CLINICAL STUDY REPORT

Study Title

PREvalence of peripheral arterial disease in acute coronary Syndrome patients

Investigator: Saly Catalin Vasile (seria 7, grupa 64)

Data set: Esant7077

Objectives:
Primary:
 To evaluate the prevelance of Peripheral Arterial Disease (PAD) in patients admitted in
hospital with diagnosis of ACS or ourpatients after an ACS (within lost 5 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

Metodology: open-label, non-radomized, national, multicentric, prospective, non-

international 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 ater an ACS (within lost 6 monts), ambulatory
cheked; informed consent signed
 Exclusion Criteria; patients < 40years; patients who did not sign the informed consent
form: patients enrolled in other studies

Criteria for evaluation:

Will be collected; demogephic data of patient, cardiovascular risk factors, personal
history of cardiovascular diseas, clinical data, diagnosisof coronary diseas, Ankle-Brachial
Index(ABI), antiplatelet treatment recommended at baseline.
Summary:

Population studied: 100 patients, with the following gonder distribution: 59% male and 41%
female and with mean age of 64.61 years (64.02 years in male group, respective 65.44 years in
female one).

Cardiovascular risk factors

Cardiovascular risk factors Count Column N%
No 21 21%
Hypertension
Yes 79 79%
No 59 59%
Diabetes mellitus
Yes 41 41%
No 43 43%
Smoking / History of smoking
Yes 57 57%
No 14 14%
Dyslipemia
Yes 86 86%
No 40 40%
Family history of cardiovascular disease
Yes 60 60%

Personal history of cardiovascular disease

74 of the patients (74%) were having history of coronary disease (angina pectoris, myocardial
infarction etc.) 24 patients (24% history of cerebrovascular disease (stroke, TIA, carotid stenosis
etc.) and 37 of them (37%) history of peripheral arterial disease.

Clinical data at baseline

Mean weight was 82.58kg ( 86.54kg in the male group and 76.88kg in the female one), mean
height 169.64cm (174.15cm in the male group and 163.15cm in the female one) and mean
waist 100.30cm (102.47cm in the male group, respective 97.00cm in the female one).
Clinical data SBP DBP Heart rate
Valid 100 100 97
N
Missing 0 0 3
Mean value 143.99 83.08 73.12

Diagnosis of the coronary disease

65 of the patients (65%) were diagnosed with angina pectoris and 35 of them (35%) with
myocardial infarction. Mean history of the disease was 3.49 years.

Ankle-Brachial Index (ABI) measurement

ABI measurement Frequency Percent
ABI≥0,9 28 29%
N ABI<0,9 71 71%
Total 99 99%
Missing 1 1%
Total 100 100%
Risk of major cardiovascular events based on ABI values
ABI calsification Frequency Percent
ABI≥1,4 0 0%
1,4≥ABI≥0,9 28 28%
N
ABI<0,9 71 71%
Total 99 99%
Missing 1 1%
Total 100 100%

Antiplatelet therapy recommended at baseline

Therapeutic class Frequency Percent
Acetyl salicylic acid +
Thienopyridine 70 70%

Thienopyridine 19 19%

Acetyl salicylic acid 4 4%

Acetyl salicylic acid +
Thienopyridine+Others 3 3%

No treatment 3 3%
Thienopyridine+Others 1 1%

Acetyl salicylic acid +Others 0 0%

Others 0 0%
Total 100 100%

Major cardiovascular events occurred during the 6 months of fallow up

Cardiovascular events Count Column N %
No 99 99%
Vascular death
Yes 1 1%
No 99 99%
Myocardial infection
Yes 0 0%
No 95 95%
Stroke / TIA
Yes 5 5%

83.33% 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 16.67% 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
lost 6 months), ambulatory cheked was of 71 (71% patients with ABI values <0,9). ABI
measurement is also considered as a geralized atherosclerotic marker that may alow
identifying patients at high risk for developing cardio or cerebrovascular events: on top of the
patients with ABI value lower than 0,9 there were those ones with ABI values > 1,4 (0%)
indicating arterial stiffness and, as already mentioned, risk 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: hipertensions, diabetes mellitys, present smoking or
history of smoking and history of cardiovascular diseases (p values of statistical significance are
illustrated below):

Risk factors Odds Ratio (95%Cl) Risk Ratio (95%Cl) X² used p-value
Hypertension 1.97(0.70-5.50) 1.24(0.85-1.82) 1.69 0.192
Diabetes mellitus 4.73(1.62-13.84) 1.46(1.15-1.85) 8.92 0.002
Smoking 2.67(1.09-6.57) 1.33(1.01-1.75) 4.74 0.02
Dyslipemia 1.01(0.29-3.56) 1.04(0.73-1.49) 0.0007 0.97
History CV disease 1.73(0.71-4.19) 1.17(0.90-1.53) 1.49 0.22

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.

83.33% 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 of ABI values <
0,9 and only 16.67% in those with normal ABI values.

97% of the patients were on antiplatelet treatment as the inclusion visit: 77% acetylsalicylic
acid, 93% thienopyridine and 4% others, as monotherapy or in combinations.

Date of report:
Istoric boli vasculare periferice

Istoric boli cerebrovasculare

Istoric boli coronare

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Distributie pe sexe
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