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

Autor:	Bosiers M; A.Z. Sint-Blasius, Dendermonde, Belgium - office@fmrp.be., Deloose K; A.Z. Sint-Blasius, Dendermonde, Belgium., Torsello G; St. Franziskus-Hospital, Münster, Germany., Scheinert D; University Hospital of Leipzig, Leipzig, Germany., Verbist J; Imelda Hospital, Bonheiden, Belgium., van den Eynde W; Imelda Hospital, Bonheiden, Belgium., Maene L; Onze-Lieve-Vrouw Hospital, Aalst, Belgium., Beelen R; Onze-Lieve-Vrouw Hospital, Aalst, Belgium., Keirse K; R.Z. Heilig Hart, Tienen, Belgium., Hendriks J; University Hospital of Antwerp, Edegem, Belgium., Callaert J; A.Z. Sint-Blasius, Dendermonde, Belgium., Bosiers M; St. Franziskus-Hospital, Münster, Germany., Wauters J; A.Z. Sint-Blasius, Dendermonde, Belgium.
Jazyk:	angličtina
Zdroj:	The Journal of cardiovascular surgery [J Cardiovasc Surg (Torino)] 2020 Aug; Vol. 61 (4), pp. 471-477. Date of Electronic Publication: 2020 Apr 01.
DOI:	10.23736/S0021-9509.20.11236-9
Abstrakt:	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.
Databáze:	MEDLINE
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