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


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2017-09-25

AUTHORS

Stefan Müller-Hülsbeck, Koen Keirse, Thomas Zeller, Herman Schroë, Juan Diaz-Cartelle

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.MethodsThe 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.ResultsPrimary 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.ConclusionMAJESTIC results demonstrated long-term treatment durability among patients whose femoropopliteal arteries were treated with the paclitaxel-eluting Eluvia stent.Level of EvidenceLevel 2b, cohort study More... »

PAGES

1832-1838

References to SciGraph publications

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00270-017-1771-5

DOI

http://dx.doi.org/10.1007/s00270-017-1771-5

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1091920032

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/28948322


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