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Background: Drug-coated balloon angioplasty (DCBA) was shown to be superior to standard balloon angioplasty (POBA) in terms of restenosis prevention for de novo superficial femoral artery disease. For in-stent restenosis, the benefit of DCBA over POBA remains uncertain., Methods and Results: One hundred nineteen patients with superficial femoral artery in-stent restenosis and chronic limb ischemia were recruited over 34 months at 5 German clinical sites and prospectively randomized to either DCBA (n=62) or POBA (n=57). Mean lesion length was 82.2±68.4 mm. Thirty-four (28.6%) lesions were totally occluded; 30 (25.2%) were moderately or heavily calcified. Clinical and duplex ultrasound follow-up was conducted at 6 and 12 months. The primary end point of recurrent in-stent restenosis assessed by ultrasound at 6 months was 15.4% (8 of 52) in the DCBA and 44.7% (21 of 47) in the POBA group (P=0.002). Freedom from target lesion revascularization was 96.4% versus 81.0% (P=0.0117) at 6 months and 90.8% versus 52.6% (P<0.0001) at 12 months, respectively. At 12 months, clinical improvement by ≥1 Rutherford category without the need for target lesion revascularization was observed in 35 of 45 DCBA patients (77.8%) and 23 of 44 POBA patients (52.3%; P=0.015). No major amputation was needed. Two patients in the DCBA and 3 patients in the POBA group died. No death was procedure related., Conclusions: DCBA for superficial femoral artery in-stent restenosis is associated with less recurrent restenosis and a better clinical outcome than POBA without an apparent difference in safety., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01305070., (© 2015 American Heart Association, Inc.)

Purpose: To investigate nitinol stent treatment of superficial femoral artery (SFA) lesions and the impact of different risk factors on the need for clinically driven target lesion revascularization (TLR) in a large, real-world population of claudicants., Methods: Patients presenting with symptomatic SFA stenosis >70% were consecutively enrolled in the 13-center MARIS prospective registry (ClinicalTrials.gov identifier NCT01067885). There was no restriction on lesion length, thus leading to the inclusion of a real-world as well as high-risk patient cohort. The 998 participating patients (657 men; mean age 67.4±9.2 years) had 1050 lesions treated with the same nitinol stent type. The mean lesion length was 9.5±9.6 cm (range 0.5-44; median 8.0); more than a third of the lesions (450, 42.9%) were total occlusions. The primary endpoint was the need for clinically driven target lesion revascularization (TLR) at 12 months., Results: Acute technical success was achieved in 1042 (99.2%) lesions. Restenosis occurred in 187 (23.7%) and reocclusion in 79 (10.0%) lesions at 12 months. The primary endpoint of TLR at 12 months was reached by 136 (17.2%) patients. The periprocedural complication rate was 5.4%. Independent predictors of TLR were female gender [odds ratio (OR) 0.5, 95% confidence interval (CI) 0.3 to 0.7, p<0.001] and lesion length >20 cm vs. 10 cm (OR 2.7, 95% CI 1.1 to 6.6, p=0.029) and 10-20 cm vs. 10 cm (OR 1.9, 95% CI 1.0 to 4.1, p=0.047)., Conclusion: Stent implantation in the SFA is safe and associated with favorable acute and midterm results in a real-world setting. Lesion length and female gender were identified as independent risk factors for TLR.

Purpose: To report a technique to create an extra-large vascular plug for occlusion of a large distal false lumen in chronic aortic dissection., Technique: The "candy-plug" technique is demonstrated in a 58-year-old multimorbid man with a history of complicated acute type B aortic dissection and a 9-cm chronic thoracic false lumen aneurysm. The patient underwent a staged repair with a cervical debranching procedure as a first step and a thoracic endovascular aortic repair from the innominate artery to the celiac artery as a second step. To occlude the large false lumen from a distal route, a stent-graft was modified on-table with a diameter-restricting suture, giving it a wrapped candy-like shape. This plug was deployed into the false lumen, and the remaining opening was occluded with a standard vascular plug. On 3-month follow-up imaging, the thoracic false lumen aneurysm remained completely thrombosed., Conclusion: The candy-plug technique can facilitate complete occlusion of chronic thoracic false lumen aneurysm by prohibiting distal false lumen backflow.