CLINICAL STUDY REPORT

Study Title

PREvalence of peripheral arterial disease in acute coronary Syndrome patients

Investigator(s): DITOIU Alexandru Constantin (6, 71)

Data set: 6057

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 62.90
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%
Dyslipemia
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 34 of them (34%) history of peripheral arterial disease.
Clinical data at baseline
Mean weight was 85.68 kg ( 88.30 kg in the male group and 80.51 kg in the female one), mean
height 170.74 cm ( 174.15 cm in the male group and 80.51 cm in the female one) and mean
waist 98.47 cm ( 100.65 cm in the male group, respective 164.03 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

2 of the patients (2%) were diagnosed with angina pectoris and 3 of them
(3%) with myocardial infarction. Mean history of the disease was 68.00 years.

Ankle-Brachial Index (ABI) measurement

ABI measurement Frequency Percent
ABI≥0.9 73 73,00%
ABI≤0.9 26 26,00%
N
Total 99 99%
Missing 1 1%
Total 100 100%
Risk of major cardiovascular events based on ABI values
Frequenc
ABI classification Percent
y
ABI>1.4 75 75.76%
1.4≥ABI≥0.9 23 23.23%
N ABI≤0.9 1 1.01%
Total 99 99%
Missing 1 1%
Total 100 100%

Antiplatelet therapy recommended at baseline

Frequenc
Therapeutic class Percent
y
Acetylsalicylic + Thienopyridine 63 63%
Thienopyridine 31 31%
Acetylsalicylic acid 3 3%
Acetylsalicylic acid + Thienopyridine + Others 1 1%
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 96 96%
Myocardial infraction Yes 4 4%
No 97 97%
Stroke / TIA yes 3 3%

26% 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
74% 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 26.% (26 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 ( 00.00%)
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% X2 X2 p-value

(95% CI) CI) uncorrected used
Hypertension 0.95 (0.34-2.62) 0.96(0.46-2.03) 0.0079 0.0290 0.55
Diabetes mellitus 0.43(0.16-1.11) 0.53(0.25-1.10) 3.0670 2.3163 0.06
Smoking 0.89(0.36-2.22) 0.89(0.47-1.80) 0.0531 0.0000 0.49
Dyslipemia 0.51(0.15-1.72) 0.63(0.29-1.38) 1.1500 0.5392 0.22
History CV 0.41(0.52-3.28) 0.38
0.33(0.02-4.03) 0.7875
disease 0.1004

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.

1% 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
3% in those with normal ABI values.

98% of the patients were on antiplatelet treatment at the inclusion visit: 3% acetylsalicylic
acid, 31% thienopyridine and 64% others, as monotherapy or in combinations.

Date of report: 28 mai 2014

AP DE EFFORT - 1,
AP DE NOVO - 2,
AP AGRAVATA -3,
AP INSTABILA -4,
IMA - 5,
NSTEMI -6,
SD CORONARIAN AC -7,
CICD -8,
AP DE REPAOS -9