CLINICAL STUDY REPORT

Study Title
PREvalence of peripheral arterial disease in acute coronary Syndrome patiENTs
Investigator(s): .....POPESCU Ion (XX, 222)........................................
Data set: 101
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: 2683

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: 2683 patients, with the following gender distribution: 67.3% male and
32.7% female and with mean age of 63.75 years (65.95 years in male group, respective
65.37 years in female one).
Cardiovascular risk factors
Cardiovascular risk factors

Count Column N %

Hypertension

Diabetes mellitus

Smoking / History of smoking

Dyslipemia

Family history of cardiovascular disease

No

549

20.5%

Yes

2134

79.5%

No

1694

63.1%

Yes

989

36.9%

No

973

36.3%

Yes

1710

63.7%

No

437

16.3%

Yes

2246

83.7%

No

1122

41.8%

Yes

1561

58.2%

Personal history of cardiovascular disease

1925 of the patients (71.7%) were having history of coronary disease (angina pectoris,
myocardial infarction etc), 512 patients (19.1%) history of cerebrovascular disease (stroke, TIA,
carotid stenosis etc) and 887 of them (33.1%) history of peripheral arterial disease.
Clinical data at baseline
Mean weight was 83.32 kg (85.93 kg in the male group and 77.96 kg in the female one), mean
height 170.31 cm (173.86 cm in the male group and 163 cm in the female one) and mean waist
98.27 cm (99.38 cm in the male group, respective 95.94 cm in the female one).
Clinical data

SBP

Valid

DBP Heart rate

2671 2670

2652

N
Missing
Mean value

12

13

31

144.72 84.23

75.81

Diagnosis of the coronary disease

1730 of the patients (64.48%) were diagnosed with angina pectoris and 953 of them
(35.52%) with myocardial infarction. Mean history of the disease was 2.97 years.
Ankle-Brachial Index (ABI) measurement
ABI measurement Frequency Percent

ABI 0.9

865

32.2%

ABI < 0.9

1790

66.7%

Total

2655

99.0%

28

1.0%

Missing
Total

2683 100.0%

Risk of major cardiovascular events based on ABI values

ABI classification Frequency Percent
ABI > 1.4

0.2%

859

32.0%

ABI < 0.9

1790

66.7%

Total

2655

99.0%

Missing

28

1.0%

1.4 ABI 0.9

Total

2683 100.0%

Antiplatelet therapy recommended at baseline

Therapeutic class

Frequency Percent

Acetylsalicylic acid + Thienopyridine

1831

68.2%

Thienopyridine

583

21.7%

Acetylsalicylic acid

127

4.7%

Acetylsalicylic acid + Thienopyridine + Others

66

2.5%

No treatment

30

1.1%

Thienopyridine + Others

21

0.8%

Acetylsalicylic acid + Others

20

0.7%

0.2%

Others
Total

2683 100.0%

Major cardiovascular events occurred during the 6 months of follow up

Cardiovascular events
Count Column N %
Vascular death

Myocardial infarction

Stroke / TIA

No
Yes
No
Yes
No
Yes

2675

99.7%

0.3%

2659

99.1%

24

0.9%

2636

98.2%

47

1.8%

72% 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
28% in those with normal ABI values.

Conclusions:
The prevalence of Peripheral Arterial Disease (PAD) based on ABI measurement in the cohort
of 2683 patients admitted to hospital with diagnostic of ACS or outpatients after an ACS (within
last 6 months), ambulatory checked was of 67.4% (1790 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 (0.2%)
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):
Odds Ratio (95%CI)

Risk Ratio (95%CI)

X2

p-value

Hypertension

1.32 (1.07-1.61)

1.09 (1.02-1.19)

7.08

0.007

Diabetes mellitus

1.81 (1.51-2.17)

1.19 (1.13-1.25)

42.04

0.00001

Smoking

1.35 (1.13-1.6)

1.1 (1.04-1.16)

11.51

0.0006

Dyslipemia

0.9 (0.7-1.14)

0.97 (0.91-1.04)

0.69

0.405

1.23 (1.04-1.46)

1.07 (1.01-1.13)

5.93

0.01

Risk factors

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.
72% 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
28% in those with normal ABI values.
98.9% of the patients were on antiplatelet treatment at the inclusion visit: 76.2% acetylsalicylic
acid, 93.2% thienopyridine and 4.2% others, as monotherapy or in combinations.

Date of report: .............

.-

.- 2014......................................