Abstract 17558: Using Patient Reported Outcomes to Predict Patency and Revascularization in Peripheral Artery Disease: A Zilver PTX Sub-Analysis

Introduction: Health status measured by patient reported outcomes (PROs) can predict future major cardiovascular events in patients with peripheral artery disease (PAD). It is unclear, however, whether health status outcomes can also predict revascularization success. Methods: We preformed sub-analysis of the Zilver PTX trial (multinational randomized trial and US single arm) including patients with above-the-knee symptomatic femoropopliteal disease and receiving paclitaxel-eluting stents (Zilver PTX) between 2005-August 2008. We examined the association of patients’ pre-procedural health status measured by EQ-5D-3L Index (EQ-5D), a validated PROs instrument (Value < 0 means health status worse than death, 0: death and 1: full health) and the 12-month treatment durability outcomes measured as primary patency and target lesion revascularization (TLR). Point-biserial correlations were calculated between EQ-5D and outcomes. The 12-month cumulative incidence of patency and TLR was constructed using Kaplan-Meier curves and compared by EQ-5D quartile using Log-rank test. Results: The Zilver PTX arm included 704 patients with a mean age of 68±10 years, 26% women, and 3% Black/African American. The mean EQ-5D pre-procedural Index was 0.79±0.12 and 0.87±0.15 at 12 months. Correlations between the pre-procedural EQ-5D and patency and TLR were, respectively, -0.006 (P=0.82) and 0.034 (P=0.31). In the overall cohort, the cumulative incidence of patency loss was 17% 95%CI 15-21 and of TLR was 9% 95%CI 7-11. There was no significant difference in the 12-month risk of either patency loss or TLR across EQ-5D quartiles (P=0.93 and P=0.85) (Figure). Conclusions: Pre-procedural generic health status are not predictive of post procedural endpoints of revascularization success such as patency and TLR in patients receiving Zilver PTX, underscoring the need of adding these complementary measures to evaluate the full scope of success following revascularization in PAD.