Long-Term Outcomes of Endovascular Therapy for Aortoiliac Bifurcation Lesions in the Real-AI Registry

Purpose To report long-term outcomes of endovascular therapy (EVT) for aortoiliac bifurcation lesions. Methods Patients enrolled in the multicenter REtrospective AnaLysis of Aorto-Iliac stenting (REAL-AI) registry in Japan were pooled. Of 2096 patients who underwent EVT for de novo aortoiliac disease between January 2005 and December 2009, 190 patients (148 men; mean age 70±9 years) had aortoiliac bifurcation lesions that were treated with stents, whose configuration (single, V, or kissing) and type (balloon-expandable or self-expanding) were subjected to regression analysis to determine any impact on primary patency along with other demographic, clinical, and lesion characteristics, including Trans-Atlantic Inter-Society Consensus II C/D classification. The primary endpoints were restenosis and target lesion revascularization (TLR). Secondary endpoints were all-cause death, major cardiovascular events, and major cardiovascular + limb events. Results The overall complication rate was 6.3%, and 1- and 5-year primary patency rates were 87% and 73%, respectively. Over a mean follow-up of 31±15 months, there were 36 (19.0%) restenoses, 22 (11.6%) TLRs, and 4 (2.1%) reocclusions; stent fracture (2, 1.1%) and major amputation (2, 1.1%) were rare. Only female gender [adjusted hazard ratio (AHR) 4.26, 95% CI 1.89 to 9.71, p