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CLINICAL STUDY REPORT

Study Title
PREvalence of peripheral arterial disease in acute coronary Syndrome patiENTs

Investigator(s): Pistea Maria-Madalina, seria II, grupa 15


Data set: 2064
Objectives:
Primary:

To evaluate the prevalence of Peripheral Arterial Disease (PAD) in patients admitted in


hospital with diagnosis of ACS or outpatients after an ACS (within last 6 months),
ambulatory checked.

Secondary:

To identify the Main Clinical Variables associated with a higher risk of PAD among
this population
To evaluate the therapeutic management of these patients
To train Cardiologists to measure Ankle / Brachial Index (ABI) in order to improve
diagnosis of PAD

Methodology: open-label, non-randomized, national, multicentric, prospective,


noninterventional study

Number of patients/subjects: 100


Evaluated:
ABI (Cut-off for PAD 0,9)
Epidemiological data:
atherothrombotic risk factors
cardiovascular previous events
treatments prescribed at visit 1 (by therapeutic class)

Diagnosis and criteria for inclusion:


Inclusion Criteria: patients > 40 years admitted in hospital with diagnosis of Acute
Coronary Syndrome or outpatients after an ACS (within last 6 months), ambulatory
checked; informed consent signed
Exclusion Criteria: patients < 40 years; patients who did not sign the informed consent
form; patients enrolled in other studies

Criteria for evaluation:


Will be collected: demographic data of the patient, cardiovascular risk factors,
personal history of cardiovascular diseases, clinical data, diagnosis of coronary disease,
Ankle-Brachial Index (ABI), antiplatelet treatment recommended at baseline.

Summary:
Population studied : 100 patients , with the following gender distribution 75% male and
25% female and with mean age of 63.86 years (63.5 years in male group , respective
64.92 years in female one).

Cardiovascular risk factors


Count

Column N%

No

23

23%

Yes

77

77%

No

67

67%

Yes

33

33%

No

31

31%

Yes

69

69%

No

19

19%

Dyslipemia

Yes

81

81%

Family history of cardiovascular disease

No

48

48%

Yes

52

52%

Cardiovascular risk factors


Hypertension
Diabetes miellitus
Smoking / History of smoking

Personal history of cardiovascular disease


73 of the patients (73%) were having history of coronary disease (angina pectoris,
myocardial infarction etc), 21 patients (21%) history of cerebrovascular disease (stroke,
TIA,carotid stenosis etc) and 36 of them (36%) history of peripheral arterial disease.

Clinical data at baseline


Mean weight was 81.91 kg (84.08 kg in the male group and 75.4 kg in the female one),
mean height 170.33 cm (173.12 cm in the male group and 161.96 cm in the female one)
and mean waist 98.49 cm (100.08 cm in the male group, respective 93,79 cm in the
female one).
Clinical data

SBP

DBP

Heart rate

Valid

100

100

99

Missing

143.36

83.64

75.20

Mean value

Diagnosis of the coronary disease


37 of the patients (37 %) were diagnosed with angina pectoris and 22 of them ( 22%)
with myocardial infarction.

Ankle-Brachial Index (ABI) measurement


ABI measurement

Frequency

Percent

ABI 0.09

31

31%

ABI < 0.09

68

68%

Total

99

99%

Missing

1%

Total

100

100%

Risk of major cardiovascular events based on ABI values


ABI classification

Frequency

Percent

ABI > 1.4

0%

1.4 ABI 0.9

31

31%

ABI < 0.9

68

68%

Total

99

99%

Missing

1%

Total

100

100%

Antiplatelet therapy recommended at baseline


Therapeutic class

Frequency

Percent

Acetylsalicylic acid +
Thienopyridine
Thienopyridine
Acetylsalicylic acid
Acetylsalicylic acid +
Thienopyridine + Others
No treatment
Thienopyridine + Others
Acetylsalicylic acid + Others
Others
Total

64

64%

29
4
3

29%
4%
3%

0
0
0
0
100

0%
0%
0%
0%
100%

Major cardiovascular events occurred during the 6 months of follow up


Cardiovascular events
Vascular death Yes
Myocardial
infarction
Stroke/ TIA

Count
0

Column N%
0%

No
Yes
No
Yes

100
1
99
3

100%
1%
99%
3%

No

97

97%

4% of the major cardiovascular events (vascular death, myocardial infarction and


stroke/TIA) occurred during the 6 months of follow up in the group of patients with ABI
values < 0.9 and 0% in those with normal ABI values.

Conclusions:

The prevalence of Peripheral Arterial Disease (PAD) based on ABI measurement in the
cohort of 100 patients admitted to hospital with diagnostic of ACS or outpatients after an
ACS (within last 6 months), ambulatory checked was of 68% ( 68 patients with ABI
values < 0.9). ABI measurement is also considered as a generalized atherosclerotic
marker that may allow identifying patients at high risk for developing cardio or
cerebrovascular events: on top of the patients with ABI values lower than 0.9 there were
those 0 ones with ABI values > 1.4 ( 0%) indicating arterial stiffness and, as already
mentioned, risk of major cardiovascular events.
The main variables associated with a higher risk of PAD that have been identified among
this population were the following risk factors: hypertension, diabetes mellitus, present
smoking or history of smoking and history of cardiovascular diseases (p values of
statistical significance are illustrated below):
Risk factors
Hypertension
Diabetes mellitus
Smoking
Dyslipemia
History CV
disease

Odd-ratio (95%CI)
0.81 (0.30-2.18)
0.83 (0.34-2.01)
0.37 (0.15-0.92)
2.87 (0.77-10.70)
0.69 (0.29-1.61)

Risk-ratio(95%CI)
0.95 (0.74-1.21)
0.89 (0.51-1.56)
0.71 (0.50-1.01)
1.18 (0.99-1.40)
0.83 (0.53-1.29)

X2

X2

uncorrected

used

0.16
0.16
4.71
2.63
0.72

0.16
0.15
4.67
2.60
0.72

The logistic regression calculation (taking into account all these risk factors
simultaneously)identified that hypertension, diabetes mellitus, present smoking or history
of smoking,dyslipemia as well as history of cardiovascular disease are all risk factors
with major impact on Peripheral Arterial Disease induction.
4% of the major cardiovascular events (vascular death, myocardial infarction and
stroke/TIA)occurred during the 6 months of follow up in the group of patients with ABI
values < 0.9 and 0 % in those with normal ABI values.
100% of the patients were on antiplatelet treatment at the inclusion visit: 71%
acetylsalicylic acid, 96 % thienopyridine and 3 % others, as monotherapy or in
combinations.

Date of report: 5.01.2015

p-value
0.31
0.35
0.018
0.05
0.20

Date of report: 5.01.2015