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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