Bypass or endovascular treatment of femoro-popliteal in-stent occlusion in patients with chronic limb-threatening ischemia (CLTI) have equally efficacious and safe restoration of patency, according to study findings published in the Journal of Vascular Surgery.
Investigators sought to evaluate patients with CLTI treated for occluded femoro-popliteal stents with bypass vs endovascular treatment for a comparison of early- and medium-term outcomes.
They conducted an observational retrospective study using the OUT-STEPP2 multicentric registry to include 161 consecutive patients who received treatment for symptomatic occlusion of femoro-popliteal artery stents between January 2016 and December 2021 at 14 vascular surgery centers in Italy. Patients who were excluded had either lack of follow-up, hybrid revascularization, primary major amputation, acute limb ischemia, or popliteal artery aneurysm as indication for first treatment.
Among the included patients, 46 (mean age, 71.8 years; 30.4% >80 years of age; 71.7% men) received open bypass surgery (Group OPEN) and 115 (mean age, 73.7 years; 31.3% >80 years of age; 62.6% men) received endovascular treatment (Group ENDO). Primary risk factors were similar between Group OPEN vs Group ENDO, with current smokers (47.8% vs 50.4%), hypertension (97.8% vs 93.9%), hypercholesterolemia (93.5% vs 82.6%), and diabetes (65.2% vs 59.1%). Body mass index of greater than 30 was significantly different between groups (34.8% vs 13.9%). Preoperative pharmacological therapy in the OPEN vs ENDO groups included aspirin (73.9% vs 72.2%), clopidogrel (23.9% vs 41.7%), and statin (71.7% vs 74.8%).
There were no between-group differences at 30 days post-procedure for major amputations, reinterventions, acute kidney injury, major adverse cardiovascular events (MACE), or all-cause mortality.
Patients in Group OPEN had greater mean (SD) length of hospital stays (9.7 [5.8] vs 3.3 [1.4] days), mean length of intensive care unit (ICU) stays (0.3 [0.9] vs 0 days), and need for blood transfusions (36.9% vs 11.3%; all P <.001).
Overall, median follow-up duration was 33.1 (IQR, 14-49.5) months. The investigators found no between-group differences at 5 years for limb salvage (77.2% vs 90.4%; P =.17), absence of target lesion restenosis (56.8% vs 62.7%; P =.42), primary patency (56.3% vs 67.8%; P =.39), secondary patency (59.1% vs 77.8%; P =.24), or survival (68.7% vs 68.8%; P =.27).
Study limitations include the observational retrospective design, heterogeneity, and unaccounted-for confounders.
“Both bypass and endovascular treatment provided safe and effective restoration of patency for femoro-popliteal in-stent occlusion in CLTI patients,” the investigators wrote. They noted open surgery was associated with increased use of blood transfusions, and longer stays in the hospital and ICU. “At 5 years, no significant differences were found in the rates of overall patency or limb salvage between bypass and endovascular treatment.”
Disclosure: One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
D’Oria M, Berchiolli R, Gargiulo M, et al.; on behalf of the OUTSTEPP2 collaborative study group. Bypass vs endovascular treatment for occluded femoro-popliteal stents in patients with critical limb-threatening ischemia. J Vasc Surg. Published online July 30, 2023. doi:10.1016/j.jvs.2023.07.053