CLINICAL STUDY REPORT

Study Title

Prevalence of peripheral arterial disease in acute coronary Syndrome patients

Investigator(s): Claudia (Seria ,Grupa )

Data set:Esant 7094

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
thispopulation
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:
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: 100 patients, with the following gender distribution:59% male and
41% female and with mean age of 64.25 years (62.03 years in male group, respective 67.43
years in female one).

Cardiovascular risk factors

Cardiovascular risk factors Count Column N %
No 22 22%
Hypertension
Yes 78 75%
No 67 67%
Diabetes mellitus Yes 33 33%
Smoking/History of smoking No 41 41%
Yes 59 59%
Dyslipemia No 9 9%
Yes 91 91%
Family history of cardiovascular disease No 47 47%
Yes 53 53%

Personal history of cardiovascular disease

71 of the patients (71%) were having history of coronary disease (angina pectoris,
myocardial infarction etc),16 patients ( 16%) history of cerebrovascular disease (stroke,
TIA, carotid stenosis etc) and 33 of them (33%) history of peripheral arterial disease.

Clinical data at baseline

Mean weight was 81.13 kg ( 85.30 kg in the male group and 75.12 kg in the female one), mean
height 169.34 cm ( 173.57 cm in the male group and 163.24 cm in the female one) and mean
waist 96.45 cm ( 99.37 cm in the male group, respective 92.10 cm in the female one).
Clinical data SBP DBP Heart rate
Valid 99 99 96
N
Missing 1 1 4
Mean value 145.75 83.89 75.25

Diagnosis of the coronary disease

6 of the patients (65%) were diagnosed with angina pectoris and of them 35 (35%) with
myocardial infarction. Mean history of the disease was 3.74 years.

Ankle-Brachial Index (ABI) measurement

ABI measurement Frequency Percent
ABI 0.9 38 38%
N
ABI< 0.9 62 62%
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 1 1%

1.4 ABI 0.9 37 37%
N
ABI < 0.9 63 63%
Total 100 100%
Missing 0 0%
Total 100 100%

Antiplatelet therapy recommended at baseline

Therapeutic class Frequency Percent
Acetylsalicylic acid + 67 67%
Thienopyridine

Thienopyridine 19 19%

Acetylsalicylic acid 6 6%
Acetylsalicylic acid + 2 2%
Thienopyridine + Others
No treatment 3 3%
Thienopyridine + Others 2 2%
Acetylsalicylic acid + Others 2 2%
Others 0 0%

Total 100 100.0%

Major cardiovascular events occurred during the 6 months of follow up

Cardiovascular events Count Column N %

No 98 98%
Vascular death
Yes 2 2%
No 98 98%
Myocardial infarction
Yes 2 2%
No 100 100%
Stroke/TIA
Yes 0 0%

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 62% (63 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 ( 1%)
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 Risk Ratio (95%Cl) X2 X2 p-value

(95% Cl) uncorrected used
Hypertension 0.41(0.15-1.09) 0.61(0.37-1.00) 3.27 2.43 0.11

Diabetes 0.74(0.30-1.77) 0.82(0.47-1.45) 0.45 0.20 0.64

mellitus
Smoking 0.92(0.40-2.10) 0.95(0.57-1.58) 0.03 0.001 0.97

Dyslipemia 0.27(0.06-1.15) 0.52(0.30-0.90) 3.44 2.24 0.13

History CV 1.63(0.72-3.71) 1.35(0.80-2.28) 1.39 0.94 0.32
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.

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.

97% of the patients were on antiplatelet treatment at the inclusion visit: 77% acetylsalicylic
acid, 91% thienopyridine and 6% others, as monotherapy or in combinations.
 DG

DG
AP DE EFFORT - 1
AP DE NOVO - 2
AP AGRAVATA -3
AP INSTABILA -4
IMA - 5
NSTEMI -6
SD CORONARIAN AC -7
CICD -8

1 2 3 4 5 6 7 8

History of cerebrovascular
disease
15 120.00%
History of cerebrovascular 100.00%
disease 10 80.00%
60.00%
AIT - 1
5 40.00%
Inf Cerebral - 2
20.00%
0 0.00%
1 2

Frequency Cum Percent