SUPERA Interwoven Nitinol Stent Outcomes in Above-Knee IntErventions (SAKE) Study

Purpose: To report experience with the novel interwoven-wire self-expanding nitinol SUPERA stent (IDEV Technologies, Inc/Abbott Laboratories, Inc, Webiter, Texas) for the treatment of severely diseased superficial femoral and popliteal arteries. Materials and Methods: Consecutive patients with severely diseased superficial femoral and popliteal arteries who received SUPERA-stents (n = 80 patients [98 limbs]; mean age, 70.8 y; 80%, Male) were retrospectively identified. Patients-Were followed for an average of 14,3 Months after intervention. Results: Total occlusions were present in 39% Of the lesions, 21% had tissue loss, and 61% demonstrated calcification On fluoroscopy. Patients were prescribed dual antiplatelet therapy (aspirin and cloPidogrel) for, at least 3() days unless contraindicated, followed by aspirin alone indefinitely. The mean (+/- SD) lesion length was 143 mm (+/- 98). Based on need for clinical intervention, primary patency was 96.9% at 6 months and 85.8% at 12 months (Kaplan-Meier estimates). Assisted primary patency and secondary patency rates at 12 months were 96.8% and 100% Ankle brachial increased from 0.60 at baseline to 0.83 at last follow-up (P < .001). No stent fractures were-found by fluoroscopy inspection in 19 limbs (16 patients) that required reintervention. Conclusions: Based on experience with multiple operators at a single clinical Center, the interwoven nitinol stern design provides a viable option for high-grade obstructive disease in the femoropopliteal artery.