ORIGINAL ARTICLE  VASCULAR SECTION 

The Journal of Cardiovascular Surgery 2019 August;60(4):490-5

DOI: 10.23736/S0021-9509.19.10706-9

Copyright © 2019 EDIZIONI MINERVA MEDICA

lingua: Inglese

EVOLUTION Study: 12-month results

Marc BOSIERS ¹ ✉, Koen DELOOSE ¹, Joren CALLAERT ¹, Patrick PEETERS ², Jürgen VERBIST ², Wouter van den EYNDE ², Lieven MAENE ³, Roel BEELEN ³, Koen KEIRSE ⁴, Jeroen WAUTERS ⁵

¹ AZ St-Blasius Hospital, Dendermonde, Belgium; ² Imelda Hospital, Bonheiden, Belgium; ³ OLV Hospital, Aalst, Belgium; ⁴ R.Z. Heilig-Hart Hospital, Tienen, Belgium; ⁵ Flanders Medical Research Program (FMRP), Dendermonde, Belgium

BACKGROUND: The EVOLUTION Study is a prospective, non-randomized study, investigating the iVolution stent (iVascular, Barcelona, Spain). The study was conducted at the vascular departments of four hospitals in Belgium. This manuscript reports the findings up to 12-month follow-up time for the total cohort. The primary endpoint of the study is primary patency at 12 months. Primary patency is defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.4) and without Target Lesion Revascularization (TLR) within 12 months.
METHODS: Between April 2015 and November 2016, 120 patients with TASC A&B femoropopliteal lesions were included. The mean lesion length was 89.63 mm. Most of the lesions were stenotic lesions (60.00%).
RESULTS: Primary patency rate for the total patient population was 86.30% at 12-month follow-up. Freedom from TLR at 12-month was 88.00%.
CONCLUSIONS: These results confirm the already existing enthusiasm of the use of bare metal self-expandable nitinol stents in the treatment of TASC A&B femoropopliteal lesions. Longer follow-up and a comparison or addition with drug-eluting technology has to be studied in the future.

KEY WORDS: Peripheral arterial disease; Stents; Femoral artery; Endovascular procedures