Abstract 12684: Cardiorenal Outcomes and the Efficacy of Darbepoetin in Patients With Heart Failure, Reduced Ejection Fraction, Anemia and Advanced Chronic Kidney Disease
Background: Most trials in heart failure (HF) have excluded patients with advanced chronic kidney disease (CKD) and have not described renal as well as cardiovascular outcomes. We report cardiorenal outcomes in the RED-HF trial which randomized subjects with HF, EF≤40%, anemia, and creatinine ≤ 3 mg/dL to treatment with darbepoetin alfa (DA) or placebo. DA had no effect on mortality or the primary composite outcome of death from any cause or hospitalization for worsening heart failure.
Methods: In RED-HF, we examined the association between CKD stage (defined by the KDOQI classification) and the primary composite outcome as well as the composite of death or end-stage renal disease (ESRD) in multivariable Cox models.
Results: 379 of the 2278 enrolled subjects (16.7%) had Stage IV CKD (eGFR<30 mL/min/1.73m2). Stage IV CKD was associated with older age, female sex, white race, diabetes, hypertension, atrial fibrillation, loop diuretic use, more severe HF symptoms, lower hemoglobin, and lesser use of renin-angiotensin system antagonists at baseline. During a median follow-up of 28 months, 207 (54.6%) of those with Stage IV CKD died and 27 (7.1%) developed ESRD compared to 725 (38.2%) and 26 (1.4%) in the residual population (both p<0.001). Compared to all other CKD stages, those with Stage IV disease were at significantly higher risk for the primary composite outcome as well as the composite of death or ESRD (Figure). There was no impact of DA on composite cardiovascular (interaction p=0.956) or renal (interaction p=0.754) outcomes in any eGFR category.
Conclusions: Relative to those with less severe CKD, HF patients with reduced EF, anemia, and Stage IV CKD have a substantially higher risk of death or HF hospitalization and progression to ESRD. There was no influence of DA treatment on cardiovascular or renal outcomes for any CKD stage.
Author Disclosures: A.S. Desai: Other; Modest; Amgen. H. Krum: None. C. Yu: None. S.M. Wasserman: Employment; Significant; Amgen. E. Apetrei: None. V. Chopra: None. V. Mareev: None. A.P. Maggioni: Consultant/Advisory Board; Modest; Amgen. Other; Modest; Amgen. J.J. McMurray: None. M.A. Pfeffer: Research Grant; Significant; Amgen. Consultant/Advisory Board; Modest; Amgen. Other; Modest; Amgen. K. Swedberg: Research Grant; Significant; Amgen. Consultant/Advisory Board; Modest; Amgen. Other; Modest; Amgen. J.B. Young: Research Grant; Significant; Amgen.
- © 2014 by American Heart Association, Inc.