EVOLUTION Study: 12-month results.

Autor: Bosiers M; AZ St-Blasius Hospital, Dendermonde, Belgium - marc.bosiers@telenet.be., Deloose K; AZ St-Blasius Hospital, Dendermonde, Belgium., Callaert J; AZ St-Blasius Hospital, Dendermonde, Belgium., Peeters P; Imelda Hospital, Bonheiden, Belgium., Verbist J; Imelda Hospital, Bonheiden, Belgium., van den Eynde W; Imelda Hospital, Bonheiden, Belgium., Maene L; OLV Hospital, Aalst, Belgium., Beelen R; OLV Hospital, Aalst, Belgium., Keirse K; R.Z. Heilig-Hart Hospital, Tienen, Belgium., Wauters J; Flanders Medical Research Program (FMRP), Dendermonde, Belgium.
Jazyk: angličtina
Zdroj: The Journal of cardiovascular surgery [J Cardiovasc Surg (Torino)] 2019 Aug; Vol. 60 (4), pp. 490-495. Date of Electronic Publication: 2019 Jan 28.
DOI: 10.23736/S0021-9509.19.10706-9
Abstrakt: 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.
Databáze: MEDLINE