Endovascular Treatment Versus Hybrid Repair for Iliofemoral Occlusive Disease: A Pilot Prospective Randomized Trial

ABSTRACT Background The treatment of patients with a simultaneous lesion of the iliac and common femoral arteries presents a significant challenge. Aim The objective of pilot randomized trial (ClinicalTrials.gov) was to compare the short and 3‐year safety and efficacy of endovascular treatment (EVT) and hybrid repair (HR) procedures with using an interwoven nitinol stent for patients with coexisting iliac and common femoral occlusive disease. Materials and Methods In the EVT group patients after recanalization and balloon angioplasty iliac and common femoral arteries were treated with interwoven nitinol stents. In the HR group, patients underwent recanalization and stenting of iliac arteries as in the EVT group but endarterectomy and patch angioplasty for the common femoral artery. Perioperative 1, 2, and 3‐year outcomes were compared between both groups. Results Totally 62 patients were randomized (31 EVT and 31 HR). The average hospital length of stay was shorter in EVT group (3.9 ± 1.2 days EVT group vs. 7.9 ± 2.7 days HR group, p = 0.001). There were no mortalities, no MACEs in either group within 30 days post‐op. Thirty‐day perioperative morbidity rate was 9.7% in EVT group versus 22.6% in HR group ( p = 0.17). The primary patency rate at 12, 24 and 36 months was 81%, 60%, and 46% in the EVT group, 94%, 80%, and 73% in the HR group ( p = 0.12, p = 0.09, and p = 0.03). The secondary patency rates at 36 months in EVT group was 83% versus 87% in HR group, respectively ( p = 0.64). Survival and limb salvage rates did not differ between groups at 36 months of follow‐up (93% vs. 93% p = 0.97% and 97% vs. 100% p = 0.31 respectively). Conclusions This study supports that the hybrid treatment has an advantage over EVT in terms of safety and primary patency in the mid‐term follow‐up period. However, a larger study is needed to confirm these findings and further investigate the long‐term effects of the hybrid approach.