Purpose: To study the effect of sex on heart failure (HF) characteristics and outcomes.
Methods: This is a sub-analysis of a randomized controlled trial on HF disease management (DM) in which patients with HF (N=1,360; 27.5% women) were randomly assigned to DM (N=682) or usual care (UC) (N=678). DM included multidisciplinary teams of cardiologists and nurses operating in HF centers and a central call center. The primary composite outcome was time-to first hospital admission due to HF or death from any cause.
Results: Compared to men, women recruited in the study were older, with higher prevalence of preserved left ventricular function (LVEF>50%) and lower frequency of Ischemic heart disease (IHD) as the main etiology for HF (p≤0.001). Compared to men, women had worse functional status based on 6-minute walk test and lower scores of quality of life and depression at baseline (p≤0.001). The proportion of patients receiving guidelines-recommended treatment for HF was similar between men and women. During a median follow-up of 2.7 years (range: 0-5), DM was not found to be superior to UC with respect to the primary composite outcome, and there was no significant interaction between sex and the study intervention. Multivariable analysis showed that, controlling for study group and other baseline characteristics, women were significantly less likely than men to experience the primary outcome [HR=0.759, 95%CI: 0.634, 0.908; P=0.0025] or to die from any cause [HR=0.605; 95%CI: 0.475, 0.772; P<0.0001]. Women were also less likely than men to be in a higher category of total number of all cause hospitalizations and in-hospital days [OR=0.77; 95%CI: 0.67, 0.88; and OR=0.72, 95%CI: 0.58, 0.89; respectively).
Conclusions: After adjustment for differences in disease-related and baseline characteristics, women with HF had significantly better outcomes than men with respect to all-cause mortality and recurrent hospitalizations.