Background:
The treatment of patients with complex aortoiliac disease (AID), classified as Trans-Atlantic Inter-Society consensus II (TASC) class C and D, presents a dilemma for vascular surgeons. Current guidelines recommend either open surgical reconstruction (OR), hybrid repair (HR) combining iliac stenting with femoral endarterectomy, or total endovascular repair (ER). While traditional OR with aortobifemoral bypass (ABF) is associated with excellent long term patency results, it is associated with significant perioperative morbidity with some studies citing mortality rates of up to 4-8%. The advancement of endovascular techniques has led to many trials suggesting that endovascular management of TASC II C and D lesions is a potential alternative treatment to open strategies mainly in the subset of patients with high surgical risk, given the substantially less perioperative morbidity and mortality compared to OR.
Aim:
The aim of this trial is to evaluate the short, mid-, and long-term results of open repair, hybrid and endovascular repair in the treatment patients with complex, TASC C and D, aortoiliac lesions.
Methodology:
This is a retrospective cohort study planning to include vascular surgery centers from the following countries: Italy, Portugal, Spain, and Serbia. Data will be collected on demographics, baseline comorbidities, anatomy and morphology of the aortoiliac and femoral bifurcation disease, intraoperative, postoperative, and follow-up data. Propensity score analysis will be performed by matching open repair patients in all three groups (open, hybrid, and endovascular repair) controlling for demographics, baseline comorbidities, anatomical and morphological data.
Endpoints:
Primary endpoints are all-cause mortality and the major adverse limb events (major amputation - below and above the knee, new onset acute limb ischaemia, reintervention of the treated arterial segment). The secondary endpoints are the 30-day complications and primary patency.
All patients (over 18 years of age) with a history of atherosclerotic peripheral arterial disease treated between 1st January 2015 and 1st January 2022
All management strategies will be included (endovascular, hybrid, and open)
Patients who are pregnant
Patients who are under 18 years of age
Patients who have acute limb ischemia or acute on chronic ischemia
Non-atherosclerotic origin of disease: cyclist disease, trauma, dissection
Patient with peripheral arterial disease according to the Rutherford classification system (with claudications and chronic-limb threatening ischemia) undergoing one of the three available treatment option: * Open surgery (aortobifemoral bypass, aortoiliac endarterectomy, iliacofemoral bypass, crossover bypass, axillobifemoral bypass) * Hybrid repair (iliac artery stenting and common femoral artery reconstruction) * Endovascular repair (bare metal stenting, using covered stents, and plain balloon angioplasty)
Cohort
Retrospective
Open surgery
Procedure/SurgeryPatients with complex TASC C and D aortoiliac occlusive disease undergoing open surgery: aortobifemoral bypass, crossover bypass, axillobifemoral bypass, aortoiliac endarterectomy, iliofemoral bypass
Hybrid repair
Procedure/SurgeryPatients with complex TASC C and D aortoiliac occlusive disease undergoing simultaneous open surgical femoral artery reconstruction (endarterectomy, bypass, profundoplasty) and stenting of the iliac axis
Endovascular repair
Procedure/SurgeryPatients with complex TASC C and D aortoiliac occlusive disease undergoing total endovascular repair using different material: bare metal stents (self and balloon expandable), stent-grafts (self and balloon expandable), covered endovascular reconstruction of aortic bifurcation (CERAB), simple plain old balloon angioplasty (POBA)
All-cause mortality
Overall mortality in all treatment arms
Major adverse limb event (MALE)
Major amputations (below and above the knee), new onset acute limb ischaemia of the treated extremity, and reintervention on the already treated arterial segment (aortoiliac segment and femoral bifurcation, excluding distal infrainguinal disease).
30-day complication
Major adverse cardiovascular events (MACE): myocardial infarction, heart failure, stroke, pulmonary embolism; acute kidney injury according to the RIFLE criteria (more than 50% increase of creatinine, and more than 50% drop of estimated glomerular filtration rate (eGFR) compared to the baseline preoperative values) three grades: Injury, Failure, Loss; blood transfusion, bowel ischaemia, urgent reintervention, thrombosis requiring reintervention, bleeding requiring reintervention, wound infection
Primary patency
Computerized tomography or Doppler ultrasound findings of stenosis or occlusion (\>50% stenosis defined as a \>100% increase in the peak systolic velocity relative to the adjacent segments), or a combination of these findings
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Clinical Centre of Serbia
Lead sponsor
University of Belgrade
Collaborator
University of Trieste
Collaborator
Centro Hospitalar De São João, E.P.E.
Collaborator
Clinical Center Nis, University of Nis
Collaborator
Clinical Center Novi Sad, University of Novi Sad
Collaborator
Institute for Cardiovascular Diseases Dedinje
Collaborator
