Stents With Torsional Strength for Superficial Femoral Artery Disease: The Prospective Q3-Registry

Purpose: This postmarketing surveillance study aimed to assess effectiveness and safety of a peripheral self-expanding stent with high torsional strength (POLARIS stent) for the treatment of de novo superficial femoral artery (SFA) lesions in the routine clinical practice. Materials and Methods: Consecutive patients with symptomatic de novo SFA occlusive disease who underwent POLARIS stent implantation were enrolled into the prospective, multicenter, observational postmarket surveillance study. Primary outcome measure was freedom from clinically driven target lesion revascularization (cdTLR) at 12 months. Main secondary outcomes were procedural success, primary clinical improvement, and freedom from major adverse cardiovascular and limb events (MACLE) throughout 24 months. Results: A total of 199 participants (70±11 years, 70.4% men) were included in the study at 9 German sites from December 2014 to August 2018. Half of them (52.6%) were current smokers, 37.6% had diabetes, and 25.0% were obese. Most participants suffered from intermittent claudication (88.4%). Mean lesion length was 98±83 mm, 43.5% of lesions were occluded, and 27.3% were severely calcified. Freedom from 12 months cdTLR was 94.4% (95% confidence interval [CI], 90.6–98.2). At 24 months, freedom from cdTLR was 88.7% (95% CI, 83.0–94.4). Procedural success was achieved in 96.2% of participants. Primary clinical improvement occurred in 87.5% and 85.4% of participants at 12 and 24 months, respectively. Freedom from MACLE was 94.8% (95% CI, 91.4–98.1) and 93.8% (95% CI, 89.9–97.6) at 12 and 24 months, respectively. Conclusions: Treatment of SFA occlusive disease in a real-world setting using the POLARIS stent with high bidirectional torsional strength is efficacious and does not raise any safety concern in the medium term. The study is registered with ClinicalTrials.gov (Identifier: NCT02307292).

Application of Combined Superficial Femoral Artery Stenting and Deep Femoral Artery Profundoplasty in Chinese Patients With Lower Extremity Artery Disease

Objective: Lower extremity artery disease (LEAD) increases sharply with age and results in severe burden in individuals and in society. This study aimed to compare the efficiency of simple superficial femoral artery stenting (SFAS) and the hybrid operation, such as combined SFAS and deep femoral artery profundoplasty (DFAP), in the treatment of Chinese patients with LEAD, classified as Rutherford grades 3–5.Methods: There were 200 patients with LEAD classified as Rutherford grades 3–5 included in the simple SFAS group (n = 100) and the combined SFAS and DFAP group (n = 100).Results: All the patients had median age of 71 years, and there were 143 males (71.5%). Not only the increase rate of ankle brachial index (ABI), but also reduction rate of Rutherford grade, were significantly higher after surgery in the combined SFAS and DFAP group than in the simple SFAS group (P < 0.05 for all). The patency rate of patients in the combined SFAS and DFAP group was significantly higher than that of patients in the simple SFAS group during the follow-up (P < 0.05). Proportion of amputation and claudication distance <200 m had no significant difference between the two groups during the 2-year follow-up (P > 0.05 for all).Conclusion: This study demonstrated that, compared with SFAS, combined SFAS and DFAP improved not only the ABI and the Rutherford grade after surgery but also the patency rate during the follow-up in Chinese patients with LEAD. Hybrid operation has significant value in alleviating clinical symptoms after surgery, and, thereby, improving vascular prognosis in Chinese patients.

Twisting of the Ranger Drug-Coated Balloon for Treating Superficial Femoral Artery Disease

Paclitaxel-coated balloons have demonstrated improved efficacy compared with uncoated percutaneous transluminal angioplasty for femoropopliteal artery disease. While applying a long balloon, twisting of the balloon can be occurred. We reported two cases with twisting of the Ranger drug-coated balloon for treating superficial femoral artery.