Post on 21-Jan-2016
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Drug-Eluting Drug-Eluting Stents in Stents in
Challenging Challenging Lesions: Lesions:
Randomized Trials Randomized Trials and Registriesand Registries
Drug-Eluting Drug-Eluting Stents in Stents in
Challenging Challenging Lesions: Lesions:
Randomized Trials Randomized Trials and Registriesand Registries
OutlineOutline
Definition of challenging lesionDefinition of challenging lesion
Aorto-ostial lesionsAorto-ostial lesions
Bifurcation lesionsBifurcation lesions
Unprotected left mainUnprotected left main
Thrombotic lesionsThrombotic lesions
Total occlusionsTotal occlusions
Safenous vein graftsSafenous vein grafts
Long lesions and small vesselsLong lesions and small vessels
DiabeticsDiabetics
TRUE StudyTRUE Study
OutlineOutline
Definition of challenging lesionDefinition of challenging lesion
Aorto-ostial lesionsAorto-ostial lesions
Bifurcation lesionsBifurcation lesions
Unprotected left mainUnprotected left main
Thrombotic lesionsThrombotic lesions
Total occlusionsTotal occlusions
Safenous vein graftsSafenous vein grafts
Long lesions and small vesselsLong lesions and small vessels
DiabeticsDiabetics
TRUE StudyTRUE Study
Definition of challenging Definition of challenging lesionlesion
Any lesion with features associated with a higher risk of procedural failure or peri-procedural adverse events
OutlineOutline
Definition of challenging lesionDefinition of challenging lesion
Aorto-ostial lesionsAorto-ostial lesions
Bifurcation lesionsBifurcation lesions
Unprotected left mainUnprotected left main
Thrombotic lesionsThrombotic lesions
Total occlusionsTotal occlusions
Safenous vein graftsSafenous vein grafts
Long lesions and small vesselsLong lesions and small vessels
DiabeticsDiabetics
TRUE StudyTRUE Study
Iakovou et al, JACC 2004
OutlineOutline
Definition of challenging lesionDefinition of challenging lesion
Aorto-ostial lesionsAorto-ostial lesions
Bifurcation lesionsBifurcation lesions
Unprotected left mainUnprotected left main
Thrombotic lesionsThrombotic lesions
Total occlusionsTotal occlusions
Safenous vein graftsSafenous vein grafts
Long lesions and small vesselsLong lesions and small vessels
DiabeticsDiabetics
TRUE StudyTRUE Study
Steigen et al, Circulation 2006
Di Mario et al, CCI 2006
Di Mario et al, CCI 2006
OutlineOutline
Definition of challenging lesionDefinition of challenging lesion
Aorto-ostial lesionsAorto-ostial lesions
Bifurcation lesionsBifurcation lesions
Unprotected left mainUnprotected left main
Thrombotic lesionsThrombotic lesions
Total occlusionsTotal occlusions
Safenous vein graftsSafenous vein grafts
Long lesions and small vesselsLong lesions and small vessels
DiabeticsDiabetics
TRUE StudyTRUE Study
OutlineOutline
Definition of challenging lesionDefinition of challenging lesion
Aorto-ostial lesionsAorto-ostial lesions
Bifurcation lesionsBifurcation lesions
Unprotected left mainUnprotected left main
Thrombotic lesionsThrombotic lesions
Total occlusionsTotal occlusions
Safenous vein graftsSafenous vein grafts
Long lesions and small vesselsLong lesions and small vessels
DiabeticsDiabetics
TRUE StudyTRUE Study
Pasceri et al, AHJ 2005
OutlineOutline
Definition of challenging lesionDefinition of challenging lesion
Aorto-ostial lesionsAorto-ostial lesions
Bifurcation lesionsBifurcation lesions
Unprotected left mainUnprotected left main
Thrombotic lesionsThrombotic lesions
Total occlusionsTotal occlusions
Safenous vein graftsSafenous vein grafts
Long lesions and small vesselsLong lesions and small vessels
DiabeticsDiabetics
TRUE StudyTRUE Study
Suttorp et al, Circ 2006
Werner et al, CCI 2005
Werner et al, CCI 2005
OutlineOutline
Definition of challenging lesionDefinition of challenging lesion
Aorto-ostial lesionsAorto-ostial lesions
Bifurcation lesionsBifurcation lesions
Unprotected left mainUnprotected left main
Thrombotic lesionsThrombotic lesions
Total occlusionsTotal occlusions
Safenous vein graftsSafenous vein grafts
Long lesions and small vesselsLong lesions and small vessels
DiabeticsDiabetics
TRUE StudyTRUE Study
Vermeersch et al, JACC 2007
OutlineOutline
Definition of challenging lesionDefinition of challenging lesion
Aorto-ostial lesionsAorto-ostial lesions
Bifurcation lesionsBifurcation lesions
Unprotected left mainUnprotected left main
Thrombotic lesionsThrombotic lesions
Total occlusionsTotal occlusions
