CLINICAL STUDY REPORT

Study Title

PREvalence of peripheral arterial disease in acute coronary Syndrome

patiENTs

Investigator: Meleandra Iuliana Alexandra (seria 7, grupa 61)

Data set: Esant7026.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: 70% male and
40% female and with mean age of 63,03 years (62,7571 years in male group, respective
63,6667 years in female one).

Cardiovascular risk factors

Cardiovascular risk factors Count Column N %
No 18 18%
Hypertension
Yes 82 82%
No 62 62%
Diabetes mellitus
Yes 38 38%
No 24 24%
Smoking / History of smoking
Yes 76 76%
No 14 14%
Dyslipemia
Yes 86 86%
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 86,3300 kg (90,0143 kg in the male group and 77,7333 kg in the female
one), mean height 171,7900 cm (175,1143 cm in the male group and 164,0333 cm in the
female one) and mean waist 100,1771 cm (101,1791 cm in the male group, respective
97,8621 cm in the female one).
Clinical data SBP DBP Heart rate
Valid 99 99 99
N
Missing 1 1 1
Mean value 147,6162 85,070 76,6566
7

Diagnosis of the coronary disease

61 of the patients ( 61%) were diagnosed with angina pectoris and 39 of them
(39 %) with myocardial infarction. Mean history of the disease was 9.69 years.

Ankle-Brachial Index (ABI) measurement

ABI measurement Frequency Percent
ABI 0.9 30 30%
N ABI < 0.9 69 69%
Total 99 99%
Missing 1 1%
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 69 69%
Total 99 99%
Missing 1 1%
Total 100 100.0%

Antiplatelet therapy recommended at baseline

Therapeutic class Frequency Percent
Acetylsalicylic acid + 63 63%
Thienopyridine
Thienopyridine 25 25%
Acetylsalicylic acid 8 8%
Acetylsalicylic acid + 2 2%
Thienopyridine + Others
No treatment 1 1%
Thienopyridine + Others 1 1%
Acetylsalicylic acid + Others 0 0%
Others 0 0%
Total 100 100.0%

Major cardiovascular events occurred during the 6 months of follow up

Cardiovascular events Count Column N %
No 100 100%
Vascular death
Yes 0 0%
No 100 100%
Myocardial infarction
Yes 0 0%
No 98 98%
Stroke / TIA
Yes 2 2%

100% 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 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 months), ambulatory checked was of 69% ( 69 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 X2 p-value

uncorrected used
Hypertension 1,1875 (0,3993-3,5316) 1,0326 (0,8377-1,2728) 0,0957 0,0007 0,979
Diabetes mellitus 0,9070 (0,3770-2,1820) 0,9420 (0,5528-1,6054) 0,0475 0,0000 0,994
Smoking 4,0321 (1,5316-10,6148) 1,4834 (1,0671-2,0620) 8,5420 7,1156 0,007
Dyslipemia 0,9077 (0,2606-3,1617) 0,9866 (0,8318-1,1703) 0,0231 0,0261 0,871
History CV disease 0,8172 (0,3420-1,9525) 0,9179 (0,6393-1,3178) 0,2066 0,0547 0,815

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.

100% 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 0% in those with normal ABI values.

99% of the patients were on antiplatelet treatment at the inclusion visit: 73%
acetylsalicylicacid, 27% thienopyridine and 3% others, as monotherapy or in combinations.

Date of report: 22.05.2017