The treatment of iliac artery occlusive disease with SE as compared with BE resulted in a lower 12-month restenosis rate and a significantly reduced TLR rate. No safety concerns arose in both groups. (Iliac, Common and External [ICE] Artery Stent Trial; NCT01305174).

Conclusion: Drug-coated balloon angioplasty (DCBA) for superficial femoral artery (SFA) in-stent restenosis (ISR) is associated with less recurrent restenosis and a better clinical outcome than plain old balloon angioplasty (POBA) with no apparent differences in safety. Summary: Treatment of femoropopliteal artery stenotic and occlusive lesions has become main stream in recent years. However, many times long term primary patency rates are suboptimal and as a result treatment of ISR has become increasingly important. For ISR the benefit of treatment with percutaneous techniques using DCBA or POBA remains uncertain. The authors recruited 119 patients with SFA IRS and chronic ischemia over a period of 34 months from five German clinical sites. Patients were randomized to either DCBA (n ¼ 62) or POBA (n ¼ 57). Mean lesion length was 82.2 6 68.4 mm, 28.6% (n ¼ 34) lesions were occluded; 30 (25.2%) were mildly or heavily calcified. Clinical and duplex ultrasound follow-up was conducted at 6 and 12 months. The primary end point was recurrent IRS assessed by ultrasound at 6 months and was 15.4% in the DCBA group, and 44.7% in the POBA group (P ¼ .002). Freedom from target lesion vascularization was 96.4% vs 81.0% (P ¼ .001117) at 6 months and 90.8% vs 52.6% (P < .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 ¼ .015). There were no major amputations performed. Two patients in the DCBA and three patients in the POBA group died. No death was procedure related. Comment: The study is among the first to systematically examine treatment of SFA medium length IRS lesions with DCBA and that it is associated with lower recurrent ISR and target lesion revascularizations at 6 and 12 months than POBA. If angioplasty with drug coated balloons is superior to POBA, and it appears that it is from multiple studies, there is no reason to be surprised by this current study results given that there is no substantial evidence that recurrent restenosis is any different biochemically than primary restenosis. However, it is still too soon to relegate POBA to a procedure of the past. Cost effectiveness trials and trials of meaningful clinical importance such as limb salvage and quality of life benefit still need to be performed in regard to treatment of ISR using POBA vs DCBA.

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

Endovascular procedures for pelvic, upper limb, and below-the-knee disease are accompanied with a higher radiation exposure of the operator than with coronary procedures.

One-year results suggest that bioresorbable vascular scaffolds for de novo coronary artery disease are associated with favourable clinical and functional outcomes in routine clinical practice despite a visually overestimated RVD.

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.

Background: The optimal revascularization therapy for in-stent restenosis (ISR) of femoropopliteal arteries represents a matter of debate. We investigated the outcomes of patients treated with drug-coated balloon (DCB) angioplasty for ISR of femoropopliteal arteries. Methods and Results: Patient-level data from 3 randomized trials of DCB angioplasty for ISR of femoropopliteal arteries were pooled. The primary outcome was target lesion revascularization. The main secondary outcome was recurrent ISR. Other outcomes of interest were ipsilateral amputation, death, Rutherford class improvement, and ankle-brachial index at follow-up. A total of 263 patients randomly assigned to DCB (n=133) or plain balloon angioplasty (n=130) were included in the analysis. After a follow-up of 12 months, patients treated with DCB angioplasty displayed a lower risk for target lesion revascularization (hazard ratio [95% CIs]: 0.25 [0.14–0.46]; P <0.001) and recurrent ISR (0.19 [0.10–0.35]; P <0.001) as compared with those treated with plain balloon angioplasty. There was no significant interaction between the treatment effect for target lesion revascularization and high-risk subgroups of patients such as those with diabetes mellitus, longer lesions, small vessels, moderate to severe underlying calcification, and occlusive pattern of ISR. DCB and plain balloon angioplasty were comparable with respect to other secondary outcomes. Conclusions: In case of femoropopliteal ISR, the percutaneous treatment with DCB angioplasty is associated with superior clinical and antirestenotic efficacy as compared with plain balloon angioplasty at 1-year follow-up, without attrition of efficacy in high-risk subgroups of patients. The long-term durability of DCB angioplasty in this setting remains to be further investigated.

Purpose This study aimed to assess 5-year effectiveness and safety of femoropopliteal angioplasty with the Luminor® 35 drug-coated balloon (DCB). Materials and Methods The EffPac trial was a prospective, multicenter, randomized controlled trial that enrolled 171 patients of Rutherford category 2 to 4 with medium length femoropopliteal lesions. Patients were allocated 1:1 to either Luminor® 35 DCB angioplasty or plain old balloon angioplasty (POBA). Assessment at 5 years included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), clinical improvement, and target limb amputation. Long-term vital status was ascertained in 97.1% of the participants. Results Kaplan–Meier curves at 5 years demonstrate a primary patency of 61.4% after DCB angioplasty and 53.5% after POBA (log-rank p = 0.040) with a decreasing difference throughout the observation period. Freedom from TLR was 82.1% and 73.7%, respectively (log-rank p = 0.050). Incidence of primary clinical improvement was similar between groups (61% DCB vs. 64% POBA, p = 0.94). Major target limb amputation was necessary in one POBA-group participant. Freedom from all-cause death at 5 years was 88.5% after DCB and 86.0% after POBA (log-rank p = 0.34). Conclusions Primary patency after femoropopliteal DCB angioplasty remained superior to POBA throughout 5 years, however, with decreasing difference. Clinical improvement, freedom from TLR, and all-cause mortality were similar between groups over the long term. (Effectiveness of Paclitaxel-Coated Luminor® Balloon Catheter Versus Uncoated Balloon Catheter in the Superficial Femoral Artery [EffPac]; NCT02540018).