Effect of Fixed-Dose Combined Isosorbide Dinitrate/Hydralazine in Elderly Patients in the African-American Heart Failure Trial

Background: Fixed-dose combined isosorbide dinitrate/hydralazine (FDC I/H) significantly improved outcomes in patients with advanced heart failure (HF) receiving background neurohormonal therapy in the African-American Heart Failure Trial (A-HeFT). In this analysis, we investigated treatment effects by age <65 or >= 65 years. Methods and Results: Time-to-event curves were produced by the Kaplan-Meier method. Hazard ratios were calculated with the Cox proportional hazards model. Baseline characteristics showed that patients 65 years old had less hypertensive and more ischemic HF, better quality of life (QoL) scores, higher plasma B-type natriuretic peptide and creatinine levels, and received less background neurohormonal therapy. Kaplan-Meier curves showed that FDC I/H improved mortality and event-free survival in elderly patients. The hazard ratios for mortality, first heart failure hospitalization, and event-free survival (both unadjusted and adjusted for baseline differences), were similar quantitatively and in direction of effect in both age groups. Conclusions: In A-HeFT, FDC I/H improved outcomes in HF patients aged <65 or >= 65 years, despite significant baseline differences between these age groups. Patients aged >= 65 years, a group at greater mortality risk, had the greatest survival benefit from FDC I/H. (J Cardiac Fail 2012;18:600-606)