versus best medical treatment plus renal artery stenting in patients with hemodynamically relevant atherosclerotic renal artery stenosis (RADAR) – one-year results of a pre-maturely terminated study | springermedicine.com

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Open Access 01-12-2017 | Research

A randomized, multi-center, prospective study comparing best medical treatment versus best medical treatment plus renal artery stenting in patients with hemodynamically relevant atherosclerotic renal artery stenosis (RADAR) – one-year results of a pre-maturely terminated study

Authors: Thomas Zeller, Hans Krankenberg, Andrejs Erglis, Erwin Blessing, Torsten Fuss, Dierk Scheinert, Ralf Weser, Beatrix B. Doerr, Wilfrid D. Yollo, Joerg Radermacher, for the RADAR Investigators

Published in: Trials | Issue 1/2017

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Abstract

Background

The 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).

Methods

RADAR 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.

Results

Due 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.

Conclusion

In 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 registration

Clinicaltrials.gov, NCT00640406. Registered on 17 March 2008.

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Title: A randomized, multi-center, prospective study comparing best medical treatment versus best medical treatment plus renal artery stenting in patients with hemodynamically relevant atherosclerotic renal artery stenosis (RADAR) – one-year results of a pre-maturely terminated study
Authors: Thomas Zeller
Hans Krankenberg
Andrejs Erglis
Erwin Blessing
Torsten Fuss
Dierk Scheinert
Ralf Weser
Beatrix B. Doerr
Wilfrid D. Yollo
Joerg Radermacher
for the RADAR Investigators
Publication date: 01-12-2017
Publisher: BioMed Central
Published in: Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-017-2126-x

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