CLINICAL STUDY REPORT

Study Title

Prevalence of peripheral arterial disease in acute coronary syndrome patients

Investigator: Laura Marin ( I,10)

Data set: 1119

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:
 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: 66 % male and 34 % female
and with mean age of 63.02 years (63.00 years in male group, respective 63.05 years in female one).

Cardiovascular risk factors

Cardiovascular risk factors Count Column N %
No 26 26%
Hypertension
Yes 74 74%
No 55 55%
Diabetes mellitus
Yes 45 45%
No 40 40%
Smoking / History of smoking
Yes 60 60%
No 13 13%
Dyslipidemia
Yes 87 87%
No 42 42%
Family history of cardiovascular disease
Yes 58 58%

Personal history of cardiovascular disease

82 of the patients (82 %) were having history of coronary disease (angina pectoris, myocardial infarction
etc), 18 patients (18 %) history of cerebrovascular disease (stroke, TIA, carotid stenosis etc) and 35 of
them (35 %) history of peripheral arterial disease.

Clinical data at baseline

Mean weight was 85.68 kg (88.30 kg in the male group and 80.51kg in the female one), mean height
170.74 cm (174.15 cm in the male group and 164.03 cm in the female one) and mean waist 98.47 cm
(100.65 cm in the male group, respective 94.06 cm in the female one).

Clinical data SBP DBP Heart rate

Valid 100 100 100

N
Missing 0 0 0

Mean value 143.45 84.21 75.89

Diagnosis of the coronary disease

27 of the patients (27%) were diagnosed with angina pectoris and 38 of them (38%) with myocardial
infarction. Mean history of the disease was 3,95 years.

Ankle-Brachial Index (ABI) measurement

ABI measurement Frequency Percent
ABI ≥ 0.9 26 26%
N ABI < 0.9 73 73%
Total 99 99%
Missing 1 1%
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 26 26%
N
ABI < 0.9 73 73%
Total 99 99%
Missing 1 1%
Total 100 100%

Antiplatelet therapy recommended at baseline

Therapeutic class Frequency Percent
Acetylsalicylic acid +
63 63%
Thienopyridine
Thienopyridine 31 31%
Acetylsalicylic acid 3 3%
Acetylsalicylic acid +
1 1%
Thienopyridine + Others
No treatment 2 2%

Thienopyridine + Others 0 0%
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 100 100%
Vascular death
Yes 0 0%
No 99 99%
Myocardial infarction
Yes 1 1%
No 97 97%
Stroke / TIA
Yes 3 3%

3% 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 73 % (73 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 Ratio X2 X2
Risk factors Odds Ratio (95%CI) p-value
(95%CI) uncorrected corrected
Hypertension 1.22 (0.48 – 3.09) 1.07 (0.76 – 1.51) 0.185 0.036 0.8483
Diabetes mellitus 0.67 (0.29 – 1.53) 0.86 (0.64 – 1.16) 0.899 0.543 0.4608
Smoking 1.00 (0.43 – 2.31) 1.00 (0.74 – 1.34) 0.000 0.000 1.0000
Dyslipidemia 0.80 (0.22 – 2.82) 0.92 (0.62 – 1.37) 0.117 0.001 0.9751
History CV
1.05 (0.45 – 2.42) 1.01 (0.76 – 1.36) 0.016 0.000 1.0000
disease

The logistic regression calculation (taking into account all these risk factors simultaneously) identified
that hypertension, diabetes mellitus, present smoking or history of smoking, dyslipidemia as well as
history of cardiovascular disease are all risk factors with major impact on Peripheral Arterial Disease
induction.

3% 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.

92 % of the patients were on antiplatelet treatment at the inclusion visit:3 % acetylsalicylic acid, 31 %
thienopyridine and 58 % others, as monotherapy or in combinations.

Date of report: 06-06-2017