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.

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.

Treatment of chronic total occlusions in native coronary arteries by drug-coated balloons without stenting - A feasibility and safety study.

BACKGROUND: Chronic total occlusions remain one of the biggest challenges for interventional cardiologists and the high risk of restenosis and stent thrombosis is still a major problem. Drug-coated balloons showed favorable results for the treatment of in-stent restenosis and other lesion types. The aim of this study was to evaluate the feasibility and outcome of a drug-coated balloon only approach for chronic total occlusion. METHODS: We included 34 patients with a native chronic total occlusion treated only by drug-coated balloons. A visual residual stenosis of 30% or less without major dissection was considered a satisfactory percutaneous intervention result according to the German Consensus Group recommendations for drug-coated balloon use. We collected clinical and procedural data. Angiograms were conducted during the procedure and at follow-up. Quantitative coronary analysis was performed and mean and minimal lumen diameter and late luminal changes were assessed. RESULTS: The recanalization was considered satisfactory in 79.4% (n=27). Restenosis occurred in 11.8% (n=4) and reocclusion in 5.9% (n=2). Out of the 27 patients with a satisfactory initial result, 3.7% (n=1) had reocclusion and 3.7% (n=1) had restenosis. In the subgroup without satisfactory result (n=7), restenosis occurred in 3 patients (42.9%) and reocclusion in 1 patient (14.3%). A luminal increase was found in 67.6% (n=23) and mean late luminal gain was 0.11±0.49mm. Angina class improved significantly (p<0.001). There was no death or myocardial infarction. CONCLUSIONS: Drug-coated balloon angioplasty without stenting is a feasible and well-tolerated treatment method for chronic total occlusions if the predilatation result is good.

Intentional single-stage revascularization of two different vascular beds in patients with vascular multimorbidity; a feasibility study.

AIMS: The aim of this retrospective study was to assess the feasibility of catheter-based interventions in two different vascular beds performed in a single stage in patients with vascular multimorbidity. METHODS AND RESULTS: Fifty patients, 28 males, mean age 68.6 (+/- 9.2) years and 22 females, mean ages 72.2 (+/- 6.4) years were studied. At least one major cardiovascular risk factor was present in 48 (94%) of all patients. The most frequent combination of interventions was coronary artery disease (CAD) and renovascular disease (RVD) (20 patients, 40%) followed by CAD and peripheral artery disease (PAD) (17 patients, 34%). In all patients technical success, defined as residual stenosis < or = 30% diameter, and procedural success, defined as lack of major adverse cardiac and cerebrovascular events (MACCE) during the in-hospital period, were achieved. In two patients surgical revision of the access site was required and in two additional patients minor local bleeding was observed. CONCLUSIONS: Sequential vascular interventions in different vascular beds may be performed in a single stage with high success rates, however, compared to historical controls possibly at a higher rate of access site complications. A larger study using controls is needed to assess the medical benefits and cost efficacy of a single stage approach in patients with clinically relevant vascular multimorbidity.