Efficacy and Safety of a Novel Helical Self-Expanding Nitinol Stent for Femoropopliteal Artery Obliterans Disease

Background: The aim of this study was to evaluate the efficacy and safety of a novel self expanding nitinol stent (Smartflex stent) in femoropopliteal artery obliterans disease. Methods: From June 2016 to May 2019, patients with atherosclerotic occlusion disease of the superficial femoral and popliteal arteries using the Smartflex stents were retrospectively analyzed in our institution. Patients were monitored at 1, 3, 6, and 12 months and annually thereafter. The main characteristics of the diseased vessels, perioperative and follow-up outcome were evaluated. Kaplan-Meier method was used to assess patency rate and the rate of freedom from clinically driven target lesion revascularization (CD-TLR). Results: A total of 50 limbs from 48 patients (mean age 69.4 +/- 8.95 years; 38 men) were included. Eighty-eight Smartflex stents (1.76 stents per limb) were deployed successfully. Of the study patients, 82% had claudication (Rutherford III), 10% had rest pain (Rutherford IV), and 8% had tissue loss (Rutherford V). Trans-Atlantic Inter-Society Consensus II C and D lesions were 26% and 42%, respectively. The mean lesion length was 18.2 +/- 8.5 cm and the mean stented length was 22.3 +/- 9.9 cm. The average follow-up time was 16.4 +/- 8.2 months. Of these lesions, 42 (94%) were chronic total occlusions and 16 (32%) were severely calcified. The primary patency rate at 1 year per Kaplan-Meier estimating, the rate of freedom from CD-TL R at 1 year, and the second patency rate was 83.3%, 88.1%, and 94%, respectively. Among them, 90% patients had improved ankle-brachial indexes (0.47 +/- 0.13 before and 0.84 +/- 0.16 after). No stent fractures and kinking were identified. Conclusions: Stenting of the femoropopliteal artery diseases using the Smartflex stent appeared to be safe and effective. It performed well in long-segment and above knee joint lesions.