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, non-
interventional 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
No 549 20.5%
Yes 2134 79.5%
Diabetes mellitus
No 1694 63.1%
Yes 989 36.9%
Smoking / History of smoking
No 973 36.3%
Yes 1710 63.7%
Dyslipemia
No 437 16.3%
Yes 2246 83.7%
Family history of cardiovascular disease
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 DBP Heart rate
N
Valid 2671 2670 2652
Missing 12 13 31
Mean value 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
N
ABI 0.9 865 32.2%
ABI < 0.9 1790 66.7%
Total 2655 99.0%
Missing 28 1.0%
Total 2683 100.0%

Risk of major cardiovascular events based on ABI values
ABI classification Frequency Percent
N
ABI > 1.4 6 0.2%
1.4 ABI 0.9 859 32.0%
ABI < 0.9 1790 66.7%
Total 2655 99.0%
Missing 28 1.0%
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%
Others 5 0.2%
Total 2683 100.0%

Major cardiovascular events occurred during the 6 months of follow up
Cardiovascular events Count Column N %
Vascular death
No 2675 99.7%
Yes 8 0.3%
Myocardial infarction
No 2659 99.1%
Yes 24 0.9%
Stroke / TIA
No 2636 98.2%
Yes 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):

Risk factors Odds Ratio (95%CI) Risk Ratio (95%CI) X
2
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
History CV disease 1.23 (1.04-1.46) 1.07 (1.01-1.13) 5.93 0.01

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......................................