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ORIGINAL ARTICLE  VASCULAR SECTION 

The Journal of Cardiovascular Surgery 2020 February;61(1):84-92

DOI: 10.23736/S0021-9509.19.11028-2

Copyright © 2019 EDIZIONI MINERVA MEDICA

language: English

Endovascular treatment of atherosclerotic lesions in the superficial femoral artery and proximal popliteal artery using the sinus-SuperFlex-635 stent: twelve-month results from the HERO Registry

Jeroen M. HENDRIKS 1 , Marc DUBOIS 2, Patrick LAUWERS 1, Philippe de VLEESCHAUWER 2, Michiel VANBETSBRUGGE 3, Roderik DELEERSNIJDER 3, Karen WUSTENBERGHS 3, Jorn ROBIJN 4, Bart JACOBS 5, Willem WILLAERT 5, Jos VANDEKERKHOF 6, Koen KEIRSE 7, Karen GABRIËLS 8, Mieke HOPPENBROUWERS 1, Dorien HAESEN 8

1 Department of Thorax and Vascular Surgery, Antwerp University Hospital, Edegem, Antwerp, Belgium; 2 Department of Thorax and Vascular Surgery, Heilig-Hartziekenhuis Lier, Antwerp, Belgium; 3 Department of Thorax and Vascular Surgery, GZA Sint-Augustinus Wilrijk, Antwerp, Belgium; 4 Department of Vascular and Thorax Surgery, General Hospital Jan Portaels Vilvoorde, Flemish Brabant, Belgium; 5 Department of Vascular Surgery, General Hospital Maria Middelares Gent, East Flanders, Belgium; 6 Department of Vascular Surgery, Jessa Hospital Hasselt, Limburg, Belgium; 7 Department of Vascular Surgery, Regional Hospital Tienen, Flemish Brabant, Belgium; 8 Archer Research CRO, Limburg, Belgium



BACKGROUND: The aim of this study was to evaluate the safety and performance of the sinus-SuperFlex-635 self-expandable nitinol stent (Optimed GmbH) for the treatment of steno-occlusive lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA).
METHODS: The prospective, multicenter, observational HERO study recruited 117 eligible patients (83 men; mean age 69.4±9.7y) from 7 centers in Belgium.
RESULTS: A total of 129 stents were successfully deployed in 121 lesions in 117 patients (100%). The patients presented with symptomatic ≥50% stenosis or chronic total occlusion (CTO) (30.6%). Mean lesion length was 71.4±56.3 mm. Moderate to severe calcification was present in 82.6% of the lesions. Acute lesion success (<30% residual stenosis) was achieved in 96.0%. There were no in-hospital serious adverse events. Duplex ultrasound-driven primary patency at 12 months was recorded in 84 of 107 (78.5%) lesions. The overall target lesion revascularization (TLR) rate was 8.4% at 12 months; the target extremity revascularization (TER) rate was 4.7%. Clinical assessment at 12 months demonstrated improvement by at least 1 Rutherford class, without the need for TLR (i.e. primary sustained clinical improvement) in 83.9% of patients and with the need for TLR in 90.6% of patients (i.e. secondary sustained clinical improvement).
CONCLUSIONS: Based on the high primary patency, low stent fracture rate and significant clinical improvement, combined with refined stent design and long stent availability, the sinus-SuperFlex-635 self-expandable nitinol stent proves its value in the treatment of complex femoropopliteal lesions.


KEY WORDS: Peripheral artery disease; Self expandable metallic stent; Femoral artery; Popliteal artery; Vascular patency; Multicenter study

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