CLINICAL STUDY REPORT Study Title Prevalence of peripheral arterial di ea e in acute coronary Syndro!

e patient

Inve ti"ator# E!!a Li"ia Nea"oe$ Seria %$ &rupa '( Data et# E ant %)
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, noninterventional 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 7,6 female and with mean age of 61 ears ( 61,718 ears in male group, respective

61,666 ears in female one)" Cardiovascular ris! factors 9o : pertension ;es 9o Diabetes mellitus ;es 9o Smo!ing% :istor of smo!ing ;es 9o D slipemia ;es 9o =amil histor of cardiovascular disease ;es Count Column 9 6 8+ 8+6 55-6 <6 <66 11 116 7< 7<6 6< 6<6 8+ 8+6 55-6 18 186 <> <>6

Per onal hi tory of cardiova cular di ea e 5, of the patients (5, 6) were having histor of coronar disease (angina pectoris, m ocardial infarction etc), +6 patients ( +66) histor of cerebrovascular disease (stro!e, T'A, carotid stenosis etc) and 78 of them ( 6) histor of peripheral arterial disease" Clinical data at *a eline #ean weight was >7,>5!g (>1,+8 !g in the male group and >7,86 !g in the female one), mean :eight +,,16 cm ( +58,55 cm in the male group and +6<,,6 cm in the female one) and mean waist -5,<> cm ( -5,<8 cm in the male group, respective ->,58 cm in the female one)" Clinical data $alid 9 #issing #ean value S&P +,, , +17,+5, D&P -+ >1,51< :eart rate -+ 5<,>6>

Dia"no i of the coronary di ea e 88 of the patients ( 7+6) were diagnosed with angina pectoris and 71 of them ( 1>6) with m ocardial infarction" #ean histor of the disease was 6,+8 ears" An.le/0rachial Inde1 2A0I3 !ea ure!ent A&' measurement =re?uenc Percent 9 A&' @ ,"7+ 7+6 A&' 3 ,"66 666 Total -5 -56 #issing 7 76 Total +,, +,6

Ri . of !a+or cardiova cular event *a ed on A0I value A&' classification =re?uenc Percent 9 A&'0+"1 , ,6 +"1@A&'@,"66 666 A&'3,"7+ 7+6 Total -5 -56 #issing 7 76 Total +,, +,,6 Antiplatelet therapy reco!!ended at *a eline Therapeutic class =re?uenc Percent Acet lsalic lic acid A 66-6 Thienop ridine Thienop ridine 88 886 Acet lsalic lic acid 1, 1,6 Acet lsalic lic acid A 7 76 Thienop ridine A Bthers 9o treatment + +6 Thienop ridine A Bthers , ,6 Acet lsalic lic acid A Bthers + +6 Bthers , ,6 Total +,, +,,6 ,a+or cardiova cular event occurred durin" the 4 !onth of follo5 up Cardiovascular events Count Columnb 96 9o ---6 $ascular death ;es + +6 9o +,, +,,6 # ocardial infarction ;es , ,6 9o -5 -56 Stro!e%T'A ;es 7 76
+,,6 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 ,6 in those with normal A&' values"

Conclu ion #
The prevalence of Peripheral Arterial Disease (PAD) based on A&' measurement in the cohort of +,, patients admitted to hospital with diagnostic of ACS or outpatients after an ACS (within last 6 months), ambulator chec!ed was of 16 ( 1patients 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 ( ,6) 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 blow)/

illustrated below)/D i s ! factors : pertension Diabetes mellitus Smo!ing D slipemia :istor C$ disease

Bdds Datio (-<6C') +,<8-1 (,,<,,6)1,657,) ,,5<5- (,,7+,-)+,>8,) ,,6168 (,,8656)+,<6,7) 8,+6,,(,,6<6+)5,++,6) ,,57>< (,,7+7,)+,518<)

Dis! Datio (-<6C') +,7<,6 (,,<-17)7,,6->) ,,>85+ (,,1<7<)+,<,>7) ,,5157 (,,1+>-)+,777,) +,5<78 (,,6-77)1,1776) ,,>+1< (,,1<65)+,1<8-)

E8

p)value ,,875>,,85+6,,+5+,> ,,+,15< ,,81>>6

,,<6++ ,"7-,,,-1>1 +,6<5, ,,1>,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" +,,6 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 , 6 in those with normal A&' values" --6 of the patients were on antiplatelet treatment at the inclusion visit/ 1,6 acet lsalic lic acid, 886 thienop ridine and 756 others, as monotherap or in combinations" Date of report: 17/01/2014

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