Stefan Müller-Hülsbeck1, Koen Keirse2, Thomas Zeller3, Herman Schroë4, Juan Diaz-Cartelle5. 1. Department of Diagnostic and Interventional Radiology/Neuroradiology, Ev. Luth. Diakonissenanstalt Flensburg, Knuthstr. 1, 24939, Flensburg, Germany. muehue@diako.de. 2. Regional Hospital Heilig Hart Tienen, Tienen, Belgium. 3. Universitäts-Herzzentrum Freiburg - Bad Krozingen, Bad Krozingen, Germany. 4. Ziekenhuis Oost-Limburg, Genk, Belgium. 5. Boston Scientific Corporation, Marlborough, MA, USA.
Abstract
PURPOSE: 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. METHODS: 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 ± 28.1 mm, and 46% of lesions were occluded. Efficacy measures at 2 years 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 3 years included adverse events and TLR. RESULTS: Primary patency was estimated as 83.5% (Kaplan-Meier analysis) at 24 months, and 90.6% (48/53) of patients maintained an improvement in Rutherford class. At 36 months, the Kaplan-Meier estimate of freedom from TLR was 85.3%. No stent fractures were identified, and no major target limb amputations occurred. CONCLUSION: MAJESTIC results demonstrated long-term treatment durability among patients whose femoropopliteal arteries were treated with the paclitaxel-eluting Eluvia stent. LEVEL OF EVIDENCE: Level 2b, cohort study.
PURPOSE: 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. METHODS: 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 ± 28.1 mm, and 46% of lesions were occluded. Efficacy measures at 2 years 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 3 years included adverse events and TLR. RESULTS: Primary patency was estimated as 83.5% (Kaplan-Meier analysis) at 24 months, and 90.6% (48/53) of patients maintained an improvement in Rutherford class. At 36 months, the Kaplan-Meier estimate of freedom from TLR was 85.3%. No stent fractures were identified, and no major target limb amputations occurred. CONCLUSION: MAJESTIC results demonstrated long-term treatment durability among patients whose femoropopliteal arteries were treated with the paclitaxel-eluting Eluvia stent. LEVEL OF EVIDENCE: Level 2b, cohort study.
Authors: Hans I V Lindgren; Peter Qvarfordt; Stefan Bergman; Anders Gottsäter Journal: Cardiovasc Intervent Radiol Date: 2018-03-08 Impact factor: 2.740