Acute limb ischemia after occluded femoro-popliteal stents: a comparative analysis between endovascular revascularization vs. open bypass (FOCUS Study)

Background: The aim of the study was to compare the early and medium-term outcomes of endovascular revascularization versus bypass for the treatment of occluded femoro-popliteal stents in patients with acute limb ischemia (ALI) (insights of the OUT-STEPP multicentric registry). Methods: Between January 2016 and December 2021, 317 patients in 14 centers underwent treatment for symptomatic femoro-popliteal In-Stent Occlusion (ISO). Sixty patients with ALI were included into the present study: 42 (70%) underwent endovascular revascularization (Group ENDO), and 18 (30%) underwent open bypass surgery (Group OPEN). Early (30 days) results were assessed and compared between the two groups. Estimated 5-year outcomes were evaluated and compared with the log-rank test. Results: At 30 days no differences were found in terms of Major Adverse Cardiovascular Events (MACEs), acute kidney injury, reintervention(s), major amputation, and all-cause mortality between the two groups. The need for blood transfusions was similar in both groups (Group OPEN 7, 38.9% vs. Group ENDO 13, 30.1%; P=0.14). The mean length of hospital stay was higher for patients in Group OPEN (11.3±6.5 vs. 4.4±1.9 days; P<0.001). The overall median duration of follow-up was 35 (IQR 13-55.75) months. At 5 years there were no differences between the two groups in terms of survival (69.8% Group OPEN vs. 64.6% Group ENDO; P=0.76, log-rank 0.09), overall patency (71.4% Group OPEN vs. 72.8% Group ENDO; P=0.56, log-rank 0.34), freedom from reintervention(s) (76% Group OPEN vs. 63.4% Group ENDO; P=0.32, log-rank 0.99), and amputation-free survival (88.1% Group OPEN vs. 83.4% Group ENDO; P=0.76, log-rank 0.09). Conclusions: Endovascular revascularization and bypass seem to provide effective flow restoration in patients with ALI due to femoro-popliteal ISO. Open surgery was associated with longer hospital stay. At 5 years, no significant differences were found between the two groups in terms of overall patency, need for reintervention(s), and amputation-free survival, even though further studies on a larger sample size and potentially prospective will be necessary to validate these preliminary findings.