CLINICAL STUDY REPORT

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

Investigator(s): Hill-Crlan Alexandra-Linda (VI,61)

Data set: 6031
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-Branchial
Index (ABI), antiplatelet treatment recommended at baseline.

Summary:
Population studied: 100 patients, with the following gender distribution: 64% male and 36%
female and with the mean age of 63.30 years (62.75 years in male group, respective 64.28
years in female one.)
Cardiovascular risk factors
Cardiovascular risk factors
Hypertension
Diabetes mellitus
Smoking / History of smoking
Dyslipemia
Family history of
cardiovascular disease

Count
25
75
64
36
42
58
15
85
38
62

No
Yes
No
Yes
No
Yes
No
Yes
No
Yes

Column
N%
25,00%
75,00%
64,00%
36,00%
42,00%
58,00%
15,00%
85,00%
38,00%
62,00%

Personal history of cardiovascular disease

72 of the patients (72%) were having history of coronary disease (angina pectoris, myocardial
infarction etc), 19patients (19%) history of cerebrovascular disease (stroke, TIA, carotid stenosis
etc) and 33 of them (33%) history of peripheral arterial disease.
Clinical data at baseline
Mean weight was 82.73 kg (84.27 kg in the male group and 80.00 kg in the female one), mean
height 170.53 cm (174.56 cm in the male group and 163.36 cm in the female one) and mean
waist 91.37 cm (93.02 cm in the male group, respective 88.44 cm in the female one).
Clinical data
Valid
Missing
Mean value
N

SBP

DBP

Heart rate

99
1
139,47

99
1
80,71

99
1
73,16

Diagnosis of the coronary disease

59 of the patients (59%) were diagnosed with angina pectoris and 41 of them (41%) with
myocardial infarction. Mean history of the disease was 3.95 years.
Ankle-Brachial Index (ABI) measurement
ABI measurement
Frequency
30
ABI 0.9
N
ABI < 0.9
68
98
Total
Missing
2
Total
100

Percent
30%
68%
98%
2%
100%

Risk of major cardiovascular events based on ABI values

ABI classification

Frequency

ABI > 1.4

Percent
0%

1.4 ABI 0.9

30

30%

ABI < 0.9

68

68%

Total

98

98%

2%

100

100%

Missing
Total

Antiplatelet therapy recommended at baseline

Therapeutic class

Frequency

Percent

Acetylsaicylic acid +
Thienopyridine

73

73%

Thienopyridine

18

18%

Acetylsaicylic acid

4%

Acetylsaicylic acid +
Thienopyridine + Others

2%

No treatment

0%

Thienopyridine + Others

1%

Acetylsaicylic acid + Others

1%

Others

1%

Total

100

100%

Major cardiovascular events occurred during the 6 months of follow up

Cardiovascular events
Count
Column N%
No
100
100%
Vascular death
Yes
0
0%
No
98
98%
Myocardial infarction
Yes
2
2%
No
98
98%
Stroke / TIA
Yes
2
2%
75% 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 only
25% 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 100% (68 patients with ABI values < 0.9). ABI
measurement is also considered as a generalized atherosclerotic marker hat 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 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 disease (p values of statistical significance are
illustrated below):
Odds Ratio
(95% Cl)

Risk Ratio

X2

X2

(95% Cl)

uncorrected

used

Hypertension

1.36(0.50-3.67)

1.08(0.86-1.35)

0,3769

0,1357

0,5440

Diabetes mellitus

1.83(0.77-4.30)

1.45(0.87-2.43)

1,9109

1,3475

0,1702

Smoking

1.72(0.72-4.11)

1.24(0.89-1.72)

1,5187

1,0341

0,2219

Dyslipemia

1.42(0.42-4.87)

1.05(0.89-1.24)

0,3201

0,0718

0,5761

History CV
disease

1.11(0.47-2.63)

1.04(0.75-1.43)

0,0560

0,0003

0,8153

Risk factors

p-value

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.
75% 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 only
25% in those with normal ABI values.
100% of pacients were on antiplatelet treatment at the inclusion visit: 80% acetylsalicylic
acid, 94% thienopyridine and 5% others, as monotherapy or in combinations.

Date of report: 10.06.2016

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