Embed Size (px)
DESCRIPTION
S ystolic H eart failure treatment with the I f inhibitor ivabradine T rial. Main results. www.shift-study.com. Swedberg K, et al. Lancet . 2010;376(9744):875-885. Primary composite endpoint (CV death or hospital admission for worsening HF). Cumulative frequency (%). 40. - PowerPoint PPT Presentation
Citation preview
Systolic Heart failure treatment with
the If inhibitor ivabradine Trial
Main results
www.shift-study.comSwedberg K, et al. Lancet. 2010;376(9744):875-885
0 6 12 18 24 30
40
30
20
10
0
Primary composite endpoint (CV death or hospital admission for worsening HF)
18%
Cumulative frequency (%)
Placebo
Ivabradine
HR = 0.82 (0.75–0.90)
P < 0.0001
Months
www.shift-study.comSwedberg K, et al. Lancet. 2010;376(9744):875-885
0 6 12 18 24 30
30
20
10
0
Hospitalization for HF
26%Placebo
Ivabradine
HR = 0.74 (0.66–0.83)
P < 0.0001
Months
Cumulative frequency (%)
www.shift-study.comSwedberg K, et al. Lancet. 2010;376(9744):875-885
Death from heart failure
26%
0 6 12 18 24 30
10
5
0
HR = 0.74 (0.58–0.94)
P = 0.014
Placebo
Ivabradine
Months
Cumulative frequency (%)
www.shift-study.comSwedberg K, et al. Lancet. 2010;376(9744):875-885
Effect of ivabradine on outcomes
Endpoints Hazard ratio 95% CI p value
Primary composite endpoint(CV death or hospital admission for worsening HF)
0.82 [0.75;0.90] p<0.0001
All-cause mortality 0.90 [0.80;1.02] p=0.092
Death from heart failure 0.74 [0.58;0.94] p=0.014
All-cause hospital admission 0.89 [0.82;0.96] p=0.003
Any CV hospital admission 0.85 [0.78;0.92] p=0.0002
CV death/hospital admission for HF or non-fatal MI
0.82 [0.74;0.89] p<0.0001
www.shift-study.comSwedberg K, et al. Lancet. 2010;376(9744):875-885
Age <65 years ≥65 years
Sex Male Female
Beta-blockers No Yes
Aetiology of heart failure Non-ischaemic Ischaemic
NYHA class NYHA class II NYHA class III or IV
Diabetes No Yes
Hypertension No Yes
Baseline heart rate <77 bpm ≥77 bpm
Test for interaction
P = 0.029
1.51.00.5Hazard ratio
Favours ivabradine Favours placebo
Effect of ivabradine in prespecified subgroups
www.shift-study.comSwedberg K, et al. Lancet. 2010;376(9744):875-885
Mean heart rate reduction
70% of patients on ivabradine 7.5 mg bid
0 2 weeks 1 4 8 12 16 20 24 28 32Months
90
80
70
60
50
67
7575
80
64
Heart rate (bpm)
Placebo
Ivabradine
www.shift-study.comSwedberg K, et al. Lancet. 2010;376(9744):875-885
NYHA class changes
28
68
5
24
70
6
0
10
20
30
40
50
60
70
Improvement Stability Worsening
P = 0.0003Patients (%)
Ivabradine
Placebo
www.shift-study.comSwedberg K, et al. Lancet. 2010;376(9744):875-885
Incidence of selected adverse events (n = 6492)
Patients with an event
Ivabradine
N=3232, n (%)
Placebo
N=3260, n (%)p value
All serious adverse events 1450 (45%) 1553 (48%) 0.025
All adverse events 2439 (75%) 2423 (74%) 0.303
Symptomatic bradycardia 150 (5%) 32 (1%) <0.0001
Asymptomatic bradycardia 184 (6%) 48 (1%) <0.0001
Atrial fibrillation 306 (9%) 251 (8%) 0.012
Phosphenes 89 (3%) 17 (1%) <0.0001
Blurred vision 17 (1%) 7 (<1%) 0.042
www.shift-study.comSwedberg K, et al. Lancet. 2010;376(9744):875-885
Patients with an adverse event,
leading to withdrawal
Ivabradine N=3232, n (%)
Placebo N=3260, n (%)
p value
All adverse events 467 (14%) 416 (13%) 0.051
Symptomatic bradycardia 20 (1%) 5 (<1%) 0.002
Asymptomatic bradycardia 28 (1%) 5 (<1%) <0.0001
Atrial fibrillation 135 (4%) 113 (3%) 0.137
Phosphenes 7 (<1%) 3 (<1%) 0.224
Blurred vision 1 (<1%) 1 (<1%) 1.000
Treatment discontinuation
www.shift-study.comSwedberg K, et al. Lancet. 2010;376(9744):875-885
Ivabradine significantly reduces major risks associated
with heart failure:
18% reduction in CV death or hospital admission for worsening HF
26% reduction in death from heart failure
26% reduction in hospital admission for worsening heart failure
Benefits are apparent early, are consistent in
predefined subgroups, and have been
demonstrated on top of recommended therapy
Treatment is well tolerated
Conclusion
www.shift-study.comSwedberg K, et al. Lancet. 2010;376(9744):875-885
