Aims: To evaluate the technical performance of a dedicated renal stent device and the clinical outcome.
Methods and results: Fifty patients with 55 renal artery stenoses (RAS) >70% (66 +/- 12 years, 58% male) were included in this non-randomised, prospective, multicentre registry. Primary endpoint was the primary patency rate at one year defined as > or =70% as determined by duplex ultrasound. Major secondary endpoints were procedural success, 30 days MACE rate, the impact of the intervention on renal function, blood pressure control, and on B-type natriuretic peptide (BNP) level. Procedural success rate was 100% and 30 days MACE rate was 0%. Restenosis rate (primary endpoint) and target lesion revascularisation rate after 12 months were 3.5% and 1.8%, respectively. After one year estimated glomerular filtration rate increased from 51 +/- 26 ml/min to 61 +/- 28 ml/min (P=0.004). Mean ambulatory blood pressure was reduced from 102 +/- 14 mmHg to 93 +/- 9 mmHg (P=0.001). Mean daily dose of antihypertensive drugs decreased from 3.0 +/- 1.7 to 2.7 +/- 1.4 (P=0.09). Mean BNP decreased from 251 +/- 282 pg/ml to 188 +/- 219 pg/ml (P=0.046) before discharge.
Conclusions: Technical outcome of the tested device is favourable. The impact of the stent revascularisation on renal function and blood pressure control was promising.