Aortoiliac Atherosclerosis, Aortoiliac Atherosclerosis With Gangrene, Aortoiliac Atherosclerosis Without Gangrene, Aortoiliac Obstruction, Aortoiliac Occlusive Disease, Peripheral Arterial Disease, Peripheral Vascular Diseases
Conditions
Keywords
peripheral artery disease;, aortobifemoral bypass;, aortoiliac stenting;, preoperative care;
Brief summary
This study aims to evaluate the clinical, imaging results of endovascular revascularization of the aorto-iliac sector in comparison with aortobifemoral bypass and the hybrid approach, in patients with atherosclerotic disease of the iliac sector classified as type C and D by the TransAtlantic Inter-Society Consensus (TASC II
Detailed description
Open surgery repair with Aortobifemoral Bypass (ABF) remains the gold standard revascularization technique in patients with lifestyle-limiting intermittent claudication (IC) and chronic limb-threatening ischemia due to extensive Aortoiliac Occlusive Disease (AIOD), particularly in Trans-Atlantic Inter-Society Consensus II (TASC-II) type D lesions The ABF procedure has proven safe, effective, and durable, particularly considering its high long-term patency rates (85%-90% at five years and 75%-80% at ten years) despite its significant peri-operative associated morbidity (1). On the other hand, endovascular treatment (EVT) offers an attractive alternative with durable results (four- or 5-year primary and secondary patency rates ranged from 60% to 86% and 80% to 98%, respectively), especially in less extensive AIOD, while also providing less perioperative morbidity, making it generally preferable for patients with more severe comorbid conditions. Thus, surgical approaches to extensive AIOD have changed considerably over the last years, primarily due to increased EVT, particularly with the uncovered aortoiliac stenting (AIS). While TASC II provides an anatomical framework to compare therapeutic techniques, 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. It is attractive for patients with high surgical risk, given the substantially less perioperative morbidity and mortality compared to ABF This study aims to evaluate the clinical, imaging results of endovascular revascularization of the aorto-iliac sector in comparison with aortobifemoral bypass and the hybrid approach, in patients with atherosclerotic disease of the iliac sector classified as type C and D by the TransAtlantic Inter-Society Consensus (TASC II).
Interventions
PROCEDUREAortobifemoral bypass
Open surgery with aortic and iliac reconstruction
PROCEDUREaortoiliac stenting
Endovascular reconstruction of aortic and iliac arterial obstruction: Balloon angioplasty may be performed initially to dilate the narrowed segment of the iliac artery. Subsequently, a stent delivery system is advanced over the wire and positioned across the lesion. The stent is deployed under fluoroscopic guidance to expand and scaffold the diseased artery, restoring blood flow. Vascular - iliac dedicated Stent - any brand
Sponsors
Clinical Centre of Serbia
University of Padova
University of Bari
University of Trieste
University of Nis
Centro Hospitalar de Vila Nova de Gaia/Espinho
Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro
Centro Hospitalar do Porto
Universidade do Porto
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with peripheral arterial/atherosclerotic disease of the aorto-iliac sector undergoing direct, hybrid or endovascular surgical correction with TransAtlantic Inter-Society Consensus (TASC II) type D classification(12). * Age \>18 years old
Exclusion criteria
* Synchronous aortoiliac aneurysmatic/ectasic disease (aorta AP diameter \>25 mm)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| acute myorcardial infartion | through study completion, an average of 3 years | According to the 4th definition of Myocardial infarction |
| Cardiovascular Death | through study completion, an average of 3 years | Death from cardiovascular disease |
| Major Amputation | through study completion, an average of 3 years | Amputation above the ankle |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death | through study completion, an average of 3 years | Diagnosed by a physician |
| Major Adverse Limb Events | through study completion, an average of 3 years | Amputation above the ankle, arterial thrombosis of the limb, binary restenosis |
| Major adverse cardiovascular events | through study completion, an average of 3 years | acute myocardial infarction; acute heart faillure, cardiovascular death, coronary reintervention |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intensive care unit instay | until 30 days | Intensive care unit instay - days) |
| acute kidney injury (AKI) | until 30 days | AKI according to Riffle criteria |
Countries
Portugal
Outcome results
None listed