OBJECTIVES: Erythropoiesis-stimulating agents (ESA) are used in patients who develop anemia secondary to end-stage renal disease (ESRD).  Increase in incidence of thrombosis and death in adult ESRD patients resulted in a warning by the FDA to adjust ESA doses to maintain target hemoglobin of <12 g/dL.   Children with ESRD also develop anemia that ESAs are used to treat.  The objective of this study was to determine cardiovascular outcomes associated with ESA use in pediatric ESRD patients. METHODS: This is a retrospective study using the USRDS database from 2004-2008.  Children 0-19 years old with a diagnosis of anemia (hemoglobin < 5% for age and sex) were included.  Patients with evidence of ESA administration prior to dialysis were excluded.  Patients were classified as having received ESA or no-ESA.  Cardiovascular events (ischemic heart disease, stroke and embolism) were identified using ICD-9 codes.  Logistic regression with cardiovascular event as the dependent variable was undertaken.   Covariates included diabetes, hypertension and hypercholesterolemia.  RESULTS:  Of 2,138,876 patients, 3,226 met the inclusion criteria, 1,302 with ESA and 1,924 without.  The mean age at time of anemia diagnosis was 14.8 years and 14.06 years in the ESA and no-ESA groups, respectively.   A cardiovascular event occurred in 277 patients in the ESA group versus 37 patients in the no-ESA group.  In the regression model, odds ratios for cardiovascular event were 6.71 (95% CI 4.62-9.73) for ESA therapy and 4.27 (95% CI 3.17-5.76) for patients with hypertension.  CONCLUSIONS: ESA therapy in pediatric ESRD patients appears to increase risk of a cardiovascular event in pediatric ESRD patients.  Further study should be undertaken to confirm these results.