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CLINICAL STUDY REPORT

Study Title PREvalence of peripheral arterial di ea e in acute coronary Syndro!e patiENT Inve ti"ator# $% &&&&&)&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& Data et% O'(ective % 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), ambulator chec!ed"

Secondary%

To identif the #ain Clinical $ariables associated with a higher ris! of PAD among this population To evaluate the therapeutic management of these patients To train Cardiologists to measure An!le % &rachial 'nde( (A&') in order to improve diagnosis of PAD

)ethodolo"y% open)label, non)randomi*ed, national, multicentric, prospective, non)


interventional stud

Nu!'er of patient * u'(ect % Evaluated%


A&' (Cut)off for PAD +,,) -pidemiological data. atherothrombotic ris! factors cardiovascular previous events treatments prescribed at visit / (b therapeutic class)

Dia"no i and criteria for inclu ion%


'nclusion Criteria. patients 0 1+ ears admitted in hospital with diagnosis of Acute Coronar S ndrome or outpatients after an ACS (within last 6 months), ambulator chec!ed2 informed consent signed -(clusion Criteria. patients 3 1+ ears2 patients who did not sign the informed consent form2 patients enrolled in other studies

Criteria for evaluation%


4ill be collected. demographic data of the patient, cardiovascular ris! factors, personal histor of cardiovascular diseases, clinical data, diagnosis of coronar disease, An!le) &rachial 'nde( (A&'), antiplatelet treatment recommended at baseline"

Su!!ary%
Population tudied. /++ patients, with the following gender distribution. 5+6 male and ++6 female and with mean age of 67"88 ears in male group, respective 67"98 ears in female one)" Cardiova cular ri , factor Cardiovascular ris! factors ; pertension Diabetes mellitus Smo!ing % ;istor of smo!ing D slipemia :o <es :o <es :o <es :o <es :o >amil histor of cardiovascular disease <es

Count Column : 6

24 76
=5 19 9/ 6, /, 8/ 98 67

24% 76%
=56 196 9/6 6,6 /,6 8/6 986 676

Per onal hi tory of cardiova cular di ea e /+/ of the patients (59 6) were having histor of coronar disease (angina pectoris, m ocardial infarction etc), 7/ patients (7/6) histor of cerebrovascular disease (stro!e, T'A, carotid stenosis etc) and 97 of them (976) histor of peripheral arterial disease" Clinical data at 'a eline #ean weight was 81"7= !g (89"7= !g in the male group and 85"=, !g in the female one), mean height /5+,1 cm (/5+"=7 cm in the male group and /5+"/+ cm in the female one) and mean waist ,8"=8 cm (,5",1 cm in the male group, respective /++"/1 cm in the female one)" Clinical data : $alid #issing S&P D&P ;eart rate

#ean value

144.37 89"91

5=",/

Dia"no i of the coronary di ea e /59+ of the patients (61"186) were diagnosed with angina pectoris and ,=9 of them (9="=76) with m ocardial infarction" #ean histor of the disease was 7",5 ears" An,le-.rachial Inde/ #A.I$ !ea ure!ent A&' measurement >re?uenc Percent A&' @ +", : A&' 3 +", Total #issing Total 86= /5,+ 76== 78 97"76 66"56 ,,"+6 /"+6

7689 /++"+6

Ri , of !a(or cardiova cular event 'a ed on A.I value A&' classification >re?uenc Percent A&' 0 /"1 : /"1 @ A&' @ +", A&' 3 +", Total #issing Total 6 8=, /5,+ 76== 78 +"76 97"+6 66"56 ,,"+6 /"+6

7689 /++"+6

Antiplatelet therapy reco!!ended at 'a eline Therapeutic class >re?uenc Acet lsalic lic acid A Thienop ridine Thienop ridine Acet lsalic lic acid Acet lsalic lic acid A Thienop ridine A Bthers :o treatment Thienop ridine A Bthers Acet lsalic lic acid A Bthers Bthers Total 67 7/ + 1 7 + + +

Percent 676 7/6 +6 16 76 +6 +6 +"+6

/++ /++"+6

)a(or cardiova cular event occurred durin" the 0 !onth of follo1 up Cardiovascular events Count Column : 6 $ascular death :o <es /++ + ,, / ,8 7 /++6 +6 ,,6 /6 ,86 76

# ocardial infarction :o <es Stro!e % T'A :o <es

Conclu ion %
The prevalence of Peripheral Arterial Disease (PAD) based on A&' measurement in the cohort of 7689 patients admitted to hospital with diagnostic of ACS or outpatients after an ACS (within last 6 months), ambulator chec!ed was of 65"16 (/5,+ patients with A&' values 3 +",)" A&' measurement is also considered as a generali*ed atherosclerotic mar!er that ma allow identif ing patients at high ris! for developing cardio or cerebrovascular events. on top of the patients with A&' values lower than +", there were those ones with A&' values 0 /"1 (+"76) indicating arterial stiffness and, as alread mentioned, ris! of maCor cardiovascular events" The main variables associated with a higher ris! of PAD that have been identified among this population were the following ris! factors. h pertension, diabetes mellitus, present smo!ing or histor of smo!ing and histor of cardiovascular diseases (p values of statistical significance are illustrated below). Dis! factors ; pertension Diabetes mellitus Smo!ing D slipemia ;istor C$ disease Bdds Datio (,=6C') /"97 (/"+5 )/"6/) /"8/ (/"=/ )7"/5) /"9= (/"/9 )/"6) +", (+"5 ) /"/1) /"79 (/"+1 )/"16) Dis! Datio (,=6C') /"+, (/"+7) /"/,) /"/, (/"/9) /"7=) /"/ (/"+1 )/"/6) +",5 (+",/) /"+1) /"+5 (/"+/) /"/9) E7 5"+8 17"+1 //"=/ +"6, =",9 p)value +"++5 +"++++/ +"+++6 +"1+= +"+/

The logistic regression calculation (ta!ing into account all these ris! factors simultaneousl ) identified that h pertension, diabetes mellitus, present smo!ing or histor of smo!ing, d slipemia as well as histor of cardiovascular disease are all ris! factors with maCor impact on Peripheral Arterial Disease induction" 576 of the maCor cardiovascular events (vascular death, m ocardial infarction and stro!e%T'A) occurred during the 6 months of follow up in the group of patients with A&' values 3 +", and onl 786 in those with normal A&' values" ,8",6 of the patients were on antiplatelet treatment at the inclusion visit. 56"76 acet lsalic lic acid, ,9"76 thienop ridine and 1"76 others, as monotherap or in combinations"

.............Dateofreport:

.-

.......................................2014