RADAR – A randomised, multi-centre, prospective study comparing best medical treatment versus best medical treatment plus renal artery stenting in patients with haemodynamically relevant atherosclerotic renal artery stenosis

<p>Abstract</p> <p>Background</p> <p>Prospective, international, multi-centre, randomised (1:1) trial to evaluate the clinical impact of percutaneous transluminal renal artery stenting (PTRAS) on the impaired renal function measured by the estimated glomerular filtration rate (eGFR) in patients with haemodynamically significant atherosclerotic renal artery stenosis.</p> <p>Methods</p> <p>Patients will be randomised to receive either PTRAS using the Dynamic Renal Stent system plus best medical treatment or best medical treatment. Renal stenting will be performed under angiographic imaging. For patients randomised to best medical treatment the degree of stenosis measured by renal duplex sonography (RDS) will be confirmed by MR angio or multi-slice CT where possible. Best medical treatment will be initiated at randomisation or post procedure (for PTRAS arm only), and adjusted as needed at all visits. Best medical treatment is defined as optimal drug therapy for control of the major risk factors (blood pressure ≤ 125/80 mmHg, LDL cholesterol ≤ 100 mg/dL, HbA1c ≤ 6.5%). Data recordings include serum creatinine values, eGFR, brain natriuretic peptide, patients' medical history and concomitant medication, clinical events, quality of life questionnaire (SF-12v2™), 24 hour ambulatory blood pressure measurement, renal artery duplex ultrasound and echocardiography. Follow-up intervals are at 2, 6, 12 and 36 months following randomisation.</p> <p>The primary endpoint is the difference between treatments in change of eGFR over 12 months. Major secondary endpoints are technical success, change of renal function based on the eGFR slope change between pre-treatment and post-treatment (i.e. improvement, stabilisation, failure), clinical events overall such as renal or cardiac death, stroke, myocardial infarction, hospitalisation for congestive heart failure, progressive renal insufficiency (i.e. need for dialysis), need of target vessel revascularisation or target lesion revascularisation, change in average systolic and diastolic blood pressure, change in left ventricular mass index calculated from echocardiography, difference in the size of kidney (pole to pole length) measured by renal duplex sonography, total number, drug name, drug class, daily dose, regimen and Defined Daily Dose (DDD), of anti-hypertensive drugs, and change in New York Heart Association (NYHA) classification. Approximately 30 centres in Europe and South America will enrol patients. Duration of enrolment is expected to be 12 months resulting in study duration of 48 months.</p> <p>Trial registration</p> <p><b>Trial registration number</b>: NCT00640406</p

Improved renal function and blood pressure control following renal artery angioplasty : the renal artery angioplasty in patients with renal insufficiency and hypertension using a dedicated renal stent device study (PRECISION)

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

Sirolimus-Eluting Stents for Treatment of Infrapopliteal Arteries Reduce Clinical Event Rate Compared to Bare-Metal Stents Long-Term Results From a Randomized Trial

ObjectivesThe study investigated the long-term clinical impact of sirolimus-eluting stents (SES) in comparison with bare-metal stents (BMS) in treatment of focal infrapopliteal lesions.BackgroundThere is evidence that SES reduce the risk of restenosis after percutaneous infrapopliteal artery revascularization. No data from randomized trials are available concerning the clinical impact of this finding during long-term follow-up.MethodsThe study extended the follow-up period of a prospective, randomized, multicenter, double-blind trial comparing polymer-free SES with placebo-coated BMS in the treatment of focal infrapopliteal de novo lesions. The main study endpoint was the event-free survival rate defined as freedom from target limb amputation, target vessel revascularization, myocardial infarction, and death. Secondary endpoints include amputation rates, target vessel revascularization, and changes in Rutherford-Becker class.ResultsThe trial included 161 patients. The mean target lesion length was 31 ± 9 mm. Thirty-five (23.3%) patients died during a mean follow-up period of 1,016 ± 132 days. The event-free survival rate was 65.8% in the SES group and 44.6% in the BMS group (log-rank p = 0.02). Amputation rates were 2.6% and 12.2% (p = 0.03), and target vessel revascularization rates were 9.2% and 20% (p = 0.06), respectively. The median (interquartile range) improvement in Rutherford-Becker class was –2 (–3 to –1) in the SES group and –1 (–2 to 0) in the BMS group, respectively (p = 0.006).ConclusionsLong-term event-free survival, amputation rates, and changes in Rutherford-Becker class after treatment of focal infrapopliteal lesions are significantly improved with SES in comparison with BMS. (YUKON-Drug-Eluting Stent Below the Knee - Randomised Double-Blind Study [YUKON-BTX]; NCT00664963