CLINICAL STUDY REPORT

Study Title
PREvalence of peripheral arterial disease in acute coronary Syndrome patiENTs
Investigator(s): CHIVESCU ANDREEA IOANA (seria 4, grupa 43)
Data set: Esant54.xls
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 diagnisis of PAD

Methodology: open-label, non-randomized, multicentric , prospective, non-interventional 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; patiens 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 patiens, with the following gender distribution:67% male and 33%female
and with mean age of 62,42 years (60,78 years in male group, respective 65,69 years in female
one).
Cardiovascular risk factors
Cardiovascular risk factors

Count

Hypertension
Diabetes mellitus
Smoking / History of smoking
Dyslipemia
Family history of cardiovascular
disease

NO
YES
NO

21
79
70

Column N
%
21%
79%
70%

YES
NO
YES
NO
YES

30
34
66
16
84

30%
34%
66%
16%
84%

NO
YES

47
53

47%
53%

Personal history of cardiovascular disease

69 of the patients (69 %) were having history of coronary disease (angina pectoris,
myocardial infarction etc),17 patients (17 %) history of cerebrovascular disease (stroke,
TIA, carotid stenosis etc) and 27 of them ( 27 %) history of peripheral arterial disease.
Clinical data at baseline
Mean weight was 82,79 kg (85,45 kg in the male group and 77,48 kg in the female one), mean
height 170,08 cm ( 173,93 cm in the male group and 162,36 cm in the female one) and mean waist
98,31 cm (98,95 cm in the male group, respective 97,06 cm in the female one).
Clinical Data
SBP
DBP Heart Rate
Valid
N Missing

100
0

100
0

99
1

Mean Value

144,23 84,99 73,80

Diagnosis of the coronary disease

26 of the patients ( 26 %) were diagnosed with angina pectoris and 31 of them
( 31%) with myocardial infarction. Mean history of the disease was 2,20 years.
Ankle-Brachial Index (ABI) measurement
ABI measurement
Frequency
Percent

ABI 0,9

32

32%

ABI < 0,9

Total

68

68%

100

100,0%

0%

100

100,0%

Missing
Total

Risk of major cardiovascular events based on ABI values

ABI classification

Frequency

Percent

ABI > 1,4

N

0%

1,4 ABI 0,9

68

68%

ABI < 0,9

32

32%

100

100,0%

0%

100

100,0%

Total
Missing
Total

Antiplatelet therapy recommended at baseline

Therapeutic class

Frequency

Percent

Acetylsalicylic acid + Thienopyridine

69

69%

Thienopyridine

19

19%

Acetylsalicylic acid

4%

Acetylsalicylic acid + Thienopyridine + Others

3%

No treatment

2%

Thienopyridine + Others

1%

Acetylsalicylic acid + Others

2%

Others

0%

100

100%

Total

Major cardiovascular events occurred during the 6 months of follow up

Cardiovascular events
Count
Column N%
Vascular death

Myocardial infarction
Stroke / TIA

No

100

100%

Yes

0%

No

99

99%

Yes

1%

No

88

88%

Yes

12

12%

%69 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
% 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 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

Odds Ratio (95%Cl)

Risk Ratio (95%Cl)

X2

p-value

Hypertension
Diabetes mellitus
Smoking
Dyslipemia
History CV disease
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.
69% 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
17% in those with normal ABI values.
71.9% of the patients were on antiplatelet treatment at the inclusion visit: 56.2% acetylsalicylic
acid, 24.2% thienopyridine and 1.2% others, as monotherapy or in combinations.
Date of report: 17- 01- 2014- Chivescu Andreea-Ioana