CLINICAL STUDY REPORT

Study Title
PREvalence of peripheral arterial disease in acute coronary Syndrome
patiENTs
Investigator: Mocanu Diana-Alexandra (seria 8, grupa 72)
Data set: Esant8071.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
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,
personalhistory 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: 72% male and
28% female and with mean age of 63,30 years (63,04 years in male group, respective 63,96
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 %

19
81
62
38
29
71
12
88
45
55

19,00%
81,00%
62,00%
62,00%
29,00%
71,00%
12,00%
88,00%
45,00%
55,00%

Personal history of cardiovascular disease

68 of the patients (68,00%) were having history of coronary disease (angina pectoris,
myocardial infarction etc), 17 patients (17,00%) history of cerebrovascular disease (stroke,
TIA, carotid stenosis etc) and 33 of them (33,00%) history of peripheral arterial disease.
Clinical data at baseline
Mean weight was 84,67 kg (88,02 kg in the male group and 76,03 kg in the female one),
mean height 171,26 cm (174,62 cm in the male group and 162,60 cm in the female one) and
mean waist 99,12 cm (100,40 cm in the male group, respective 95,85 cm in the female one).
Clinical data
N

SBP

DBP

Heart rate

Valid

98

98

99

Missing

139,21

80,69

73,57

Mean value

Diagnosis of the coronary disease

59 of the patients ( 59,00%) were diagnosed with angina pectoris and 41 of them
(41,00 %) with myocardial infarction. Mean history of the disease was 6,68 years.
Ankle-Brachial Index (ABI) measurement
ABI measurement
Frequency
Percent
ABI 0.9

27

27,00%

ABI < 0.9

71

71,00%

Total

98

98,00%

Missing

2,00%

Total

100

100.0%

Risk of major cardiovascular events based on ABI values

ABI classification
Frequency
Percent
ABI > 1.4

0%

1.4 ABI 0.9

27

27%

ABI < 0.9

71

71,00%

Total

98

98,00%

Missing

2,00%

Total

100

100.0%

Antiplatelet therapy recommended at baseline

Therapeutic class

Frequency

Percent

Acetylsalicylic acid +
Thienopyridine

75

75,00%

Thienopyridine

18

18,00%

Acetylsalicylic acid

2,00%

Acetylsalicylic acid +
Thienopyridine + Others

4,00%

No treatment

1,00%

Thienopyridine + Others

0,00%

Acetylsalicylic acid + Others

0,00%

Others

0,00%

Total

100

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

100

100%

Yes

0%

No

98%

98%

Yes

2%

No

99%

99%

Yes

1%

33% 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 66% 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 71% ( 71 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%CI)

Risk Ratio (95%CI)

X2
uncorrected

X2
used

Hypertension

2,2967 (0,8063-6,5416)

1,2009 (0,9220-1,5641)

2,5013

1,678
5

0,195

Diabetes mellitus

1,3023 (0,5133-3,3041)

1,1831 (0,6452-2,1695)

0,3101

0,104
7

0,746

Smoking

2,0243 (0,7943-5,1591)

1,2597 (0,8958-1,7713)

2,2233

1,546
1

0,213

Dyslipemia

0,8611 (0,2147-3,4539)

0,9824 (0,8370-1,1530)

0,0446

0,017
9

0,893

History CV disease

1,3896 (0,5714-3,3796)

1,1701 (0,7523-1,8200)

0,5283

0,250
0

0,617

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.
33% 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 66% in those with normal ABI values.
99% of the patients were on antiplatelet treatment at the inclusion visit: 81%
acetylsalicylicacid, 97% thienopyridine and 4% others, as monotherapy or in combinations.
Date of report: 26.03.2015

p-value