January 1, 2016Cardiology875 citationsOpen Access
Digoxin in Heart Failure with a Reduced Ejection Fraction: A Risk Factor or a Risk Marker?
Key Points
- This research aims to evaluate the impact of bisoprolol on all-cause mortality in patients with chronic heart failure and reduced ejection fraction.
- Multicentre double-blind randomized placebo-controlled trial in Europe with 2647 symptomatic patients.
Structured PICO
Does bisoprolol reduce all-cause mortality in symptomatic patients with heart failure (NYHA III-IV, LVEF ≤35%) on standard therapy?
P
Population
2647 symptomatic patients in New York Heart Association class III or IV, with left-ventricular ejection fraction of 35% or less receiving standard therapy with diuretics and inhibitors of angiotensin-converting enzyme
I
Intervention
Bisoprolol 1.25 mg daily, progressively increased to a maximum of 10 mg per day
C
Comparator
Matching placebo daily
O
Outcome
All-cause mortalityhard clinical
Bisoprolol significantly reduces all-cause mortality and sudden death in stable patients with symptomatic heart failure and reduced ejection fraction.
Limitations
- Results should not be extrapolated to patients with severe class IV symptoms and recent instability because safety and efficacy has not been established in these patients
Abstract
BACKGROUND: In patients with heart failure, beta-blockade has improved morbidity and left-ventricular function, but the impact on survival is uncertain. We investigated the efficacy of bisoprolol, a beta1 selective adrenoceptor blocker in decreasing all-cause mortality in chronic heart failure. METHODS: In a multicentre double-blind randomised placebo-controlled trial in Europe, we enrolled 2647 symptomatic patients in New York Heart Association class III or IV, with left-ventricular ejection fraction of 35% or less receiving standard therapy with diuretics and inhibitors of angiotensin-converting enzyme. We randomly assigned patients bisoprolol 1.25 mg (n=1327) or placebo (n=1320) daily, the drug being progressively increased to a maximum of 10 mg per day. Patients were followed up for a mean of 1.3 years. Analysis was by intention to treat. FINDINGS: CIBIS-II was stopped early, after the second interim analysis, because bisoprolol showed a significant mortality benefit. All-cause mortality was significantly lower with bisoprolol than on placebo (156 11.8% vs 228 17.3% deaths with a hazard ratio of 0.66 (95% CI 0.54-0.81, p<0.0001). There were significantly fewer sudden deaths among patients on bisoprolol than in those on placebo (48 3.6% vs 83 6.3% deaths), with a hazard ratio of 0.56 (0.39-0.80, p=0.0011). Treatment effects were independent of the severity or cause of heart failure. INTERPRETATION: Beta-blocker therapy had benefits for survival in stable heart-failure patients. Results should not, however, be extrapolated to patients with severe class IV symptoms and recent instability because safety and efficacy has not been established in these patients.
Cite This Study
Konstantinou et al. (2016) studied this question.