The Cardiac Insufficiency Bisoprolol Study - CIBIS

Description:

Bisoprolol vs. placebo for 2-year mortality in heart failure.

Hypothesis:

β-blockade, added to standard treatment of diuretics and vasodilators improves survival in moderate-severe heart failure patients. Overall mortality was not decreased.

Study Design

Study Design:

Patients Screened: Not given
Patients Enrolled: 641
NYHA Class: III=(95%), IV=(5%)
Mean Follow Up: 23 months
Mean Patient Age: 59
Female: 17
Mean Ejection Fraction: 25%

Patient Populations:

Chronic heart failure (NYHA Class III-IV)
Not on heart transplant waiting list
Must be on diuretic and vasodilator (preferably ACE inhibitor)
LVEF <40% (measured within 4 weeks of randomization)
Stability for at least six weeks before study entry

Exclusions:

Hypertrophic or restrictive cardiomyopathy
Predominant diastolic dysfunction
Valvular disease not surgically repaired with 6 months of entry
Recent myocardial infarction
Insulin dependent diabetes
Thyroid disease
Systolic blood pressure < 100 or > 160 mmHg
Pulse < 65/min

Primary Endpoints:

All cause mortality (mean follow-up 1.9 years)

Secondary Endpoints:

Tolerability of bisoprolol
Analysis of all critical events (cardiovascular and noncardiovascular)

Drug/Procedures Used:

Bisoprolol (1.25 - 5.0 mg/day)

Concomitant Medications:

ACE inhibitor (90%)
Other vasodilator (40%)
Digitalis (56%)
Diuretic (100%)
Amiodarone (20%)

Principal Findings:

20% risk reduction for mortality with bisoprolol at two years follow-up (p = 0.22).

No significant difference in sudden death or death related to ventricular arrhythmia between groups.

Bisoprolol significantly improved functional status and fewer patients on bisoprolol required hospitalization for cardiac decompensation (90 on placebo versus 61 on bisoprolol; p < 0.01)

More patients on bisoprolol improved at least one NYHA functional class (p = 0.04).

Interpretation:

"Results from this study confirm previous trials evidence that a progressively increasing dose of b-blocker in severe heart failure confers a functional benefit. Subgroup analysis suggested that benefit from b-blockade therapy was greater for those with nonischemic cardiomyopathy. Improvement in survival on b-blockade remains to be demonstrated." (From Abstract)

The CIBIS II trial was terminated early due to a strongly positive effect of beta blockade on heart failure.

References:

1. Circulation 1994; 90:1765-73. Final results
2. Circulation 1997;96(7):2197-205. Hemodynamics

Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, SCD/Ventricular Arrhythmias, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Acute Heart Failure, Heart Transplant

Keywords: Risk Reduction Behavior, Cardiomyopathies, Diuretics, Heart Failure, Bisoprolol, Hospitalization, Death, Sudden, Cardiac, Vasodilator Agents, Heart Transplantation


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