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CLINICAL RESEARCH: HEART FAILURE

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)

Dirk J. van Veldhuisen, MD^_*,_*, Alain Cohen-Solal, MD, Michael Böhm, MD, Stefan D. Anker, MD, Daphne Babalis, MSc^||, Michael Roughton, PhD^||, Andrew J.S. Coats, MD^¶, Philip A. Poole-Wilson, MD^||, Marcus D. Flather, MBBS^|| SENIORS Investigators

^_* Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands
Hopital Lariboisiere and INSERM, Paris, France
University of Saarland, Homburg/Saar, Germany
Charite Campus Virchow Klinikum, Berlin, Germany
^|| Clinical Trials and Evaluation Unit, Royal Brompton and Harefield NHS Trust, London, United Kingdom
^¶ Faculty of Medicine, University of Sydney, Sydney, Australia

Manuscript received November 12, 2008; revised manuscript received January 27, 2009, accepted February 3, 2009.

^_* Reprint requests and correspondence: Dr. Dirk J. van Veldhuisen, Department of Cardiology, University Medical Center Groningen, University of Groningen, P.O. Box 30.001, 9700RB Groningen, the Netherlands (Email: d.j.van.veldhuisen{at}thorax.umcg.nl).

Objectives: 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 (35%) and preserved EF (>35%).

Background: Beta-blockers are established drugs in patients with HF and impaired EF, but their value in preserved EF is unclear.

Methods: We studied 2,111 patients; 1,359 (64%) had impaired (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.

Results: 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 <0.48.

Conclusions: The effect of beta-blockade with nebivolol in elderly patients with HF in this study was similar in those with preserved and impaired EF.

Key Words: heart failure • elderly • beta-blocker • preserved ejection fraction

Abbreviations and Acronyms   ACE = angiotensin-converting enzyme   ARB = angiotensin receptor blocker   CI = confidence interval   CV = cardiovascular   EF = ejection fraction   HF = heart failure   HR = hazard ratio   LV = left ventricle/ventricular   LVEF = left ventricular ejection fraction

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