Associations of Gender and Etiology With Outcomes in Heart Failure
Associations of Gender and Etiology With Outcomes in Heart Failure
Objectives: This study sought to explore the gender-related differences in etiology and outcomes in chronic heart failure (HF) patients from 5 randomized trials.
Background: Each year, 550,000 new cases of HF are identified; however, there remain limited data on gender-related differences in etiology and outcomes among patients with HF with systolic dysfunction.
Methods: We analyzed data from 8,791 men and 2,851 women randomized in 5 clinical trials (PRAISE [Prospective Randomized Amlodipine Survival Evaluation], PRAISE-2, MERIT-HF [Metoprolol Extended Release Randomized Intervention Trial in Heart Failure], VEST [Vesnarinone Trial], and PROMISE [Prospective Randomized Milrinone Survival Evaluation]) to explore gender-related differences in etiology (ischemic vs. nonischemic) and outcomes (all-cause mortality and death or all-cause hospitalization). Hazard ratios (HR), 95% confidence intervals (CIs), and Kaplan-Meier survival curves were generated by gender and etiology.
Results: A total of 18% of ischemic and 31% of nonischemic patients were women. Irrespective of etiology, women were older, more ethnically diverse, and had higher systolic blood pressures, more diabetes, and severe HF symptoms, but less often smoked or had prior myocardial infarctions than men. Mean ejection fractions were similar between women (23.6%) and men (23.2%). The 1-year Kaplan-Meier survival estimates varied by gender and etiology (female nonischemics, HR 0.88 [95% CI 0.85 to 0.89]; female ischemics, HR 0.83 [95% CI 0.81 to 0.85]; male nonischemics, HR 0.84 [95% CI 0.83 to 0.85]; male ischemics, HR 0.79 [95% CI 0.78 to 0.81]). After adjustment, female gender (HR 0.77 [95% CI 0.69 to 0.85]) and nonischemic etiology (HR 0.80 [95% CI 0.72 to 0.89]) were associated with longer survival time. Time to death or hospitalization was longer among nonischemics (HR 0.83 [95% CI 0.78 to 0.89], p < 0.0001); however, female gender was not significantly associated with the composite outcome (HR 1.01 [95% CI 0.95 to 1.08]).
Conclusions: Our data clarify that outcomes differ by both gender and etiology among patients with HF with systolic dysfunction. Understanding these differences may lead to better management of HF patients and improved overall prognosis. (J Am Coll Cardiol 2007;49:1450–8) © 2007 by the American College of Cardiology Foundation.
Heart failure (HF) affects 5 million people in the U.S., with estimated direct and indirect costs reaching $29.6 billion in 2006. Each year, 550,000 new cases of congestive HF are diagnosed. Advances in medical management have improved the prognosis of HF patients; however, survival remains poor. Although 5-year mortality with HF is lower among women than men (45% vs. 59%), women now account for the majority (62.5%) of deaths from HF in the U.S. because of shifting demographics.
Subset analyses of large-scale trials have attempted to provide insight into gender-related differences in clinical profiles and predictors of outcome, but individually, these analyses are limited by small numbers of female participants and differences in systolic function and definitions of etiology. A pooled analysis of multiple trials provides an opportunity to further explore gender-related differences in etiology, clinical profiles, and outcomes among patients with HF with depressed left ventricular (LV) ejection fraction (LVEF). Therefore, we combined the databases from 5 randomized clinical trials in chronic HF with LV systolic dysfunction (Metoprolol Extended Release Randomized Intervention Trial in Heart Failure [MERIT-HF], Prospective Randomized Amlodipine Survival Evaluation Study [PRAISE], PRAISE-2, Prospective Randomized Milrinone Survival Evaluation [PROMISE], and Vesnarinone Trial [VEST]) in order to: 1) explore differences in clinical profiles by gender and etiology (ischemic vs. nonischemic); 2) investigate characteristics associated with mortality and hospitalization; and 3) examine differences in these clinical outcomes by gender and etiology. In so doing, we sought to better understand the independent associations of gender and HF etiology with clinical outcomes among patients with LV systolic dysfunction.
