CLINICAL STUDY REPORTStudy Title

PREvalence of peripheral arterial disease in acute coronary Syndrome patiENTs

Investigator(s): Pistea Maria-Madalina, seria II, grupa 15Data set: 2064Objectives:

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 studyNumber of patients/subjects: 100Evaluated:

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 75% male and 25% female and with mean age of 63.86 years (63.5 years in male group , respective 64.92 years in female one).Cardiovascular risk factorsCardiovascular risk factorsCountColumn N%

HypertensionNo2323%

Yes7777%

Diabetes miellitusNo6767%

Yes3333%

Smoking / History of smokingNo3131%

Yes6969%

DyslipemiaNo1919%

Yes8181%

Family history of cardiovascular diseaseNo4848%

Yes5252%

Personal history of cardiovascular disease 73 of the patients (73%) were having history of coronary disease (angina pectoris,

myocardial infarction etc), 21 patients (21%) history of cerebrovascular disease (stroke, TIA,carotid stenosis etc) and 36 of them (36%) history of peripheral arterial disease.

Clinical data at baselineMean weight was 81.91 kg (84.08 kg in the male group and 75.4 kg in the female one), mean height 170.33 cm (173.12 cm in the male group and 161.96 cm in the female one) and mean waist 98.49 cm (100.08 cm in the male group, respective 93,79 cm in the female one).

Clinical dataSBPDBPHeart rate

NValid10010099

Missing001

Mean value143.3683.6475.20

Diagnosis of the coronary disease37 of the patients (37 %) were diagnosed with angina pectoris and 22 of them ( 22%) with myocardial infarction. Ankle-Brachial Index (ABI) measurement

ABI measurementFrequencyPercent

NABI 0.093131%

ABI < 0.096868%

Total9999%

Missing11%

Total100100%

Risk of major cardiovascular events based on ABI values

ABI classificationFrequencyPercent

NABI > 1.400%

1.4 ABI 0.93131%

ABI < 0.96868%

Total9999%

Missing11%

Total100100%

Antiplatelet therapy recommended at baseline

Therapeutic classFrequency Percent

Acetylsalicylic acid +

Thienopyridine6464%

Thienopyridine2929%

Acetylsalicylic acid44%

Acetylsalicylic acid +

Thienopyridine + Others33%

No treatment00%

Thienopyridine + Others00%

Acetylsalicylic acid + Others00%

Others00%

Total100100%

Major cardiovascular events occurred during the 6 months of follow up

Cardiovascular eventsCountColumn N%

Vascular deathYes00%

No100100%

Myocardial infarctionYes11%

No9999%

Stroke/ TIAYes33%

No9797%

4% 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 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 68% ( 68 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 0 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 factorsOdd-ratio (95%CI)Risk-ratio(95%CI)X2uncorrectedX2usedp-value

Hypertension0.81 (0.30-2.18)0.95 (0.74-1.21)0.160.160.31

Diabetes mellitus0.83 (0.34-2.01)0.89 (0.51-1.56)0.160.150.35

Smoking0.37 (0.15-0.92)0.71 (0.50-1.01)4.714.670.018

Dyslipemia2.87 (0.77-10.70)1.18 (0.99-1.40)2.632.600.05

History CV disease0.69 (0.29-1.61)0.83 (0.53-1.29)0.720.720.20

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.

4% 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 0 % in those with normal ABI values.

100% of the patients were on antiplatelet treatment at the inclusion visit: 71% acetylsalicylic acid, 96 % thienopyridine and 3 % others, as monotherapy or in combinations.

Date of report: 5.01.2015

Date of report: 5.01.2015