Long-Term Results from the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Femoropopliteal Treatment: 3-Year Follow-up.

Abstract

To report the 3-year results of the MAJESTIC first-in-human study of the Eluvia Drug-Eluting Vascular Stent System for treating femoropopliteal artery lesions. The prospective, single-arm, multicenter clinical trial enrolled 57 patients with symptomatic lower limb ischemia (Rutherford category 2, 3, or 4) and lesions in the superficial femoral artery or proximal popliteal artery. Mean lesion length was 70.8±28.1mm, and 46% of lesions were occluded. Efficacy measures at 2years included primary patency, defined as duplex ultrasound peak systolic velocity ratio of ≤2.5 and the absence of target lesion revascularization (TLR) or bypass. Safety monitoring through 3years included adverse events and TLR. Primary patency was estimated as 83.5% (Kaplan-Meier analysis) at 24months, and 90.6% (48/53) of patients maintained an improvement in Rutherford class. At 36months, the Kaplan-Meier estimate of freedom from TLR was 85.3%. No stent fractures were identified, and no major target limb amputations occurred. MAJESTIC results demonstrated long-term treatment durability among patients whose femoropopliteal arteries were treated with the paclitaxel-eluting Eluvia stent. Level 2b, cohort study.