CLINICAL STUDY REPORT

Study Title

PREvalence of peripheral arterial disease in acute coronary Syndrome patiENTs

Investigator(s): ....RADU A.B. ANA (VII, 61) ..............

Data set: 7041

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, non-

interventional study

Number of patients/subjects: 100

Evaluated:
ABI (Cut-off for PAD 0,9)
Epidemiological data:
 atherothromotic 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 recommended at baseline.
Summary:

Population studied: 100 patients, with the following gender distribution: 64 % male and 36 %
female with mean age of 65.23 years ( 62.81 years in male group, respective 69.53 years in
female one).

Cardiovascular risk factors

Cardiovascular risk factors Count Column N%
No 20 20 %
Hypertension
Yes 80 80 %
No 71 71 %
Diabetes mellitus
Yes 29 29 %
No 38 38 %
Smoking / History of smoking
Yes 62 62 %
No 15 15 %
Dyslipemia
Yes 85 85 %
No 46 46 %
Family history of cardiovascular disease
Yes 54 54 %

Personal history of cardiovascular disease

67 of the patients ( 67 %) were having history of coronary disease (angina pectoris, miocardial
infarction etc), 23 of the patients ( 23 %) history of cerebrovascular disease (stroke,TIA,
carotid stenosis etc), and 32 of them ( 32 %) history of peripheral arterial disease.

Clinical data at baseline

Mean weight was 81.99 kg ( 84.00 kg in the male group and 78.42 kg in the female one),
mean height was 169.78 cm ( 173.39 cm in the male group and 163.36 cm in the female one)
and mean waist 96.54cm ( 96.00 cm in the male group and 97.50 cm in the female one).

Clinical data SBP DBP Heart rate

Valid 100 100 100

N
Missing 0 0 0
Mean Value 144.03 83.67 76.2

Diagnosis of the coronary disease

68 of the patients ( 68%) were diagnosed with angina pectoris and 32 of them ( 32%) with
myocardial infarction. Mean history of the disease was 4.39 years.

Ankle-Brachial Index (ABI) measurement

ABI measurement Frequency Percent
ABI ≥ 0.9 30 30%
N ABI < 0.9 70 70%
Total 100 100%
Missing 0 0%
Total 100 100%
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 70 70%
Total 100 100%
Missing 0 0%
Total 100 100%

Antiplatelet therapy recommended at baseline

Therapeutic class Frequency Percent
Acetylsalicylic acid +
69 69%
Thienopyridine
Thienopyridine 14 14%

Acetylsalicylic acid 7 7%
Acetylsalicylic acid +
6 6%
Thienopyridine + Others
No treatement 1 1%

Thienopyridine + Others 3 3%

Acetylsalicylic acid + Others 0 0%

Others 0 0%

Total 100 100%

Major cardiovascular events occurred during the 6 months of follow up

Cardiovascular events Count Column N%
No 99 99 %
Vascular death
Yes 1 1%
No 99 99 %
Myocardial infarction
Yes 1 1%
No 100 100 %
Stroke / TIA
Yes 0 0%

100% of the major cardiovascular events (vascular death, myocardial infarction and
stroke/TIA) occured 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 moths), ambulatory checked was of 70% (70 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 where the following risk factors: hypertention, diabetes mellitus, present smoking or
history of smoking and history of cardiovascular diseases (p values of statistical sighificance
are illustrated bellow):

Risk factors Odds Ratio (95%CI) Risk Ratio (95%CI) X2 X2 p-value

uncorr used
Hypertension 2.03 (0.74 – 5.54) 1.29 (0.85 – 1.97) 1.94 1.26 0.1992

Diabetes 1.34 (0.52 – 3.47) 1.23 (0.61 – 2.48) 0.36 0.13 0.9867
mellitus
Smoking 0.26 (0.09 – 0.71) 0.65 (0.49 – 0.86) 7.40 6.25 0.0171

Dyslipemia 0.48 (0.12 – 0.85) 0.91 (0.77 – 1.06) 1.17 0.61 0.5566

History CV 0.60 (0.25 – 0.42) 0.80 (0.56 – 1.14) 1.37 0.91 0.2204
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
Pepheral Arterial Disease induction.

100% of the major cardiovascular events (vascular death, myocardial infarction and
stroke/TIA) occured 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.

99% of the patients were on antiplatelet treatement at the inclussion visit: 82% acetylsalicylic
acid, 92% thienopyridine and 9% others, as monotherapy or in combinations.

Date of report: ........ 08.-01.-2018............