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

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Presentation transcript:

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

Outline Definition of challenging lesion Aorto-ostial lesions Bifurcation lesions Unprotected left main Thrombotic lesions Total occlusions Safenous vein grafts Long lesions and small vessels Diabetics TRUE Study

Outline Definition of challenging lesion Aorto-ostial lesions Bifurcation lesions Unprotected left main Thrombotic lesions Total occlusions Safenous vein grafts Long lesions and small vessels Diabetics TRUE Study

Definition of challenging lesion Any lesion with features associated with a higher risk of procedural failure or peri-procedural adverse events

Outline Definition of challenging lesion Aorto-ostial lesions Bifurcation lesions Unprotected left main Thrombotic lesions Total occlusions Safenous vein grafts Long lesions and small vessels Diabetics TRUE Study

Iakovou et al, JACC 2004

Outline Definition of challenging lesion Aorto-ostial lesions Bifurcation lesions Unprotected left main Thrombotic lesions Total occlusions Safenous vein grafts Long lesions and small vessels Diabetics TRUE Study

Steigen et al, Circulation 2006

Di Mario et al, CCI 2006

Outline Definition of challenging lesion Aorto-ostial lesions Bifurcation lesions Unprotected left main Thrombotic lesions Total occlusions Safenous vein grafts Long lesions and small vessels Diabetics TRUE Study

Outline Definition of challenging lesion Aorto-ostial lesions Bifurcation lesions Unprotected left main Thrombotic lesions Total occlusions Safenous vein grafts Long lesions and small vessels Diabetics TRUE Study

Pasceri et al, AHJ 2005

Outline Definition of challenging lesion Aorto-ostial lesions Bifurcation lesions Unprotected left main Thrombotic lesions Total occlusions Safenous vein grafts Long lesions and small vessels Diabetics TRUE Study

Suttorp et al, Circ 2006

Werner et al, CCI 2005

Outline Definition of challenging lesion Aorto-ostial lesions Bifurcation lesions Unprotected left main Thrombotic lesions Total occlusions Safenous vein grafts Long lesions and small vessels Diabetics TRUE Study

Vermeersch et al, JACC 2007

Outline Definition of challenging lesion Aorto-ostial lesions Bifurcation lesions Unprotected left main Thrombotic lesions Total occlusions Safenous vein grafts Long lesions and small vessels Diabetics TRUE Study

Ardissino et al, JAMA 2004

Stone et al, JAMA 2005

Dawkins et al, Circulation 2005

Outline Definition of challenging lesion Aorto-ostial lesions Bifurcation lesions Unprotected left main Thrombotic lesions Total occlusions Safenous vein grafts Long lesions and small vessels Diabetics TRUE Study

Spaulding et al, NEJM 2007

TAXUS diabetics meta-analysis (N=715) Baim, FDA Panel 2006 BMS PES

Outline Definition of challenging lesion Aorto-ostial lesions Bifurcation lesions Unprotected left main Thrombotic lesions Total occlusions Safenous vein grafts Long lesions and small vessels Diabetics TRUE Study

TRUE Taxus™ Multicenter Registry European ( Taxus in Real-life Usage Evaluation) ( Taxus in Real-life Usage Evaluation)

DELIVER II TAXUS II ASPECT Mean lesion length (mm) FUTURE II E-SIRIUS SIRIUS TAXUS IV DELIVER I C-SIRIUS FUTURE I Lesion Complexity (% C Type) RAVEL ELUTES 0% 60% 50% 40% 30% 20% 10% ACTION TAXUS I ENDEAVOR I Complex Lesions Long Lesions TAXUS VI The complexity of lesions in TRUE 70% TRUE

Patient distribution (n=1065) by intentional treatment Diabetes n=322 (30%) Unprotected Left Main n=115 (11%) Bifurcations Trifurcations n=229 (22%) Long lesions n=289 (27%) CTO n=191 (18%) Small vessels n=430 (40%)

Incidence % Overall 7-month follow-up (N=1065)

Incidence % Overall 12-month follow-up (N=1065)

Incidence % Overall ARC-probable stent thrombosis (n=1065)

Kaplan-Meier curve for event-free survival,9,8,7,6,5 Time (months) Survival free from MACE 1,0

Kaplan-Meier curve for stent thrombosis- free survival Time (months) Survival free from thrombosis-related events,9,8,7,6,5 1,0

Incidence % Unprotected left main 7-month follow-up (N=115)

N=25N=2 Incidence % N=24N=18 N=4N=2 Chronic total occlusions 7-month follow-up (N=191)

Incidence % Diabetes mellitus 7-month follow-up (N=322)

Take home messages

DES usage in challenging lesions is associated with favorable early and mid- term results in most cases Notable exceptions may be safenous vein grafts and diabetic patients (the latter applies to sirolimus-eluting stents only) Lesion preparation and accurate choice of the most appropriate platform-drug combination for each individual lesion are also pivotal to maximize success and long- term efficacy

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