Alexandra Vilceanu

7/25/2019 Alexandra Vilceanu

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CLINICAL STUDY REPORT

Study Title

Prevalence of peripheral arterial disease in acute coronary Syndrome patients

Investigator(s) !"l#eanu Ale$andra C%t%lina(Seria &'rua *+ )

Data set:Esant 3028

O,-e#tives

Pri.ary 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),amulatory chec!ed"

Se#ondary

To identify the #ain Clinical $ariales associated with a higher ris! of PAD among thispopulation

To evaluate the therapeutic management of these patients

To train Cardiologists to measure An!le % &rachial 'nde (A&') in order to improve diagnosis ofPAD

/et0odology openlael, nonrandomi*ed, national, multicentric, prospective, non

interventional study

Nu.,er o1 atients2su,-e#ts+

Evaluated

A&' (Cutoff for PAD ,-).pidemiological data/

atherothromotic ris! factors

cardiovascular previous events

treatments prescried at visit + (y therapeutic class)

Diagnosis and #riteria 1or in#lusion

'nclusion Criteria/ patients 0 1 years admitted in hospital with diagnosis of Acute

Coronary Syndrome or outpatients after an ACS (within last 6 months), amulatorychec!ed2 informed consent signed

.clusion Criteria/ patients 3 1 years2 patients who did not sign the informed consent form2 patients enrolled in other studies

Criteria 1or evaluation4ill e collected/ demographic data of the patient, cardiovascular ris! factors, personal

history of cardiovascular diseases, clinical data, diagnosis of coronary disease, An!le&rachial'nde (A&'), antiplatelet treatment recommended at aseline"


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Su..ary

Poulation studied/ + patients, with the following gender distriution/5 male and7 female and with mean age of 61"18 years (67"11 years in male group, respective 66"5years in female one)"

Cardiovas#ular ris3 1a#tors

Cardiovascular ris! factors Count Column 9

:ypertension

9o ** **4

;es +5 +54

Diaetes mellitus

9o 65 654

;es &* &*4

Smo!ing%:istory of smo!ing 9o &+ &+4

;es 6& 6&4

Dyslipemia 9o ** **4

;es +5 +54


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Total + +

Ris3 o1 .a-or #ardiovas#ular events ,ased on A:I values

A&'

classification

6>

Total -= -=

#issing 8 8

Total + +

Antilatelet t0eray re#o..ended at ,aseline

Therapeutic class >

Acetylsalicylic acid

Thienopyridine Bthers

8 8

9o treatment 7 7

Thienopyridine Bthers + +

Acetylsalicylic acid Bthers

Bthers

Total + +"

/a-or #ardiovas#ular events o##urred during t0e 6 .ont0s o1 1ollo; uCardiovascular events Count Column 9

$ascular death

9o -= -=

;es 8 8

#yocardial infarction

9o -- --

;es + +

Stro!e%T'A

9o -= -=

;es 8 8

6 of the maor cardiovascular events (vascular death, myocardial infarction and stro!e%T'A)occurred during the 6 months of follow up in the group of patients with A&' values 3 "- and only1 in those with normal A&' values"


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Con#lusions

The prevalence of Peripheral Arterial Disease (PAD) ased on A&' measurement in the cohortof + patients admitted to hospital with diagnostic of ACS or outpatients after an ACS (withinlast 6 months), amulatory chec!ed was of 6> (6> patients with A&' values 3 "-)" A&'

measurement is also considered as a generali*ed atherosclerotic mar!er that may allowidentifying patients at high ris! for developing cardio or cererovascular events/ on top of thepatients with A&' values lower than "- there were those ones with A&' values 0 +"1 ( )indicating arterial stiffness and, as already mentioned, ris! of maor cardiovascular events"

The main variales associated with a higher ris! of PAD that have een identified among thispopulation were the following ris! factors/ hypertension, diaetes mellitus, present smo!ing orhistory of smo!ing and history of cardiovascular diseases (p values of statistical significance areillustrated elow)/

is! factors Bdds atio

(-> Cl)

is! atio (->Cl) E8

uncorrected

E8

used

pvalue

:ypertension 1,11 (0,40-3,07) 1,07 (0,54-2,13) 0,04 0,002 0,83

Diaetes

mellitus

1,38 (0,56-3,36)

1,23 (0,70-2,17) 0,51 0,23 0,47

Smo!ing 0,43 (0,18-1,04)

0,59 (0,34-1,01) 3,53 2,74 0,06

Dyslipemia 0,36 (0,13-0,97)

0,54 (0,31-0,93) 4,18 3,18 0,04

:istory C$

disease

0,70 (0,30-1,64)

0,79 (0,45-1,37) 0,66 0,35 0,41

The logistic regression calculation (ta!ing into account all these ris! factors simultaneously)

identified that hypertension, diaetes mellitus, present smo!ing or history of smo!ing,dyslipemia as well as history of cardiovascular disease are all ris! factors with maor impact onPeripheral Arterial Disease induction"

6 of the maor cardiovascular events (vascular death, myocardial infarction and stro!e%T'A)occurred during the 6 months of follow up in the group of patients with A&' values 3 "- and only1 in those with normal A&' values"

-5 of the patients were on antiplatelet treatment at the inclusion visit/ 57 acetylsalicylicacid, -8 thienopyridine and 6 others, as monotherapy or in cominations"

Date o1 reort*828


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ANGINA PECTORI I!A A"se#t CICD0$00%

10$00%

20$00%

30$00%

40$00%

50$00%

60$00%

70$00%

80$00%

90$00%

100$00%

31$00% 27$00% 27$00%

15$00%

31$00%

58$00%

85$00%

100$00%

&'st* + #a* 'sease

.e/e#te eat'/e .e/e#te ate

0$00%

5$00%

10$00%

15$00%

20$00%

25$00%

30$00%

35$00%

40$00%

10$00%

5$00% 4$00%

26$00%

36$00%

0$00%

8$00%

5$00% 6$00%

D'a#s's + te #a* 'sease


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Alexandra Vilceanu

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