Low Blood Pressure

Report
Systolic Heart failure treatment with
the If inhibitor ivabradine Trial
Efficacy and safety of ivabradine in patients
with chronic systolic heart failure according
to blood pressure level in SHIFT
Komajda M et al. Eur J Heart Fail. 2014;16(7):810-816.
www.shift-study.com
Outcomes in placebo patients grouped
according to tertiles of systolic blood pressure
and resting heart rate
Rate of primary end point (cardiovascular mortality or hospitalization for worsening heart failure), %
50
Heart rate at baseline
40
30
≥81 bpm
20
74 to <81 bpm
10
<74 bpm
0
<115<115
mm Hg
115<130
to <130
115 to
mm Hg
>=130
≥130
mm Hg
Systolic blood pressure at baseline
P=0.0058 for
difference between the groups
Komajda M et al. Eur J Heart Fail. 2014;16(7):810-816.
www.shift-study.com
Outcomes in placebo patients according to
tertiles of baseline systolic blood pressure
Rate of primary end point (cardiovascular mortality or hospitalization for worsening heart failure), %
P=0.0003 for difference between the groups
50
<115 mm Hg
40
115 to <130 mm Hg
30
≥130 mm Hg
20
10
0
0
1
Numbers at risk
1069
<115 mm Hg
115 to <130 mm Hg 991
1204
≥130 mm Hg
907
873
1088
Komajda M et al. Eur J Heart Fail. 2014;16(7):810-816.
759
760
970
Time (years)
592
646
823
2
288
350
451
3
117
141
181
6
4
7
www.shift-study.com
Effect of ivabradine on primary outcomes
(CV death or HF hospitalization) according
to systolic blood pressure level
Baseline systolic blood pressure <115 mm Hg
Incidence of primary end point (%)
50
HR 0.84 (95% CI, 0.72 to 0.98), P=0.022
Placebo
40
Ivabradine
30
20
10
0
0
1
Numbers at risk
Time (years)
2
3
Placebo
1069
907
759
592
288
117
6
Ivabradine
1041
911
784
624
287
115
3
Komajda M et al. Eur J Heart Fail. 2014;16(7):810-816.
www.shift-study.com
Effect of ivabradine on primary outcomes
(CV death or HF hospitalization) according
to systolic blood pressure level
Baseline systolic blood pressure 115 to <130 mm Hg
Incidence of primary end point (%)
50
HR 0.86 (95% CI, 0.72 to 1.03), P=0.099
40
Placebo
30
Ivabradine
20
10
0
0
1
Numbers at risk
Placebo
Ivabradine
991
977
873
874
Komajda M et al. Eur J Heart Fail. 2014;16(7):810-816.
760
782
Time (years)
646
664
2
350
381
3
141
131
4
4
www.shift-study.com
Effect of ivabradine on primary outcomes
(CV death or HF hospitalization) according
to systolic blood pressure level
Baseline systolic blood pressure ≥130 mm Hg
Incidence of primary end point (%)
50
HR 0.77 (95% CI, 0.66 to 0.92), P=0.003
40
Placebo
30
Ivabradine
20
10
0
Numbers at risk
Placebo
Ivabradine
0
1204
1223
1
1088
1143
Komajda M et al. Eur J Heart Fail. 2014;16(7):810-816.
970
1034
Time (years)
823
885
2
451
523
3
181
201
7
9
www.shift-study.com
Effect of ivabradine on primary outcomes
(CV death or HF hospitalization) according
to systolic blood pressure level
Rate of primary end point (cardiovascular mortality or hospitalization for worsening heart failure), %
P for interaction =0.68
Baseline SBP <115 mm Hg
Baseline SBP 115 to <130 mm Hg
HR 0.84 (95% CI, 0.72 to 0.98),
P=0.022
50
HR 0.86 (95% CI, 0.72 to 1.03),
P=0.099
HR 0.77 (95% CI, 0.66 to 0.92),
P=0.003
50
Placebo
40
50
40
Ivabradine
30
Baseline SBP≥130 mm Hg
Placebo
30
40
30
20
20
10
10
10
0
0
0
0
1
Time (years)
2
3
Komajda M et al. Eur J Heart Fail. 2014;16(7):810-816.
Placebo
Ivabradine
0
1
Time (years)
2
3
Ivabradine
20
0
1 Time (years) 2
3
www.shift-study.com
Effect of ivabradine on other outcomes
according to baseline systolic blood pressure
P-value
P-value for
interaction
0.24
0.723
0.42
0.91
0.007
0.005
0.001
0.79
0.046
0.033
0.59
0.18
0.36
0.57
0.23
0.90
Adjusted hazard ratio
Cardiovascular mortality
<115 mm Hg
0.89
115 to <130 mm Hg
0.96
≥130 mm Hg
0.91
Hospitalization for worsening heart failure
<115 mm Hg
0.78
115 to <130 mm Hg
0.74
≥130 mm Hg
0.71
Heart failure mortality
<115 mm Hg
0.71
115 to <130 mm Hg
0.58
≥130 mm Hg
1.16
All-cause mortality
<115 mm Hg
0.92
115 to <130 mm Hg
0.94
≥130 mm Hg
0.87
Komajda M et al. Eur J Heart Fail. 2014;16(7):810-816.
www.shift-study.com
Adverse event leading to withdrawal
according to systolic blood pressure level
SBP, mm Hg
<115
≥130
115 to <130
IVA, % PL, %
P
IVA, %
PL, %
P
IVA, % PL, % P
0.3
0.1
0.37
0.9
0.1
0.011
0.7
0.2
0.14
Asymptomatic 0.9
0.2
0.031
1
0.2
0.007
0.6
0.1
0.070
4
4.2
0.43
4
3
0.25
5
3
0.030
Phosphenes
0.5
0
0.029
0
0
0.2
0.2
0.69
Hypotension
0.1
0.2
1.00
0.1
0
0
0
Symptomatic
bradycardia
bradycardia
Atrial
fibrillation
Komajda M et al. Eur J Heart Fail. 2014;16(7):810-816.
0.50
www.shift-study.com

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