Safenous vein graftsSafenous vein grafts
Long lesions and small vesselsLong lesions and small vessels
DiabeticsDiabetics
TRUE StudyTRUE Study
Ardissino et al, JAMA 2004
Stone et al,
JAMA 2005
Dawkins et al, Circulation 2005
OutlineOutline
Definition of challenging lesionDefinition of challenging lesion
Aorto-ostial lesionsAorto-ostial lesions
Bifurcation lesionsBifurcation lesions
Unprotected left mainUnprotected left main
Thrombotic lesionsThrombotic lesions
Total occlusionsTotal occlusions
Safenous vein graftsSafenous vein grafts
Long lesions and small vesselsLong lesions and small vessels
DiabeticsDiabetics
TRUE StudyTRUE Study
Spaulding et al, NEJM 2007
TAXUS diabetics meta-analysis TAXUS diabetics meta-analysis (N=715)(N=715)
Baim, FDA Panel 2006
BMSPES
OutlineOutline
Definition of challenging lesionDefinition of challenging lesion
Aorto-ostial lesionsAorto-ostial lesions
Bifurcation lesionsBifurcation lesions
Unprotected left mainUnprotected left main
Thrombotic lesionsThrombotic lesions
Total occlusionsTotal occlusions
Safenous vein graftsSafenous vein grafts
Long lesions and small vesselsLong lesions and small vessels
DiabeticsDiabetics
TRUE StudyTRUE Study
TRUETRUE TaxusTaxus™™ Multicenter Multicenter
Registry EuropeanRegistry European
((TTaxus in axus in RReal-life eal-life UUsage sage EEvaluation)valuation)
DELIV
ER II
TAXUS
II
ASPEC
T
Mean lesion length (mm)
FUTU
RE II
E-SI
RIUS
SIRIU
S
TAXUS
IV
DELIV
ER I
C-SIR
IUS
FUTU
RE I
8 10 12 14 16 18 20 22
Lesi
on
Com
ple
xit
y (
% C
Typ
e)
RAVEL
ELUTE
S
0%
60%
50%
40%
30%
20%
10%
ACTION
TAXUS
I
ENDEA
VOR I
Complex Lesions
LongLesions
TAXUS
VI
The complexity of lesions in The complexity of lesions in TRUETRUE
70%
TRUE
Patient distribution (n=1065)Patient distribution (n=1065)by intentional treatment
Diabetesn=322 (30%)
Unprotected Left Main
n=115 (11%)
Bifurcations Trifurcations n=229 (22%)
Long lesions n=289 (27%)
CTOn=191 (18%)
Small vesselsn=430 (40%)
18,6
1,13,8
1,1
14
10
0
5
10
15
20
25
MACE Death MI CABG TVR TLR
Inci
denc
e %
Overall 7-month follow-up Overall 7-month follow-up (N=1065)(N=1065)
19,2
1,44
1,1
14,2
10,1
0
5
10
15
20
25
MACE Death MI CABG TVR TLR
Inci
denc
e %
Overall 12-month follow-up Overall 12-month follow-up (N=1065)(N=1065)
0,30,2
0,3
0
0,8
0
0,5
1
1,5
Acute Subacute 1-6 months >6 months Cumulative
Inci
denc
e %
Overall ARC-probable stent thrombosis Overall ARC-probable stent thrombosis (n=1065) (n=1065)
Kaplan-Meier curve for event-free Kaplan-Meier curve for event-free survivalsurvival
,9
,8
,7
,6
,5
Time (months)
121086420
Su
rviv
al fr
ee
fro
m M
AC
E
1,0
Kaplan-Meier curve for stent Kaplan-Meier curve for stent thrombosis-free survivalthrombosis-free survival
Time (months)
121086420
Su
rviv
al fr
ee
fro
m
thro
mbo
sis-
rela
ted
eve
nts
,9
,8
,7
,6
,5
1,0
26,1
5,7 4,9 3,7
18,1
13,3
0
5
10
15
20
25
30
35
MACE Death MI CABG TVR TLR
Inci
den
ce %
Unprotected left main 7-month follow-up Unprotected left main 7-month follow-up (N=115) (N=115)
17,1
2,81,4 1,4
16,9
12,7
0
4
8
12
16
20
MACE Death MI CABG TVR TLR
N=25 N=2
Inci
den
ce %
N=24 N=18N=4 N=2
Chronic total occlusions 7-month follow-up (N=191)Chronic total occlusions 7-month follow-up (N=191)
15,2
3,25,2
1,4
13,1
7,5
0
4
8
12
16
20
MACE Death MI CABG TVR TLR
Inci
den
ce %
Diabetes mellitus 7-month follow-up Diabetes mellitus 7-month follow-up (N=322)(N=322)
Take home messagesTake home messages
Take home messagesTake home messages
DES usage in challenging lesions is DES usage in challenging lesions is associated with favorable early and associated with favorable early and mid-term results in most casesmid-term results in most cases
Notable exceptions may be safenous Notable exceptions may be safenous vein grafts and diabetic patients (the vein grafts and diabetic patients (the latter applies to sirolimus-eluting stents latter applies to sirolimus-eluting stents only)only)
Lesion preparation and accurate choice Lesion preparation and accurate choice of the most appropriate platform-drug of the most appropriate platform-drug combination for each individual lesion combination for each individual lesion are also pivotal to maximize success are also pivotal to maximize success and long-term efficacyand long-term efficacy
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metcardio.org website:metcardio.org website:
http://www.http://www.metcardiometcardio..orgorg//slidesslides..htmlhtml