CLINICAL STUDY REPORT

Study Title PREvalence of peripheral arterial disease in acute coronary Syndrome patiENTs Investigator(s): ..... POPESCU Ion (XX, 222) ........................................ Data set: 101 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: 2683 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: 2683 patients, with the following gender distribution: 67.3% male and 32.7% female and with mean age of 63.75 years (65.95 years in male group, respective 65.37 years in female one). Cardiovascular risk factors Cardiovascular risk factors Hypertension No Yes No Yes No Yes No Yes No Yes

Count Column N % 549 2134 1694 989 973 1710 437 2246 1122 1561 20.5% 79.5% 63.1% 36.9% 36.3% 63.7% 16.3% 83.7% 41.8% 58.2%

Diabetes mellitus

Smoking / History of smoking

Dyslipemia

Family history of cardiovascular disease

Personal history of cardiovascular disease 1925 of the patients (71.7%) were having history of coronary disease (angina pectoris, myocardial infarction etc), 512 patients (19.1%) history of cerebrovascular disease (stroke, TIA, carotid stenosis etc) and 887 of them (33.1%) history of peripheral arterial disease. Clinical data at baseline Mean weight was 83.32 kg (85.93 kg in the male group and 77.96 kg in the female one), mean height 170.31 cm (173.86 cm in the male group and 163 cm in the female one) and mean waist 98.27 cm (99.38 cm in the male group, respective 95.94 cm in the female one). Clinical data Valid N Missing Mean value 12 13 31 75.81 144.72 84.23 SBP DBP Heart rate 2652

2671 2670

Diagnosis of the coronary disease 1730 of the patients (64.48%) were diagnosed with angina pectoris and 953 of them (35.52%) with myocardial infarction. Mean history of the disease was 2.97 years. Ankle-Brachial Index (ABI) measurement ABI measurement Frequency Percent ABI 0.9 N ABI < 0.9 Total Missing Total 865 1790 2655 28 32.2% 66.7% 99.0% 1.0%

2683 100.0%

Risk of major cardiovascular events based on ABI values ABI classification Frequency Percent ABI > 1.4 N 1.4 ABI 0.9 ABI < 0.9 Total Missing Total 6 859 1790 2655 28 0.2% 32.0% 66.7% 99.0% 1.0%

2683 100.0%

Antiplatelet therapy recommended at baseline Therapeutic class Acetylsalicylic acid + Thienopyridine Thienopyridine Acetylsalicylic acid Acetylsalicylic acid + Thienopyridine + Others No treatment Thienopyridine + Others Acetylsalicylic acid + Others Others Total Frequency Percent 1831 583 127 66 30 21 20 5 68.2% 21.7% 4.7% 2.5% 1.1% 0.8% 0.7% 0.2%

2683 100.0%

Major cardiovascular events occurred during the 6 months of follow up Cardiovascular events Count Column N % Vascular death No Yes No Yes No Yes 2675 8 2659 24 2636 47 99.7% 0.3% 99.1% 0.9% 98.2% 1.8%

Myocardial infarction

Stroke / TIA

72% 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 28% in those with normal ABI values.

Conclusions:
The prevalence of Peripheral Arterial Disease (PAD) based on ABI measurement in the cohort of 2683 patients admitted to hospital with diagnostic of ACS or outpatients after an ACS (within last 6 months), ambulatory checked was of 67.4% (1790 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 (0.2%) 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 Hypertension Diabetes mellitus Smoking Dyslipemia History CV disease Odds Ratio (95%CI) 1.32 (1.07-1.61) 1.81 (1.51-2.17) 1.35 (1.13-1.6) 0.9 (0.7-1.14) 1.23 (1.04-1.46) Risk Ratio (95%CI) 1.09 (1.02-1.19) 1.19 (1.13-1.25) 1.1 (1.04-1.16) 0.97 (0.91-1.04) 1.07 (1.01-1.13) X2 7.08 42.04 11.51 0.69 5.93 p-value 0.007 0.00001 0.0006 0.405 0.01

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. 72% 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 28% in those with normal ABI values. 98.9% of the patients were on antiplatelet treatment at the inclusion visit: 76.2% acetylsalicylic acid, 93.2% thienopyridine and 4.2% others, as monotherapy or in combinations.

Date of report: .............

.-

.- 2014......................................