CLINICAL STUDY REPORT

Study Title PREvalence of peripheral arterial di ea e in acute coronary Syndro!e patiENT Inve ti"ator# $% &&&&&POPESCU Ion (XX, 222)&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& Data et% 101 O'(ective % Pri!ary%
To evaluate the prevalence of Peripheral Arterial Disease (PAD) in patients admitted in hospital with diagnosis of ACS or outpatients after an ACS (within last 6 months) am!ulator" chec#ed$

Secondary%

To identif" the %ain Clinical &aria!les 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+la!el interventional stud"

non+randomi,ed

national

multicentric

prospective

non+

Nu!'er of patient * u'(ect % -6./ Evaluated%

A() (Cut+off for PAD 0 0) 1pidemiological data2 atherothrom!otic ris# factors cardiovascular previous events treatments prescri!ed at visit 1 (!" therapeutic class)

Dia"no i and criteria for inclu ion%

)nclusion Criteria2 patients 3 40 "ears admitted in hospital with diagnosis of Acute Coronar" S"ndrome or outpatients after an ACS (within last 6 months) am!ulator" chec#ed5 informed consent signed 1*clusion Criteria2 patients 6 40 "ears5 patients who did not sign the informed consent form5 patients enrolled in other studies

Criteria for evaluation%

7ill !e collected2 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 !aseline$

Su!!ary%
Population tudied2 -6./ patients with the following gender distri!ution2 68$/< male and /-$8< female and with mean age of 6/$8; "ears (6;$0; "ears in male group respective 6;$/8 "ears in female one)$ Cardiova cular ri + factor Cardiovascular ris# factors 9"pertension Dia!etes mellitus Smo#ing ' 9istor" of smo#ing D"slipemia >amil" histor" of cardiovascular disease :o =es :o =es :o =es :o =es :o =es

Count Column : < ;40 -1/4 1604 0.0 08/ 1810 4/8 --46 11-1;61 -0$;< 80$;< 6/$1< /6$0< /6$/< 6/$8< 16$/< ./$8< 41$.< ;.$-<

Per onal hi tory of cardiova cular di ea e 10-; of the patients ( -1 <) were having histor" of coronar" disease (angina pectoris m"ocardial infarction etc) -- patients (10$1<) histor" of cere!rovascular disease (stro#e T)A carotid stenosis etc) and 40 of them (//$1<) histor" of peripheral arterial disease$ Clinical data at 'a eline %ean weight was ./$/- #g (.;$0/ #g in the male group and 88$06 #g in the female one) mean height 180$/1 cm (18/$.6 cm in the male group and 16/ cm in the female one) and mean waist 0.$-8 cm (00$/. cm in the male group r espective 0;$04 cm in the female one)$ Clinical data S(P D(P 9eart rate : &alid %issing -681 -680 11/ -6;/1 8;$.1

%ean value

144$8- .4$-/

Dia"no i of the coronary di ea e 18/0 of the patients (64$4.<) were diagnosed with angina pectoris and 0;/ of them (/;$;-<) with m"ocardial infarction$ %ean histor" of the disease was -$08 "ears$ An+le,-rachial Inde. #A-I$ !ea ure!ent A() measurement >re?uenc" Percent A() @ 0$0 : A() 6 0$0 Total %issing Total .6; 1800 -6;; -. /-$-< 66$8< 00$0< 1$0<

-6./ 100$0<

Ri + of !a(or cardiova cular event 'a ed on A-I value A() classification >re?uenc" Percent A() 3 1$4 : 1$4 @ A() @ 0$0 A() 6 0$0 Total %issing Total 6 .;0 1800 -6;; -. 0$-< /-$0< 66$8< 00$0< 1$0<

-6./ 100$0<

Antiplatelet therapy reco!!ended at 'a eline Therapeutic class 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 >re?uenc" Percent 1./1 ;./ 1-8 66 /0 -1 -0 ; 6.$-< -1$8< 4$8< -$;< 1$1< 0$.< 0$8< 0$-<

-6./ 100$0<

)a(or cardiova cular event occurred durin" the / !onth of follo0 up Cardiovascular events Count Column : < &ascular death %"ocardial infarction Stro#e ' T)A :o =es :o =es :o =es -68; . -6;0 -4 -6/6 48 00$8< 0$/< 00$1< 0$0< 0.$-< 1$.<

8-< 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 6 0$0 and onl" -.< in those with normal A() values$

Conclu ion %
The prevalence of Peripheral Arterial Disease (PAD) !ased on A() measurement in the cohort of -6./ patients admitted to hospital with diagnostic of ACS or outpatients after an ACS (within last 6 months) am!ulator" chec#ed was of 68$4< (1800 patients with A() values 6 0$0)$ 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 cere!rovascular events2 on top of the patients with A() values lower than 0$0 there were those ones with A() values 3 1$4 (0$-<) indicating arterial stiffness and as alread" mentioned ris# of maCor cardiovascular events$ The main varia!les associated with a higher ris# of PAD that have !een identified among this population were the following ris# factors2 h"pertension dia!etes mellitus present smo#ing or histor" of smo#ing and histor" of cardiovascular diseases (p values of statistical significance are illustrated !elow)2 Dis# factors 9"pertension Dia!etes mellitus Smo#ing D"slipemia 9istor" C& disease Bdds Datio (0;<C)) 1$/- (1$08+1$61) 1$.1 (1$;1+-$18) 1$/; (1$1/+1$6) 0$0 (0$8+1$14) 1$-/ (1$04+1$46) Dis# Datio (0;<C)) 1$00 (1$0-+1$10) 1$10 (1$1/+1$-;) 1$1 (1$04+1$16) 0$08 (0$01+1$04) 1$08 (1$01+1$1/) E8$0. 4-$04 11$;1 0$60 ;$0/ p+value 0$008 0$00001 0$0006 0$40; 0$01

The logistic regression calculation (ta#ing into account all these ris# factors simultaneousl") identified that h"pertension dia!etes 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$ 8-< 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 6 0$0 and onl" -.< in those with normal A() values$ 0.$0< of the patients were on antiplatelet treatment at the inclusion visit2 86$-< acet"lsalic"lic acid 0/$-< thienop"ridine and 4$-< others as monotherap" or in com!inations$

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

.-

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