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Title
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One-year outcome of the paclitaxel-eluting Legflow balloon catheter in the treatment of long and complex femoropopliteal lesions
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Author
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Abstract
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| BACKGROUND: To investigate the efficacy of the paclitaxel-eluting Legflow balloon catheter in the treatment of “real-world” long and complex femoropopliteal lesions. METHODS: The REFLOW study was a prospective, multi-national, non-randomized, single arm study evaluating the safety and efficacy of the Legflow paclitaxel-eluting balloon dilatation catheter in the treatment of stenotic or occlusive lesions >150mm long in the femoropopliteal arteries of symptomatic patients (Rutherford 2-5). A total of 120 study subjects were enrolled in a period of 30 months, between October 2015 and May 2018. The mean age was 71.1 years and 79 patients were men (65.8%). Mean lesion length was 216.1 mm. 45.0% of the lesions were occluded, whereas 55.0% were stenotic. Primary endpoint was primary patency at 12 months, defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) at the target lesion and without TLR within 12 months. RESULTS: Technical and procedural success (<30.0% residual angiographic stenosis without major complications) was achieved in all 120 cases (100.0%). Primary patency was 84.6 % at 6 months and 71.1% at 1 year. Freedom from TLR was 79.9% at 1 year. CONCLUSIONS: If longer term follow-up confirms there is no safety-concern on these paclitaxel device, the excellent results of the newer drug-eluting devices, and the Legflow paclitaxel-eluting balloon in particular, is a valid and effective alternative to treat long and complex “real-world” femoropopliteal lesions. |
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Language
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English
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Source (journal)
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The journal of cardiovascular surgery. - Torino, 1960, currens
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Publication
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Torino
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Edizioni Minerva Medica
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2020
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ISSN
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0021-9509
[print]
1827-191X
[online]
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DOI
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10.23736/S0021-9509.20.11236-9
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Volume/pages
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61
:4
(2020)
, p. 471-477
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ISI
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000555112900012
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Pubmed ID
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32241092
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Full text (Publisher's DOI)
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