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

Abstract

To report long-term outcomes of endovascular therapy (EVT) for aortoiliac bifurcation lesions. 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. 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<0.001] and residual diameter stenosis (AHR 1.04, 96% CI 1.01 to 1.06, p=0.01) were independent predictors of primary patency. Stenting for aortoiliac bifurcation lesions was found to be safe and effective. Neither stent configuration nor type appeared to affect vessel patency in true bifurcation lesions.