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.
Subject(s)
Angioplasty, Balloon/instrumentation , Antihypertensive Agents/therapeutic use , Atherosclerosis/therapy , Early Termination of Clinical Trials , Hemodynamics/drug effects , Hypertension, Renovascular/therapy , Renal Artery Obstruction/therapy , Stents , Adult , Aged , Aged, 80 and over , Angioplasty, Balloon/adverse effects , Angioplasty, Balloon/mortality , Antihypertensive Agents/adverse effects , Atherosclerosis/diagnostic imaging , Atherosclerosis/mortality , Atherosclerosis/physiopathology , Brazil , Europe , Female , Glomerular Filtration Rate/drug effects , Humans , Hypertension, Renovascular/diagnostic imaging , Hypertension, Renovascular/mortality , Hypertension, Renovascular/physiopathology , Male , Middle Aged , Patient Selection , Prospective Studies , Renal Artery Obstruction/diagnostic imaging , Renal Artery Obstruction/mortality , Renal Artery Obstruction/physiopathology , Sample Size , Time Factors , Treatment Outcome , Ultrasonography, Doppler, DuplexABSTRACT
The prevalence of peripheral artery disease (PAD) is continuously increasing. In addition, the treatment of PAD has changed substantially over the last decades. Novel treatment modalities and diagnostic tools were developed and endovascular therapy was established as a first-line therapy. In consequence, vascular medicine has become an interdisciplinary field, involving different specialties such as internal medicine/cardiology, internal medicine/angiology, vascular surgery, and (interventional) radiology. Attributed to the expanding field and to ensure high quality and standardized training, various curricula were developed. Not only within the different medical disciplines but across countries. We compared the training programmes in Germany, Switzerland, and Europe and found a great variety in these curricula and programmes. Nevertheless, we identified first attempts to harmonize training requirements within the various societies: the interdisciplinary guidelines of the German Society for Cardiology (DGK) and the German Society of Angiology, the adoption of European standards on a national level, and the Swiss initiative of the Union of Vascular Societies of Switzerland (UVSS). The standard and level of training is high in all curricula and societies. However, further harmonization is needed to optimize patient care and ensure a uniform quality level across different vascular societies.
