Abstract 20721: Death Despite Enalapril Therapy vs. Survival Despite Placebo in the Studies of Left Ventricular Dysfunction (SOLVD) Trial: Insights into the Role of Traditional Risk Factors for Mortality in Heart Failure and Reduced Ejection Fraction (HFrEF)
Background: In the SOLVD trial, 2569 patients with HFrEF (EF≤35%) were randomly assigned to receive either placebo (n=1284) or enalapril (n=1285). During a mean follow-up of 41 months, all-cause mortality occurred in 35% of patients in the enalapril group, a significant 16% relative risk reduction. Although the death rate of 40% in the placebo group, an absolute 5% higher risk than in the enalapril group, 60% of patients in the placebo group survived. The objective of this study was to identify risk factors that were significantly associated with death-despite-enalapril compared with survival-despite-placebo.
Methods: We used a modified nested case-control design, in which cases were the 451 patients who died in the enalapril group and controls were the 774 patients who survived in the placebo group. A multivariable-adjusted logistic regression model was used to estimate odds ratios (OR) and 95% confidence interval (CI) associated with death-despite-enalapril adjusted for 16 baseline characteristics. We then repeated the model among all patients, and separately among those receiving enalapril vs placebo.
Results: Several baseline characteristics emerged as predictors that were associated with a significantly higher odds of death (despite enalapril) versus survival (despite placebo; Table). These same predictors were also associated with mortality among all patients, and separately among those receiving enalapril vs placebo.
Conclusions: Among patients with HFrEF, compared to those surviving on placebo, those who died despite enalapril therapy had the same traditional risk factors as the overall cohort with HFrEF, as well as among those receiving enalapril or placebo. These findings, taken together with the 35% mortality in the enalapril group (87.5% of 40% mortality in the placebo group), suggest that enalapril therapy had no differential effect on traditional risk factors.
Author Disclosures: P.H. Lam: None. D.J. Dooley: None. A. Tsimploulis: None. C. Arundel: None. R. Fletcher: None. J. Butler: None. P. Deedwania: None. M. White: None. I. Kanonidis: None. C. Morgan: None. W. Wu: None. R.M. Allman: None. W. Aronow: None. G. Howard: None. G.C. Fonarow: None. A. Ahmed: None.
- © 2016 by American Heart Association, Inc.