Abstract 2736: The Effect of Increased Hemoglobin Concentration on Clinical Outcomes in Patients With Symptomatic Heart Failure and Anemia: Results From STAMINA-HeFT
Background: Heart failure (HF) patients with anemia have more severe symptoms and poorer outcomes than nonanemic patients. This post hoc analysis of STAMINA-HeFT, a randomized, double-blind, placebo-controlled study assessing the safety and efficacy of treating anemia with darbepoetin alfa (DA) in HF, evaluates the effect of categorical changes in hemoglobin (Hb) on exercise duration and clinical outcomes in anemic HF patients treated with DA. Methods: Patients with NYHA class II-IV, LVEF ≤ 40% and Hb 9.0 to 12.5 g/dL were randomized to placebo (n=157) or DA (n=162) subcutaneously every 2 weeks for 1 year (target Hb 14.0 ± 1.0 g/dL). This analysis compared change from baseline in exercise duration at 6 months, the composite of all-cause mortality or HF-related hospitalization, HF-related hospitalization, and all-cause mortality at 1 year between DA-treated patients who achieved a mean Hb increase from baseline of < 1.0 g/dL vs ≥ 1.0 g/dL after study week 17.
Results: Baseline demographics and clinical characteristics of DA-treated patients in the two Hb comparison groups (Hb increase < 1.0 g/dL vs ≥ 1.0 g/dL) were generally similar. At baseline most patients were NYHA class II or III and received beta blockers. The mean (SD) LVEF was 34 (9)% and 35 (10)%, respectively; Hb was 11.5 (0.7) and 11.4 (0.8) g/dL, respectively. Results are shown in the table⇓ suggesting that a ≥ 1.0 g/dL Hb increase in DA-treated patients was associated with better outcomes.
Conclusion: In symptomatic HF patients with anemia treated with DA, a ≥ 1.0 g/dL Hb increase compared with an increase < 1.0 g/dL was associated with significantly longer exercise duration and significantly lower risk of all-cause mortality, HF-related hospitalization and the composite of all-cause mortality or HF-related hospitalization. These data in HF patients support the need for a large, prospective outcomes trial to determine the role of anemia treatment as a potential new therapeutic option in HF.