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.

BACKGROUND: 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. METHODS: 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 < or = 125/80 mmHg, LDL cholesterol < or = 100 mg/dL, HbA1c < or = 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.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. TRIAL REGISTRATION NUMBER: NCT00640406.

Results after balloon angioplasty or stenting of atherosclerotic subclavian artery obstruction.

INTRODUCTION: Endovascular therapy is an accepted treatment strategy in occlusive disease of the subclavian artery. The purpose of this study was to evaluate the technical and clinical long-term outcome following either balloon angioplasty (plain balloon angioplasty (PTA)) or stenting. PATIENTS AND METHODS: The authors retrospectively analyzed 108 interventions of atherosclerotic lesions of subclavian arteries or the brachiocephalic trunk (107 patients; mean age of 66 +/- 9 years; 90% symptomatic) representing 92% of the patients treated with subclavian artery obstructive disease during a 10-year period. Primary endpoint of the study was the 1-year primary patency rate. Follow-up was based on oscillometry, Doppler blood pressure measurements, and duplex ultrasound. RESULTS: The primary success rate was 97% (100% for stenoses (78/78) and 87% for total occlusions (26/30)). Treatment modalities included PTA alone (13%; n = 14) or stenting (87%; n = 90) with balloon-expandable (n = 61), self-expanding (n = 17), or both types of devices (n = 12). The 1-year primary patency rate of the 97 patients eligible for follow-up was 88%, for the subgroups 79% (PTA) and 89% (stenting; P = 0.2). The blood pressure difference between both limbs at baseline was 45 +/- 26 mm Hg and dropped to 10 +/- 14 mm Hg (P < 0.001) after the intervention and 15 +/- 19 mm Hg at 1 year (P < 0.01). CONCLUSION: Endovascular therapy of atherosclerotic subclavian artery obstructions result in excellent acute success rates even in total occlusions. Results evince good durability of endovascular therapy for atherosclerotic occlusive disease of subclavian arteries and with a trend towards better outcome with stenting compared to PTA.

Acute and long-term outcome of endovascular therapy for aortoiliac occlusive lesions stratified according to the TASC classification: a single-center experience.

PURPOSE: To compare acute and long-term outcomes of endovascular therapy for TASC (TransAtlantic Inter-Society Consensus) A and B lesions versus TASC C and D lesions. METHODS: Based on a prospectively maintained database, a retrospective analysis was conducted of 375 symptomatic patients (335 men; mean age 63+/-8 years) who underwent 438 interventions for aortoiliac arterial obstructions. Lesions were stratified according to the TASC II classification: 259 (59%) procedures involved TASC A/B lesions, while 113 (26%) were for TASC C and 66 (15%) for TASC D lesions. RESULTS: The baseline characteristics of patients with TASC A/B lesions differed significantly in the ankle-brachial index (ABI), occurrence of renal insufficiency, and lesion characteristics from those with TASC C or D lesions. Acute treatment success, defined as residual stenosis <30%, was 100%, 96%, 93%, and 100% for TASC A, B, C, and D lesions, respectively. The primary 1-year patency rate, which was 86% for the entire study cohort, was similar for all TASC classifications (89%, 86%, 86%, 85% for TASC A to D lesions, respectively). In the TASC A/B cohort, the 5-year event-free survival (70%) was not significantly better than in the C/D cohort (57%, p=0.124). The clinical outcome, as measured by Rutherford stage and ABI, improved significantly in all TASC subgroups after successful intervention and was maintained up to 1 year. Stenting was an independent predictor for lower restenosis rates (HR 0.517, 95% CI 0.317 to 0.842; p=0.008). CONCLUSION: In experienced hands, endovascular therapy of aortoiliac lesions can be successfully performed with sustained long-term outcome independent of the TASC II classification, even in class D lesions.

Arterial puncture closure using a clip device after transpopliteal retrograde approach for recanalization of the superficial femoral artery.

PURPOSE: To report the safety and efficacy of a clip device to close retrograde popliteal artery puncture sites used in recanalization of the superficial femoral artery (SFA). METHODS: From January 2005 to March 2007, 28 patients (20 men; mean age 66+/-10 years) with stable chronic peripheral artery disease were treated for chronic total SFA occlusion. All patients received aspirin and clopidogrel and were heparinized during the procedure. After failed antegrade recanalization, the SFA was revascularized via a retrograde transpopliteal access. The StarClose Vascular System was used to seal the popliteal artery puncture site. RESULTS: All (100%) interventions were finished successfully, and hemostasis was secured with the StarClose device in all cases. There was 1 (3.6%) major complication with the StarClose system: a transient popliteal artery occlusion induced by plaque shift during sheath removal, which was corrected with balloon angioplasty via the femoral access. Three (10.8%) small hematomas (<5 cm) occurred at the puncture site without causing significant patient discomfort. CONCLUSION: In this small experience, the StarClose Vascular Closure System appeared to be an effective and safe sealing device after percutaneous transpopliteal interventions. Plaque shifting leading to stenosis or occlusion at the puncture site can occur.