CLINICAL STUDY REPORT

Study Title
PREvalence of peripheral arterial disease in acute coronary Syndrome patiENTs
Investigator(s): CHIRIAC SIMONA(III,27)........................................
Data set: ...............3086................
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, AnkleBrachial Index (ABI), antiplatelet treatment recommended at baseline.

Summary:
Population studied: 100 patients, with the following gender distribution: 63% male and
37% female and with mean age of 63.55 years ( 61.79 years in male group, respective
66.54 years in female one).
Cardiovascular risk factors
Cardiovascular risk factors
Hypertension
Diabetes mellitus
Smoking/ History of smoking
Dyslipemia
Family history of cardiovascular
disease

NO
YES
NO
YES
NO
YES
NO
YES
NO
YES

Count Column
N%
22
22%
78
78%
69
69%
31
31%
48
48%
52
52%
19
18%
81
81%
40
40%
60
60%

Personal history of cardiovascular disease

72 of the patients ( 72%) were having history of coronary disease (angina pectoris,
myocardial infarction etc),15 patients ( 15 %) history of cerebrovascular disease (stroke,
TIA, carotid stenosis etc) and 28 of them ( 28%) history of peripheral arterial disease.
Clinical data at baseline
Mean weight was 82.54 kg ( 86.03 kg in the male group and 76.59 kg in the female one), mean
Height 169.33 cm ( 173.67 cm in the male group and 161.95 cm in the female one) and mean
waist 98.24 cm ( 100.54 cm in the male group, respective 94.12 cm in the female one).
Clinical data
Valid
N Missing
Mean value

SBP
100
0
150.03

DBP
100
0
87.83

Heart rate
99
1
75.47

Diagnosis of the coronary disease

65 of the patients ( 65%) were diagnosed with angina pectoris and 35 of them
( 35 %) with myocardial infarction. Mean history of the disease was 5.13 years.
Ankle-Brachial Index (ABI) measurement
ABI measurement
ABI 0.9
N
ABI 0.9
Total
Missing
Total

Frequency
33
65
98
2
100

Percent
33.00%
65.00 %
98%
2%
100%

Risk of major cardiovascular events based on ABI values

ABI classification
ABI > 1.4
1.4 ABI0.9
N
Abi<0.9
Total
Missing
Total

Frequency
0
33
65
98
2
100

Percent
0%
33%
65%
98%
2%
100%

Antiplatelet therapy recommended at baseline

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

Frequency
64
22
5
4
2
0
3
0
100

Percent
64%
22%
5%
4%
2%
0%
3%
0%
100%

Major cardiovascular events occurred during the 6 months of follow up

Cardiovascular events

Vascular death

Myocardial infarction

Stroke / TIA

No
Yes

No
Yes

No
Yes

Count

Column N%

100

100%

0%

100

100%

0%

98

98%

2%

2 % 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
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 28 % ( 28 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 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

X2 used

p-value

0.9314

0.8549

0.9831

0.47 ( 0,27- 0,82 )

0.0104

0.0202

0.0052

0.67 ( 0,47 0.96)

0.98 (0,79 1.20 )
0.77 ( 0, 56 1.06 )

0.4778
0.8558
0.1457

0.0790
0.9186
0.2196

0.0189
0.7796
0.1350

Odds Rattio(95%
CI)

Risk Rattio (95% CI)

Hypertension

0.95 ( 0,33-2.75 )

0.98 ( 0,7 - 1.24 )

Diabetes mellitus

0.30 ( 0,12- 0.77)

Smoking
Dyslipemia
History CV disease

0.40 (0,15 1.00)

0.90 (0,29 2.78)
0.50 (0,19 1.28)

X2
uncorrected

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.
2 % 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
0 % in those with normal ABI values.
98 % of the patients were on antiplatelet treatment at the inclusion visit: 5 % acetylsalicylic
acid, 22 % thienopyridine and 0 % others, as monotherapy or in combinations.
Date of report:30- 12- 2014