CLINICAL STUDY REPORT

Study Title

PREvalence of peripheral arterial disease in acute coronary Syndrome patiENTs

Investigator(s): POP HOREA(seria 7, grupa 65 )

Data set: 7074

Objectives:
Primary:

To evaluate the prevalence of Peripheral Arterial Disease (PAD) in patients admitted

in hospital with diagnosis of ACS or outpatients afer 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, non-

interventional study

Number of patients/subjects: 100

Evaluated:
ABI (Cut-off PAD 0.9)
Epidemiological data:

atherothrombic 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: 100 patients, with the following gender distribution: 61% male and 39%
female and with mean age of 63.52 years (61.85 years in male group, respective 66.12 years
in female one).

Cardiovascular risk factors

Cardiovascular risk factors

Count Column N%

No 24 24%
Hypertension
Yes 76 76%

No 53 53%
Diabetes mellitus
Yes 47 47%

No 29 29%
Smoking/ History of smoking
Yes 71 71%

No 18 18%
Dyslipemia
Yes 82 82%

No 44 44%
Family history of cardiovascular
disease
Yes 56 56%

Personal history of cardiovascular disease

69 of the patients (69%) were having history of coronary disease (angina pectoris,
myocardial infarction etc), 21 patients (21%) history of cerebrovascular disease (stroke, TIA,
carotid stenosis etc) and 31 of them (31%) history of peripheral arterial disease.

Clinical data at baseline

Mean weight was 82.55 kg (86.24 kg in the male group and 76.76 kg in the female one),
mean height 170.21 cm (175.55 cm in the male group and 161.84 cm in the female one) and
mean waist 96.81 cm (97.08 cm in the male group, respective 96.34 cm in the female one).

Clinical data SBP DBP Heart rate

Valid 99 99 98
N
Missing 1 1 2
Mean value 142.9 84.05 74.16

Diagnosis of the coronary disease

28 of the patients (28%) were diagnosed with angina pectoris and 28 of them (28%) with
myocardial infarction. Mean history of the disease was 3.29 years.
Ankle-Brachial Index (ABI) measurement

ABI Frequenc Percent

measurement y
ABI 0.9 30 30%
N ABI < 0.9 68 68%
Total 98 98%
Missing 2 2%

Total 100 100.0%

Risk of major cardiovascular events based on ABI values

ABI classification Frequency Percent

ABI > 1.4 0 0%
1.4 ABI 0.9 30 30%
N ABI < 0.9 68 68%
Total 98 98%

Missing 2 2%
Total 100 100.00%

Antiplatelet therapy recommended at baseline

Therapeutic class Frequency Percent

Acetylsalicylic acid + 68 68%
Thienopyridine
Thienopyridine 21 21%
Acetylsalicylic acid 4 4%
Acetylsalicylic acid + 2 2%
Thienopyridine + Others
No treatment 0 0%
Thienopyridine + Others 1 1%
Acetylsalicylic acid + Others 4 4%
Others 0 0%
Total 100 100%

Major cardiovascular events occured during the 6 months of follow up

Cardiovascular events Count Column N%

Vascular death No 100 100%

Yes 0 0%
Myocardial infarction No 99 99%

Yes 2 2%
Stroke/ TIA No 100 100%
Yes 0 0%
0% 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 1% 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 Odds Ratio (95%CI) Risk Ratio (95% x2 x2 p-value

CI)
uncorrected used
Hypertension 0.68 (0.24- 1.92) 0.89 (0.67-1.18) 0.53 0.22 0.6341
Diabetes 0.52 (0.22-1.23) 0.81 (0.62-1.07) 2.20 1.61 0.2043
mellitus
Smoking 0.48 (0.17-1.33) 0.81 (0.63-1.05) 2.02 1.40 0.2354
Dyslipemia 0.38 (0.10-1.44) 0.79 (0.61-1.02) 2.10 1.37 0.2417
History CV 0.39 (0.16-0.98) 0.76 (0.58-0.98) 4.08 3.25 0.071
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.

0% 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 1% in those with normal ABI values.

100% of the patients were on antiplatelet treatment at the inclusion visit: 4% acetylsalicylic
acid, 21% thienopyridine and 74% others, as monotherapy or in combinations.

Date of report: 25.05.2017

 Heart rate distribution/sex
75.5

75

74.5

74

73.5

73

72.5

72
1
History of coronary disease

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