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CIBIS II. Cardiac Insufficiency Bisoprolol Study. CIBIS II Cardiac Insufficiency Bisoprolol Study. Double-blind, placebo-controlled, randomised trial 2,647 patients included (NYHA III + IV) Bisoprolol administered on top of standard therapy (diuretic + ACE inhibitor).

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CIBIS II

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Cibis ii

CIBIS II

Cardiac Insufficiency Bisoprolol Study


Cibis ii cardiac insufficiency bisoprolol study

CIBIS IICardiac Insufficiency Bisoprolol Study

  • Double-blind, placebo-controlled, randomised trial

  • 2,647 patients included (NYHA III + IV)

  • Bisoprolol administered on top of standard therapy(diuretic + ACE inhibitor)


Cibis ii study objectives

CIBIS II - Study Objectives

  • Primary objective

    • All-cause mortality

  • Secondary objectives

    • Cardiovascular mortality

    • Hospital admissions

    • Cardiovascular mortality orcardiovascular hospital admissions

    • Permanent treatment withdrawal


Cibis ii main inclusion criteria

CIBIS II - Main inclusion criteria

  • Ambulatory patients with stable CHF of all aetiologies

  • NYHA functional class III or IV

  • Stable on ACE inhibitor and diuretic

  • Aged 18 – 80 years

  • Left ventricular ejection fraction £ 35%


Cibis ii design

CIBIS II - Design

Bisoprolol dose (mg)

10.00

7.50

5.00

3.75

2.50

1.25

W2

W3

W4

W8

W12

W1

W5

W6

W7

W9

W10

W11

W13

W14

W15

W16

Week

  • No run-in period

  • Dose increased according to tolerability


Cibis ii characteristics i

CIBIS II - Characteristics (I)

PlaceboBisoprolol(n=1320) (n=1327)

Demographic data

Mean (range) age (years)61 (22–80)61 (26–80)

Sex (M/F)1062 (80%)1070 (81%)

258 (20%)257 (19%)

NYHA class

III1096 (83%)1106 (83%)

IV 224 (17%) 221 (17%)

Heart failure

Documented ischaemic heart disease654 (50%)662 (50%)

Primary dilated cardiomyopathy157 (12%)160 (12%)

Others*509 (40%)505 (38%)

Mean (SD) left-ventricular ejection fraction 27.6 (5.5%)27.5 (6.0%)

*Coronary angiography unavailable or no history of myocardial infarction


Cibis ii characteristics ii

CIBIS II - Characteristics (II)

Placebo

Bisoprolol

(n=1320)

(n=1327)

Concomitant medication

Diuretic

1310

(99%)

1305

(98%)

ACE inhibitor

1274

(96%)

1273

(96%)

Dihydropyridine-type calcium antagonist

23

(2%)

23

(2%)

Nitrate

762

(58%)

773

(58%)

Digoxin

670

(51%)

697

(53%)

Amiodarone

206

(16%)

185

(14%)

Anticoagulant

413

(31%)

399

(30%)

Antiplatelet agent

558

(42%)

537

(40%)


Cibis ii survival

CIBIS II - Survival

1.0

0.8

Survival

Bisoprolol: 156 deaths (n = 1327)

Placebo: 228 deaths (n = 1320)

log rank test, p < 0.0001

0.6

0

0

200

400

600

800

Time after inclusion (days)

  • 34% reduction in all-cause mortality with bisoprolol


Cibis ii analysis of time to death

CIBIS II - Analysis of time to death

Patients

100

p=0.0011

80

83

6%

Bisoprolol (n = 1327)

60

Placebo (n = 1320)

p=0.0012

p=0.17

49

4%

48

4%

47

4%

40

p=0.58

36

3%

p=0.41

28

2%

23

2%

23

2%

20

p=0.75

18

1%

14

1%

8

1%

7

1%

0

Sudden

Pump

Myocardial

Other cardio-

Non-cardio-

Unknown cause

death

failure

infarction

vascular deaths

vascular deaths

of death

Hazard ratio:

(95% CI)

0.56

0.74

0.85

1.17

0.75

0.45

(0.39 – 0.80)

(0.48 – 1.14)

(0.31 – 2.34)

(0.67 – 2.03)

(0.37 – 1.50)

(0.27 – 0.74)


Cibis ii secondary endpoints

CIBIS II - Secondary endpoints

PlaceboBisoprolol Hazard ratiop

(log rank

(n = 1320)(n = 1327)(95% Cl)test)

All-cause hospital admissions513 (39%)440 (33%)0.80 (0.71–0.91)0.0006

All cardiovascular deaths161 (12%)119 (9%)0.71 (0.56–0.90)0.0049

Combined endpoint463 (35%)388 (29%)0.79 (0.69–0.90)0.0004

Permanent treatment192 (15%)194 (15%)1.00 (0.82–1.22)0.98withdrawals


Cibis ii mortality by baseline findings

CIBIS II - Mortality by baseline findings

Bisoprolol

Placebo

n/total

n/total

Ischaemia

75/662

121/654

Primary DCM

13/160

15/157

Undefined

68/505

92/509

NYHA III

116/1106

173/1096

NYHA IV

40/221

55/224

Total

Relative risk:

0.4

0.6

0.8

1.0

1.2

1.4

1.6

1.8

  • Mortality did not differ significantly between groupswhatever the aetiology or severity of heart failure


Cibis ii main results at a glance

CIBIS II - Main results at a glance

  • In the bisoprolol-treated group of patients there was a reduction in

    • All-cause mortality (independent of aetiology) by34%(p<0.0001)

    • Sudden death by44%(p<0.0011)

    • All-cause hospital admissions by20%(p<0.0006)

    • Hospital admissions due to worsening heart failure by36%(p<0.0001)


Cibis ii conclusions

CIBIS II - Conclusions

  • CIBIS II successfully demonstrated that ß1-selective bisoprolol – given in addition to standard therapy –reduces significantly all-cause mortality andall-cause hospitalisation in CHF patients.

  • Bisoprolol is the first ß-blocker which has provenits efficacy in a single large-scale CHF studywith all-cause mortality as primary objective.

  • Bisoprolol was as well tolerated as placebowith a permanent treatment withdrawal rate of 15% in both groups.


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