IUA Committee Research Project on the Management of TASC C and D Aortoiliac Lesions

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).

• Aortobifemoral bypass (Procedure), also known as aortobiliac bypass: Open surgery with aortic and iliac reconstruction
• aortoiliac stenting (Procedure), also known as Percutaneous transluminal aortoiliac stenting; Endovascular treatment of aortoiliac occlusive disease: 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

Primary outcomes

• Major Amputation [through study completion, an average of 3 years]: Amputation above the ankle
• Cardiovascular Death [through study completion, an average of 3 years]: Death from cardiovascular disease
• acute myorcardial infartion [through study completion, an average of 3 years]: According to the 4th definition of Myocardial infarction

Secondary outcomes

• 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
• Death [through study completion, an average of 3 years]: Diagnosed by a physician

Other outcomes

• Intensive care unit instay [until 30 days]: Intensive care unit instay - days)
• acute kidney injury (AKI) [until 30 days]: AKI according to Riffle criteria

Sex: All, ages: 18 Years to any

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)

• Jongkind V, Akkersdijk GJ, Yeung KK, Wisselink W. A systematic review of endovascular treatment of extensive aortoiliac occlusive disease. J Vasc Surg. 2010 Nov;52(5):1376-83. doi: 10.1016/j.jvs.2010.04.080. PMID 20598474
• Groot Jebbink E, Holewijn S, Slump CH, Lardenoije JW, Reijnen MMPJ. Systematic Review of Results of Kissing Stents in the Treatment of Aortoiliac Occlusive Disease. Ann Vasc Surg. 2017 Jul;42:328-336. doi: 10.1016/j.avsg.2017.01.009. Epub 2017 Apr 6. PMID 28390920