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ORIGINAL ARTICLE  VASCULAR SECTION 

The Journal of Cardiovascular Surgery 2020 August;61(4):471-7

DOI: 10.23736/S0021-9509.20.11236-9

Copyright © 2020 EDIZIONI MINERVA MEDICA

language: English

One-year outcome of the paclitaxel-eluting Legflow balloon catheter in the treatment of long and complex femoropopliteal lesions

Marc BOSIERS 1 , Koen DELOOSE 1, Giovanni TORSELLO 2, Dierk SCHEINERT 3, Jürgen VERBIST 4, Wouter van den EYNDE 4, Lieven MAENE 5, Roel BEELEN 5, Koen KEIRSE 6, Jeroen HENDRIKS 7, Joren CALLAERT 1, Michel BOSIERS 2, Jeroen WAUTERS 1

1 A.Z. Sint-Blasius, Dendermonde, Belgium; 2 St. Franziskus-Hospital, Münster, Germany; 3 University Hospital of Leipzig, Leipzig, Germany; 4 Imelda Hospital, Bonheiden, Belgium; 5 Onze-Lieve-Vrouw Hospital, Aalst, Belgium; 6 R.Z. Heilig Hart, Tienen, Belgium; 7 University Hospital of Antwerp, Edegem, Belgium



BACKGROUND: The aim of this study is 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 >150 mm 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.


KEY WORDS: Femoral artery; Popliteal artery; Drug-eluting stents; Balloon angioplasty; Paclitaxel; Endovascular procedures

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