Abstract and Introduction
Abstract
Objectives: This study sought to explore the gender-related differences in etiology and outcomes in chronic heart failure (HF) patients from 5 randomized trials.
Background: Each year, 550,000 new cases of HF are identified; however, there remain limited data on gender-related differences in etiology and outcomes among patients with HF with systolic dysfunction.
Methods: We analyzed data from 8,791 men and 2,851 women randomized in 5 clinical trials (PRAISE [Prospective Randomized Amlodipine Survival Evaluation], PRAISE-2, MERIT-HF [Metoprolol Extended Release Randomized Intervention Trial in Heart Failure], VEST [Vesnarinone Trial], and PROMISE [Prospective Randomized Milrinone Survival Evaluation]) to explore gender-related differences in etiology (ischemic vs. nonischemic) and outcomes (all-cause mortality and death or all-cause hospitalization). Hazard ratios (HR), 95% confidence intervals (CIs), and Kaplan-Meier survival curves were generated by gender and etiology.
Results: A total of 18% of ischemic and 31% of nonischemic patients were women. Irrespective of etiology, women were older, more ethnically diverse, and had higher systolic blood pressures, more diabetes, and severe HF symptoms, but less often smoked or had prior myocardial infarctions than men. Mean ejection fractions were similar between women (23.6%) and men (23.2%). The 1-year Kaplan-Meier survival estimates varied by gender and etiology (female nonischemics, HR 0.88 [95% CI 0.85 to 0.89]; female ischemics, HR 0.83 [95% CI 0.81 to 0.85]; male nonischemics, HR 0.84 [95% CI 0.83 to 0.85]; male ischemics, HR 0.79 [95% CI 0.78 to 0.81]). After adjustment, female gender (HR 0.77 [95% CI 0.69 to 0.85]) and nonischemic etiology (HR 0.80 [95% CI 0.72 to 0.89]) were associated with longer survival time. Time to death or hospitalization was longer among nonischemics (HR 0.83 [95% CI 0.78 to 0.89], p < 0.0001); however, female gender was not significantly associated with the composite outcome (HR 1.01 [95% CI 0.95 to 1.08]).
Conclusions: Our data clarify that outcomes differ by both gender and etiology among patients with HF with systolic dysfunction. Understanding these differences may lead to better management of HF patients and improved overall prognosis. (J Am Coll Cardiol 2007;49:1450–8) © 2007 by the American College of Cardiology Foundation.
Introduction
Heart failure (HF) affects 5 million people in the U.S., with estimated direct and indirect costs reaching $29.6 billion in 2006. Each year, 550,000 new cases of congestive HF are diagnosed. Advances in medical management have improved the prognosis of HF patients; however, survival remains poor. Although 5-year mortality with HF is lower among women than men (45% vs. 59%), women now account for the majority (62.5%) of deaths from HF in the U.S. because of shifting demographics.
Subset analyses of large-scale trials have attempted to provide insight into gender-related differences in clinical profiles and predictors of outcome, but individually, these analyses are limited by small numbers of female participants and differences in systolic function and definitions of etiology. A pooled analysis of multiple trials provides an opportunity to further explore gender-related differences in etiology, clinical profiles, and outcomes among patients with HF with depressed left ventricular (LV) ejection fraction (LVEF). Therefore, we combined the databases from 5 randomized clinical trials in chronic HF with LV systolic dysfunction (Metoprolol Extended Release Randomized Intervention Trial in Heart Failure [MERIT-HF], Prospective Randomized Amlodipine Survival Evaluation Study [PRAISE], PRAISE-2, Prospective Randomized Milrinone Survival Evaluation [PROMISE], and Vesnarinone Trial [VEST]) in order to: 1) explore differences in clinical profiles by gender and etiology (ischemic vs. nonischemic); 2) investigate characteristics associated with mortality and hospitalization; and 3) examine differences in these clinical outcomes by gender and etiology. In so doing, we sought to better understand the independent associations of gender and HF etiology with clinical outcomes among patients with LV systolic dysfunction.
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