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CLINICAL STUDY REPORT

Study Title
PREvalence of peripheral arterial dieae in acute coronary Syndro!e patiENT
Inveti"ator#$% &&&&&&'u(or Corina)*alentina #*I+
,-$ &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&
Data et% 6023
O.(ective%
Pri!ary%
 To evaluate the prevalence of Peripheral Arterial Disease (PAD) in patients admitted in
hospital with diagnosis of AC or outpatients after an AC (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$le ( )rachial *nde+ (A)*) in order to improve diagnosis of
PAD
/ethodolo"y% open,la"el! non,randomi-ed! national! multicentric! prospective! non,
interventional stud#
Nu!.er of patient0u.(ect% .00
Evaluated%
A)* (Cut,off for PAD 0!/)
0pidemiological data1
 atherothrom"otic ris$ factors
 cardiovascular previous events
 treatments prescri"ed at visit . ("# therapeutic class)
Dia"noi and criteria for incluion%
 *nclusion Criteria1 patients 2 30 #ears admitted in hospital with diagnosis of Acute
Coronar# #ndrome or outpatients after an AC (within last 6 months)! am"ulator#
chec$ed4 informed consent signed
 0+clusion Criteria1 patients 5 30 #ears4 patients who did not sign the informed consent
form4 patients enrolled in other studies
Criteria for evaluation%
6ill "e collected1 demographic data of the patient! cardiovascular ris$ factors! personal
histor# of cardiovascular diseases! clinical data! diagnosis of coronar# disease! An$le,)rachial
*nde+ (A)*)! antiplatelet treatment recommended at "aseline%
Su!!ary%
Population tudied% .00 patients! with the following gender distri"ution1 678 male and 328
female and with mean age of 6.%39 #ears (9/%76 #ears in male group! respective 63%7. #ears in
female one)%
Cardiovacular ri1 factor
Cardiovascular ris$ factors
Cou
nt
Column :
8
;#pertension
:
o 20 208
<
es 70 708
Dia"etes mellitus
:
o 69 698
<
es 39 398
mo$ing ( ;istor# of smo$ing
:
o 3= 3=8
<
es 93 938
D#slipemia
:
o .9 .98
<
es 79 798
>amil# histor# of cardiovascular
disease
:
o 36 368
<
es 63 638
Peronal hitory of cardiovacular dieae
9/ of the patients (9/8) were having histor# of coronar# disease (angina pectoris! m#ocardial
infarction etc)! .= patients (.=8) histor# of cere"rovascular disease (stro$e! T*A! carotid
stenosis etc) and ./ of them (./8) histor# of peripheral arterial disease%
Clinical data at .aeline
&ean weight was 72%32 $g (73%39 $g in the male group and ==%=7 $g in the female one)! mean
height .6/%96 cm (.=3%29 cm in the male group and .6.%=. cm in the female one) and mean
waist /=%0= cm (/.%=6 cm in the male group! respective 73%06 cm in the female one)%
Clinical
data )P D)P
;eart
rate
:
'alid /7 /7 /7
&issin
g 2 2 2
&ean
value
.39%6
.
79%/
6 =9%69
Dia"noi of the coronary dieae
62 of the patients (628) were diagnosed with angina pectoris and 37 of them (378)
with m#ocardial infarction% &ean histor# of the disease was ???? #ears%
An1le)'rachial Inde2 #A'I$ !eaure!ent
A)*
measurement
>re@uenc
#
Perce
nt
A)* A 0%/ 36 368
: A)* 5 0%/ 63 638
Total .00 .008
&issing 0 08
Total .00
.00%0
8
Ri1 of !a(or cardiovacular event .aed on A'I value
A)*
classification
>re@uen
c#
Percen
t
A)* 2 .%3 33 338
:
.%3 A A)* A
0%/ 2= 2=8
A)* 5 0%/ 30 308
Total .00 .008
&issing 0 08
Total .00 .008
Antiplatelet therapy reco!!ended at .aeline
Therapeutic class
>re@uenc
#
Perce
nt
Acet#lsalic#lic acid B Thienop#ridine =0 =08
Thienop#ridine .7 .78
Acet#lsalic#lic acid 3 38
Acet#lsalic#lic acid B Thienop#ridine B
Cthers 9 98
:o treatment 0 08
Thienop#ridine B Cthers . .8
Acet#lsalic#lic acid B Cthers . .8
Cthers . .8
Total .00 .008
/a(or cardiovacular event occurred durin" the , !onth of follo3 up
Cardiovascular events
Cou
nt
Column :
8
'ascular death
:
o .00 .008
<
es 0 08
&#ocardial
infarction
:
o // //8
<
es . .8
tro$e ( T*A
:
o // //8
<
es . .8
638 of the maDor cardiovascular events (vascular death! m#ocardial infarction and stro$e(T*A)
occurred during the 6 months of follow up in the group of patients with A)* values 5 0%/ and
onl# 368 in those with normal A)* values%
Concluion%
The prevalence of Peripheral Arterial Disease (PAD) "ased on A)* measurement in the cohort
of 2673 patients admitted to hospital with diagnostic of AC or outpatients after an AC (within
last 6 months)! am"ulator# chec$ed was of 3.%978 (30 patients with A)* values 5 0%/)% A)*
measurement is also considered as a generali-ed atherosclerotic mar$er that ma# allow
identif#ing patients at high ris$ for developing cardio or cere"rovascular events1 on top of the
patients with A)* values lower than 0%/ there were those ones with A)* values 2 .%3 (9%968)
indicating arterial stiffness and! as alread# mentioned! ris$ of maDor cardiovascular events%
The main varia"les associated with a higher ris$ of PAD that have "een identified among this
population were the following ris$ factors1 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)1
Eis$ factors Cdds Eatio (/98C*) Eis$ Eatio (/98C*) F
2
p,value
;#pertension 2%0= (0%=6 , 9%60) .%39 (0%73 , 2%.3) .%33 0%23
Dia"etes mellitus 2%09 (0%73 , 9%0=) .%2= (0%/9 , .%67) .%73 0%.=9
mo$ing .%20 (0%93 , 2%=3) .%0= (0%=/ , .%33) 0%097 0%707
D#slipemia .%22 (0%3/ , 3%=6) .%0= (0%6/ , .%6=) 0%003
3
0%/93
638 of the maDor cardiovascular events (vascular death! m#ocardial infarction and stro$e(T*A)
occurred during the 6 months of follow up in the group of patients with A)* values 5 0%/ and
onl# 368 in those with normal A)* values%
/68 of the patients were on antiplatelet treatment at the inclusion visit1 3%.38 acet#lsalic#lic
acid! .7%=98 thienop#ridine and .%038 others! as monotherap# or in com"inations%
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 maDor impact on
Peripheral Arterial Disease induction%
.............Dateofrepor
t:
.......................................-
2014