Objective: Thromboembolic events are more frequent in women with established cardiovascular disease taking hormone replacement therapy (HRT). The effect of HRT on the outcome of women with aortoiliac occlusive disease is unknown. The purpose of this study was to estimate the influence of risk factors, including HRT, on the outcome of women undergoing iliac artery angioplasty and stent placement. Methods: During a 5-year period (between 1994 and 1999), 126 iliac angioplasties with stent placement (144 stents) were performed in 88 women. The criteria prepared by the Ad Hoc Committee on Reporting Standards (Society for Vascular Surgery/International Society for Cardiovascular Surgery) were followed to define the variables. Both univariate (Kaplan-Meier) and multivariate analyses (Cox proportional hazards model) were used to determine the association among preoperative variables, cumulative patency, limb salvage, and survival. Results: The patients' average age was 63.2 years with 43% of the patients taking HRT. Indications for iliac angioplasty with stenting were disabling claudication (65%), limb salvage (32%), and blue toe syndrome (3%). The technical success rate was 95% (120 of 126 procedures). Primary stenting was performed in 28 patients (22%). Stents were placed selectively after iliac angioplasty for residual stenosis or pressure gradient (57%), iliac dissection (8%), long-segment occlusions (8%), or eccentric lesions (5%). There were no significant differences between HRT users and nonusers with regard to risk factors, except there was a higher frequency of diabetes in women taking HRT. Overall, the primary patency rate was 76% at 1 year, 67% at 3 years, and 62% at 5 years. Primary patency rates at 1, 3, and 5 years were 75%, 57%, and 49% for users of HRT and 77%, 74%, and 74%, respectively, for nonusers. Limb salvage rates were not statistically different between users and nonusers of HRT at 5 years (95% vs 96%). Univariate and Cox regression analyses identified HRT use (Kaplan-Meier, log-rank test, P = .02; relative risk, 2.4; 95% CI, 1.3-4.5; P = .006) and stent placement in the external iliac artery (relative risk, 4.3; 95% CI, 2.3-7.9; P < .001) as independent predictors of decreased primary patency. Conclusions: Women undergoing iliac angioplasty with stent placement who are taking HRT have significantly reduced primary patency rates. Despite initial technical success, HRT users are at increased risk of long-term failure and might require subsequent procedures to obtain clinical success. External iliac angioplasty and stenting are also associated with decreased primary stent patency in women. (J Vasc Surg 2001;33:S85-92.)