Predictors of Major Adverse Limb Events After Endovascular Iliac Stenting: a Real-world Cohort Study

Peripheral arterial disease involving the iliac arteries is a common manifestation of systemic atherosclerosis and a major cause of lifestyle-limiting claudication and chronic limb-threatening ischemia. Endovascular iliac artery stenting has become the preferred treatment strategy for most iliac lesions, including complex TransAtlantic Inter-Society Consensus II (TASC II) C and D lesions, owing to high technical success rates and lower perioperative morbidity compared with open surgical reconstruction. Despite widespread adoption of endovascular treatment, available evidence regarding predictors of major adverse limb events (MALE) after iliac artery stenting remains limited, particularly in unselected real-world populations with substantial comorbidity burden. Patient-related factors, including frailty, may contribute to post-procedural outcomes in addition to lesion-related characteristics. This retrospective single-center cohort study will evaluate clinical outcomes following endovascular iliac artery stenting in consecutive adult patients treated at IRCCS Galeazzi-Sant'Ambrogio Hospital, Milan, Italy. The study will assess the occurrence of major adverse limb events (MALE), primary patency, peri-procedural complications, target lesion revascularization, restenosis or occlusion, and all-cause mortality. Clinical, anatomical, and procedural factors associated with adverse limb outcomes, including frailty assessed by the modified five-item Frailty Index (mFI-5), will also be investigated.

Inclusion Criteria: Adult patients aged ≥18 years, of both male and female sex * Presence of haemodynamically significant stenosis or occlusion of the common iliac artery (CIA) and/or external iliac artery (EIA), documented by computed tomography angiography, magnetic resonance angiography, or diagnostic angiography * Symptomatic peripheral artery disease, including lifestyle-limiting intermittent claudication (Rutherford category 2-3) or chronic limb- threatening ischaemia (CLTI; Rutherford category 4-6), refractory to optimal medical therapy * Treatment with endovascular iliac artery stenting (covered or uncovered; balloon-expandable or self-expanding devices) as the primary revascularisation strategy * De novo iliac lesions only * Availability of complet Exclusion Criteria: Primary open surgical revascularisation of the iliac axis (e.g., aorto- bifemoral bypass or endarterectomy). * Previous stenting of the target iliac segment (in-stent restenosis cases excluded). * Aorto-iliac aneurysmal disease as the primary indication for treatment (including EVAR or fenestrated endografts). * Hybrid procedures with concomitant infrainguinal bypass surgery. * Incomplete clinical, procedural, or follow-up data preventing assessment of study endpoints. * Loss to follow-up without documented clinical outcomes.