Beta-Blockade With Nebivolol in Elderly Heart Failure Patients With Impaired and Preserved Left Ventricular Ejection Fraction: Data From SENIORS (Study of Effects of Nebivolol Intervention on Outcomes and Rehospitalization in Seniors With Heart Failure)

• Published in: Journal of the American College of Cardiology 2009-06, Vol.53 (23), p.2150-2158
• Main Authors: VAN VELDHUISEN, Dirk J, COHEN-SOLAL, Alain, BÖHM, Michael, ANKER, Stefan D, BABALIS, Daphne, ROUGHTON, Michael, COATS, Andrew J. S, POOLE-WILSON, Philip A, FLATHER, Marcus D
• Format: Article
• Language: English
• Subjects: Adrenergic beta-Antagonists - pharmacology; Adrenergic beta-Antagonists - therapeutic use; Age Factors; Aged; Aged, 80 and over; Angiotensin II Type 1 Receptor Blockers - therapeutic use; Angiotensin-Converting Enzyme Inhibitors - therapeutic use; Antihypertensive Agents - pharmacology; Antihypertensive Agents - therapeutic use; Benzopyrans - pharmacology; Benzopyrans - therapeutic use; Biological and medical sciences; Cardiology; Cardiology. Vascular system; Confidence Intervals; Double-Blind Method; Drug therapy; Ethanolamines - pharmacology; Ethanolamines - therapeutic use; Female; Heart; Heart attacks; Heart Failure - drug therapy; Heart Failure - mortality; Heart Failure - physiopathology; Heart failure, cardiogenic pulmonary edema, cardiac enlargement; Hospitalization; Humans; Male; Medical sciences; Mortality; Nebivolol; Stroke Volume - drug effects; Studies; Ventricular Function, Left - drug effects
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2009.02.046

In this pre-specified subanalysis of the SENIORS (Study of Effects of Nebivolol Intervention on Outcomes and Rehospitalization in Seniors With Heart Failure) trial, which examined the effects of nebivolol in elderly heart failure (HF) patients, we explored the effects of left ventricular ejection fraction (EF) on outcomes, including the subgroups impaired EF (< or =35%) and preserved EF (>35%). Beta-blockers are established drugs in patients with HF and impaired EF, but their value in preserved EF is unclear. We studied 2,111 patients; 1,359 (64%) had impaired (< or =35%) EF (mean 28.7%) and 752 (36%) had preserved (>35%) EF (mean 49.2%). The effect of nebivolol was investigated in these 2 groups, and it was compared to explore the interaction of EF with outcome. Follow-up was 21 months; the primary end point was all-cause mortality or cardiovascular hospitalizations. Patients with preserved EF were more often women (49.9% vs. 29.8%) and had less advanced HF, more hypertension, and fewer prior myocardial infarctions (all p < 0.001). During follow-up, the primary end point occurred in 465 patients (34.2%) with impaired EF and in 235 patients (31.2%) with preserved EF. The effect of nebivolol on the primary end point (hazard ratio [HR] of nebivolol vs. placebo) was 0.86 (95% confidence interval: 0.72 to 1.04) in patients with impaired EF and 0.81 (95% confidence interval: 0.63 to 1.04) in preserved EF (p = 0.720 for subgroup interaction). Effects on all secondary end points were similar between groups (HR for all-cause mortality 0.84 and 0.91, respectively), and no p value for interaction was