cibis ii
Download
Skip this Video
Download Presentation
CIBIS II

Loading in 2 Seconds...

play fullscreen
1 / 13

CIBIS II - PowerPoint PPT Presentation


  • 252 Views
  • Uploaded on

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).

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about ' CIBIS II' - asher-rivas


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
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)

Placebo Bisoprolol (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

III 1096 (83%) 1106 (83%)

IV 224 (17%) 221 (17%)

Heart failure

Documented ischaemic heart disease 654 (50%) 662 (50%)

Primary dilated cardiomyopathy 157 (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

Placebo Bisoprolol Hazard ratio p

(log rank

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

All-cause hospital admissions 513 (39%) 440 (33%) 0.80 (0.71–0.91) 0.0006

All cardiovascular deaths 161 (12%) 119 (9%) 0.71 (0.56–0.90) 0.0049

Combined endpoint 463 (35%) 388 (29%) 0.79 (0.69–0.90) 0.0004

Permanent treatment 192 (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) by 34%(p<0.0001)
    • Sudden death by 44%(p<0.0011)
    • All-cause hospital admissions by 20%(p<0.0006)
    • Hospital admissions due to worsening heart failure by 36%(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.