Drug-Eluting Stents in Challenging Lesions: Randomized Trials and Registries

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

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









DiabeticsDiabetics


Iakovou et al, JACC 2004

OutlineOutline









DiabeticsDiabetics


Steigen et al, Circulation 2006

Di Mario et al, CCI 2006

OutlineOutline









DiabeticsDiabetics


Pasceri et al, AHJ 2005

OutlineOutline









DiabeticsDiabetics


Suttorp et al, Circ 2006

Werner et al, CCI 2005

OutlineOutline









DiabeticsDiabetics


Vermeersch et al, JACC 2007

OutlineOutline









DiabeticsDiabetics


Ardissino et al, JAMA 2004

Stone et al,

JAMA 2005

Dawkins et al, Circulation 2005

OutlineOutline









DiabeticsDiabetics


Spaulding et al, NEJM 2007

TAXUS diabetics meta-analysis TAXUS diabetics meta-analysis (N=715)(N=715)

Baim, FDA Panel 2006

BMSPES

OutlineOutline









DiabeticsDiabetics


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


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


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


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


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

For further slides on these topics For further slides on these topics please feel free to visit the please feel free to visit the

metcardio.org website:metcardio.org website:

http://www.http://www.metcardiometcardio..orgorg//slidesslides..htmlhtml

Drug-Eluting Stents in Challenging Lesions: Randomized Trials and Registries

Documents

Transcript of Drug-Eluting Stents in Challenging Lesions: Randomized Trials and Registries