CLINICAL STUDY REPORT

Study Title Prevalence of peripheral arterial disease in Acute Coronary Syndrome patients Investigator: .....LIXANDRU BIANCA (2, 22)........................................ Data set: ESANT8 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, noninterventional 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: 70% male and 30% female and with mean age of 63.27 years (65.26 years in male group, respective 62.41 years in female one). Cardiovascular risk factors No Hypertension Yes No Diabetes mellitus Yes No Smoking/ History of smoking Yes No Dyslipemia Yes No Family history of cardiovascular disease Yes Count 18 82 64 36 30 70 19 81 35 65 Column N % 18 % 82% 64% 36% 30% 70% 19% 81% 35% 65%

Personal history of cardiovascular disease 70 of the patients ( 70%) were having history of coronary disease (angina pectoris, myocardial infarction etc), 23 patients ( 23%) 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 84.68 kg ( 88.20 kg in the male group and 76.46kg in the female one), mean height 170.71 cm ( 174.50 cm in the male group and 161.86 cm in the female one) and mean waist 96.44cm ( 98.24 cm in the male group, respective 92.34 cm in the female one)

Clinical data Valid N Missing Mean value

SBP 98 2 144.12

DBP 98 2 84.63

Heart rate 97 3 73.94

Diagnosis of the coronary disease 28 of the patients ( 28%) were diagnosed with angina pectoris and 29 of them ( 29%) with myocardial infarction. Mean history of the disease was 4.72 years. Ankle-Brachial Index (ABI) measurement ABI measurement ABI 0.9 N ABI < 0.9 Total Missing Total Frequency 31 67 98 2 100 Percent 31% 67% 98% 2% 100.0 %

Risk of major cardiovascular events based on ABI values ABI classification ABI > 1.4 1,4 ABI 0.9 N ABI < 0.9 Total Missing Total 67 98 2 100 67% 98% 2% 100.0 Frequency 0 31 Percent 0% 31%

Antiplatelet therapy recommended at baseline Terapeutic class Acetylsalicylic acid + Thienopyridine Thienopyridine Acetylsalicylic acid Acetylsalicylic acid + Thienopyridine + Others No treatment Thienopyridine + Others Acetylsalicylic acid + Others Others Total Frequency 60 Percent 60%

29 2 6

29% 2% 6%

0 1 1 1 100

0% 1% 1% 1% 100.0%

Major cardiovascular events occurred during the 6 months of follow up Cardiovascular events Vascular death No Yes No Yes No Yes Count 100 0 99 1 99 1 Column N % 100% 0% 99% 1% 99% 1%

Myocardial infarction

Stroke/ TIA

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 7 % ( 67 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 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): Risk factors Hypertension Diabetes mellitus Smoking Dyslipemia History CV disease Odds ratio (95%CI) Risk ratio (95%CI) X2 p-value

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. ...% 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...% in those with normal ABI values. ...% of the patients were on antiplatelet treatment at the inclusion visit: % acetylsalicylic acid, ...% thienopyridine and ...% others, as monotherapy or in combinations.

Date of report: ............. 15- 01- 2014.............