Transcript EUROPA

Baseline characteristics
Patient flow
Registered
13 655
Not randomised
1 437
Randomised
12 218
Perindopril
Placebo
6 110
6 108
Completed
Completed
6 107
6 108
424 centres :
12 218 patients
141
57
134
2068
130
176
115
94
1772
300
277
1251
197
2176
209
399
65
285
830
22
890
102
17
511
Not randomised
%
Intolerance
2.4
Hypotension
2.1
Creatinine/Potassium rise
1.1
Poor compliance
0.6
Major clinical event
0.5
Non medical reasons
0.5
Unspecified
3.3
Overall: 1 437 of 13 655 pts
10.5
Baseline characteristics
Perindopril
Placebo
(mean  SD)
(mean  SD)
Age (yrs)
60  9
60  9
Male (%)
86
85
Weight (kg)
81  12
80  12
HR (bpm)
68  10
68  10
SBP (mmHg)
137  16
137  15
DBP (mmHg)
82  8
82  8
Medical history
Perindopril
Placebo
(%)
(%)
Myocardial infarction
64.9
64.7
Revascularisation
54.7
55.2
Stroke / TIA
3.4
3.3
Heart failure
1.3
1.2
Peripheral vascular
disease
7.1
7.4
Risk factors
Perindopril
Placebo
(%)
(%)
Hypertension
27.0
27.2
Diabetes mellitus
11.8
12.8
Hypercholesterolaemia
63.3
63.3
Current smoker
15.4
15.1
Baseline medication
Perindopril
Placebo
(%)
(%)
Platelet inhibitors
91.9
92.7
-blockers
62.0
61.3
Lipid lowering drugs
57.8
57.3
Nitrates
42.8
43.0
Ca-blockers
31.7
31.0
Diuretics
9.1
9.4
Oral anticoagulants
4.4
4.2
Results
Primary endpoint
% CV death, MI or cardiac arrest
14
Placebo
12
10
Perindopril
8
6
RRR: 20%
p = 0.0003
4
2
0
0
1
2
3
Placebo annual event rate: 2.4%
4
5 Years
Primary
and first secondary endpoint
Perindopril Placebo
better
better
RRR (%)
20
CV mortality, MI, CA
CV mortality
14
Non fatal MI
22
Cardiac arrest
46
Total mortality, MI, UAP,CA
14
0.5
1.0
2.0
Sub-groups analysis
Perindopril better
Placebo better
RRR (%)
Male
19.3
Female
22.0
Age  56 yrs
27.3
Age 57 - 65
14.3
Age > 65 yrs
18.2
Previous MI
22.4
No previous MI
12.1
0.5
1.0
2.0
Sub-groups analysis
Perindopril
better
Placebo
better
RRR (%)
Hypertension
18.6
No hypertension
19.9
Diabetes mellitus
18.9
No diabetes mellitus
19.0
Stroke/TIA
15.8
No stroke/TIA
19.9
0.5
1.0
2.0
Sub-groups analysis
Perindopril
better
Placebo
better
RRR (%)
Lipid lowering drug
16.3
No lipid lowering drug
22.3
-blockers
26.4
No -blockers
7.0
Calcium blockers
15.8
No calcium blockers
22.2
0.5
92% patients on platelet inhibitors
1.0
2.0
Secondary endpoints
Perindopril better
Placebo better
RRR (%)
Total mortality, MI, UAP,CA
14.0
CV mortality & MI
19.3
CV mortality, MI & stroke
17.4
CV mortality, MI, revascularisation
11.3
CV mortality, MI, unstable angina
15.5
Fatal & non fatal MI, unstable angina
16.5
Non fatal and fatal MI
23.9
Total mortality
11.0
CV mortality
13.9
Unstable angina
7.1
Cardiac arrest
45.6
Stroke
4.3
Revascularisation
4.2
Heart failure
39.2
0.5
1.0
2.0
Fatal and non fatal MI
(%) 10
RRR: 24%
p < 0.001
8
Placebo
Perindopril
6
4
2
0
0
1
2
3
4
5 Years
Hospitalisation for heart failure
Placebo
RRR: 39%
p = 0.002
(%) 2.0
1.5
Perindopril
1.0
0.5
0.0
0
1
2
3
4
5 Years
Blood pressure
Perindopril 8mg
Placebo
mmHg
140
130
120
110
SBP: 5 mmHg
DBP: 2 mmHg
100
90
80
70
-1
-1/2
0
3
6
12
18
24
Months
30
36
42
48
54
60
Adherence to treatment
(%) 120
100
80
60
Placebo
Perindopril 8mg
40
20
0
0
6
12
18
Months
24
30
36
Withdrawal from treatment
Perindopril
%
2.7
Placebo
%
0.5
Hypotension
1.0
0.3
Kidney failure
0.3
0.3
Intolerance
2.4
1.3
Study end-point
6.2
7.5
Hypertension
0.4
0.8
Refuse to continue
4.3
4.2
Other reason
5.7
5.8
Cough