CLINICAL STUDY REPORT

Study Title

Prevalence of peripheral arterial disease in acute coronary Syndrome patients

Investigator : NECHITA MIRUNA (seria 5, grupa 49)

Data set: 5107
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 the 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 terapeutic 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, multicentic, prospective, non-

interventional study.

Number of patients/subjects: 100

Evaluated:
ABI (Cut-off for PAD 0,9)
Epidemiological data:
 atherothrombotic risk factors
 dardiovascular 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 colected: 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: 67% male and 33%
female and with mean age of 62.92 years (62.13 years in male group, respective 64.15 years in
female one).

Cardiovascular risk factors:

Cardiovascular risk factors Count Column N%

No 16 16 %
Hypertension
Yes 84 84 %
No 64 64 %
Diabetus mellitus
Yes 36 36 %
No 32 32 %
Smoking / History of smoking
Yes 68 38 %
No 13 13 %
Dyslipidemia
Yes 87 87 %
No 41 41 %
Family history of cardiovascular disease
Yes 59 59 %

Personal history of cardiovascular disease

71 of the patients (71%) were having history of coronary disease (angina pectoris, myocardial
infarction etc) 17 patients (17%) history of cerebrovascular disease (stroke, TIA, carotid stenosis
etc) and 36 of them (36%) history of peripheral arterial disease.

Clinical data at baseline

Mean weight was 83.29 kg ( 85.17 kg in the male group and 79.45 kg in the female one), mean
height 170.44 cm ( 173.35 cm in the male group and 164.51 cm in the female one) and mean
waist 96.71 cm ( 97.86 cm in the male group, respective 94.37 cm in the female one).

Heart
Clinical data SBP DBP
rate
Valid 99 99 99
N
Missing 1 1 1
Mean value 144.70 85.21 78.26

Diagnosis of the coronary disease

19 of the patients (19%) were diagnosed with angina pectoris and 32 of them ( 32%) with
myocardial infarction. Mean history of the disease was 10.7 years
Ankle-Brachial Index (ABI) measurement

ABI measurement Frequency Percent

ABI ≥ 0.9 27 27%
N ABI <0.9 71 71%
Total 98 98%
Missing 2 2%
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 27 27%
N
ABI<0.9 71 71%
TOTAL 98 98%
Missing 2 2%
Total 100 100%

Antiplatelet therapy recommended at baseline

Therapeutic class Frequency Percent

Acetylsalicylic acid +
70 70%
Thienopyridine
Thienopyridine 25 25%
Acetylsalicylic acid 3 3%
Acetylsalicylic acid +
0 0%
Thienopyridine + Others
No treatment 1 1%
Thienopyridine + Others 1 1%
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 99 99%
Stroke/TIA
Yes 1 1%

50% 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
50% in those with normal ABI values.

Conclusions:
The prevalence of Peripheral Arterial Disease (PAD) based on ABI measurements 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 71% ( 71 patients with ABI value < 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 one with ABI value > 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 where 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):

Odds Ratio Risk Ratio X2

Risk factors X2 used p-value
(95% CI) (95% CI) uncorrected
Hypertension 0.36 (0.11-1.12) 0.83 (0.65-1.05) 3.24 (0.071) 2.21 (0.13) 0.04(0.072)
Diabetes 0.53 0.65 1.55 1.02 0.11
mellitus (0.20-1.43) (0.32-1.32) (0.21) (0.31) (0.15)
Smoking 0.45 (0.18-1.14) 0.75 (0.52-1.09) 2.82 (0.092) 2.07 (0.15) 0.05 (0.07)
Dyslipidemia 0.83 (0.23-2.97) 0.97 (0.81-1.16) 0.077 (0.78) 0.003 (0.9) 0.38 (0.5)
History CV 0.70 0.85 0.61 0.30 0.22
disease (0.28-1.71) (0.56-1.28) (0.43) (0.58) (0.28)

The logistic regression calculation (taking into account all this risk factors simultaneously)
identified that hypertension, diabetes mellitus, present smoking or history of smoking,
dyslipidemia as well as history of cardiovascular diseases are all risk factors with major impact on
Peripheral Arterial Disease induction.
50% 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 value < 0.9 and only
50% in those with normal ABI values.
99% of the patients were on antiplatelet treatment at the inclusion visit: 73% acetylsalicylic acid,
96% thienopyridine and 1% others, as monotherapy or in combinations.
Date of report: 23-03-2019
 Smoking patients with a history of coronary disease

angina pectoris
16%

no vascular disease
31%

miocardial
infarction
32%
cicd
21%

History of cerebrovascular disease

14
12
10
8
6
4
2
0

tia cva cerebral infarctiom

cerebral lacune lacunar ictus carotic stenosis
vbci brain hemmorhage wallenberg sd