Abstract 20469: Predictors of 1-Year Clinical Outcomes in Real World Patients from XIENCE V® USA Study.
Objectives: The safety and efficacy of XIENCE V® everolimus-eluting stents (XIENCE V) have been demonstrated in SPIRIT trials with low rates of target lesion revascularization (TLR) and major adverse cardiac event. XIENCE V USA is a prospective, multicenter, FDA-required contingency of approval study designed to examine the safety and efficacy of XIENCE V in an all-inclusive population from real-world clinical settings. To better understand the clinical outcomes and the predictors of those outcomes in contemporary practice with XIENCE V, 1-year data from the 5054 patients enrolled in the study were analyzed.
Methods: Patients were enrolled with no inclusion/exclusion criteria beyond signing an informed consent form and the use of only XIENCE V during the index procedure. Events were adjudicated by an independent Clinical Events Committee. To determine the predictors of TLR and target lesion failure (TLF: defined as cardiac death, ARC-defined MI attributed to the target vessel, and clinically indicated TLR), demographic, clinical, and procedural variables were assessed using multivariable, stepwise, logistic regression analysis with independent variables entered into the model at the 0.20 significance level. Variable with higher level of significance was included in the multivariable model for highly correlated variables.
Results: In this real-world population of 5054 patients with about 64% off-label patients, XIENCE V USA demonstrated a low 1-year TLR rate of 4.5% and TLF rate of 8.4%. The independent predictors of TLR and TLF are shown in the table.
Conclusions: In this large, prospective, high quality, single-arm study, XIENCE V showed safety and efficacy in previously unstudied “real-world” patients. Left main and in-stent restenosis lesions have the highest odds ratios for TLR. In-stent restenosis and renal insufficiency have the highest odds ratios for TLF.
- Drug eluting stents
- Interventional cardiology
- Coronary artery disease
- Percutaneous coronary intervention
- © 2010 by American Heart Association, Inc.