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