Background: Prospective, randomized, multicenter trials show no beneficial impact of drug-coated balloon (DCB) therapy alone on the technical and clinical outcomes of infrapopliteal artery lesions in comparison to plain old balloon angioplasty. The aim of this study was to evaluate the performance of directional atherectomy (DA) plus DCB angioplasty versus DCB alone in treatment of long infrapopliteal artery lesions. Methods: We conducted a prospective, randomized, 2-center trial comparing the performance of DA+DCB and DCB alone in treatment of 80 patients with de novo infrapopliteal artery lesions. The primary study end point was the 6-month primary patency of the target lesion detected by angiography and duplex ultrasound. Secondary end points included clinically driven target vessel revascularization, amputation rates, and changes in Rutherford-Becker class at 1 year. A core laboratory provides independent analyses for all scheduled and unscheduled duplex ultrasound examinations and angiographies, and a research institute ensured independent data collection. Results: The mean target lesion length was 179.7±98.2 mm. Nine patients (11.3%) died during the follow-up period. At 6 months, primary patency was 49% (n=18) with DA+DCB versus 34% (n=12) with DCB alone ( P =0.241), and clinically driven target vessel revascularization was 8% (n=3) versus 14% (n=5; P =0.475), respectively. At 1 year, the target lesion revascularization rates were 30% (n=10) versus 43% (n=12; P =0.308), the median in Rutherford-Becker class was 2 (0.25–5) versus 5 (0.25–5; P =0.329), and amputation rates were 22% (n=8) versus 32% (n=11; P =0.618) in the DA+DCB group and the DCB group, respectively. Conclusions: Treatment of long infrapopliteal artery lesions with DA+DCB versus DCB alone leads to comparable clinical and technical results at 6 months and 1 year. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01763476.

The present study was carried out to provide information about outcome of the Jetstream atherectomy device for treatment of infrainguinal arteries. From February 2006 to February 2007, 172 patients with Rutherford class 1 to 5 lower limb ischemia were enrolled at 9 study sites. The endpoints were evaluation of quality of life according to the walking impairment questionnaire (WIQ) besides technical parameters. In the total study cohort, the WIQ scale maintained improved up to 12-month follow-up. Furthermore, target lesion revascularization rate was 26% (42/162), ankle-brachial index (ABI) increased from 0.59 ± 0.21 at baseline to 0.82 ± 0.27 ( P < 0.05), and mean Rutherford class dropped from 3.0 ± 0.9 at baseline to 1.5 ± 1.3 at 1 year ( P < .05). The results of this prospective, multicenter, clinical study demonstrate that the Jetstream atherectomy device is a potential treatment alternative for the endovascular management to improve clinical outcome in patients with peripheral arterial occlusive disease.

Background: Endovascular therapy has become established as a first-line therapy in most arterial regions. However, open vascular surgery (endarterectomy) remains the treatment of choice for common femoral artery (CFA) lesions. The aim of this study is to investigate the acute and mid-term results of directional atherectomy plus drug-coated balloon (DCB) in comparison to endarterectomy in treatment of de novo arteriosclerotic CFA lesions. Methods: This prospective, randomized, multicenter non-inferiority study will enroll 306 participants with symptomatic (Rutherford category 1 to 5) de novo stenosis of the CFA including the bifurcation. Patients eligible for both treatment groups could be included in this 1:1 randomized trial. Primary efficacy endpoint is patency of the target lesion at 12 months defined as restenosis < 50% without the need of clinically driven target lesion revascularization (cdTLR). Primary safety endpoint is a combined endpoint including death, myocardial infarction, major or minor amputation of the target limb, and peri-procedural complications at 30 days. Secondary endpoints include primary patency of the target lesion at 6 and 24 months, secondary patency, cdTLR 6, 12, and 24 months, change in ankle-brachial index, and Rutherford-Becker class at 6, 12, and 24 months. Limb salvage, change in quality of life measured by Walking Impairment Questionnaire, and major adverse events including death, myocardial infarction, and minor or major amputation of the target limb will be determined at 6, 12, 24, and 36 months. Discussion: Endovascular treatment of CFA lesions is still a matter of debate. Few studies compared modern endovascular therapy methods against the so-called gold standard surgical endarterectomy so far. Based on recent positive results, this study aims to confirm non-inferiority of a “leaving nothing behind” endovascular approach combining directional atherectomy and DCB compared to surgical therapy. Trial registration: ClinicalTrials.gov NCT02517827.

Atherosclerotic renal artery stenosis (aRAS) is a disease of the advanced age and may result in deterioration of blood pressure control, renal function and myocardial dysfunction. Since the implementation of stenting endovascular treatment has replaced surgical revascularisation. The benefit of endovascular treatment of aRAS was challenged by the results of the STAR and ASTRAL trials resulting in similar outcomes of revascularisation and conservative treatment. However, these trial results can only be applied to a small proportion of the affected patients due to severe limitations of the both trial designs. Proper indication for renal stenting is the key for clinical success of the endovascular procedure. Most relevant is the identification of the hemodynamically relevance of the lesion by non-invasive (duplex) and invasive (pressure gradient) methods. Moreover, recently some clinical success predictors had been identified which are not yet sufficiently implemented in the decision making process. Unquestioned is the indication for revascularisation in RAS of single functioning kidneys, severe bilateral lesions and in each kind of RAS of non-atherosclerotic nature.