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

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

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

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

  2. 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

  3. 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

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

  5. 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

  6. Iakovou et al, JACC 2004

  7. 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

  8. Steigen et al, Circulation 2006

  9. Di Mario et al, CCI 2006

  10. Di Mario et al, CCI 2006

  11. 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

  12. 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

  13. Pasceri et al, AHJ 2005

  14. 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

  15. Suttorp et al, Circ 2006

  16. Werner et al, CCI 2005

  17. Werner et al, CCI 2005

  18. 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

  19. Vermeersch et al, JACC 2007

  20. 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

  21. Ardissino et al, JAMA 2004

  22. Stone et al, JAMA 2005

  23. Dawkins et al, Circulation 2005

  24. 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

  25. Spaulding et al, NEJM 2007

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

  27. 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

  28. TRUETaxus™ Multicenter Registry European (Taxus in Real-life Usage Evaluation)

  29. 60% 50% 40% 30% 20% 10% 0% 14 16 18 20 22 8 10 12 The complexity of lesions in TRUE 70% Complex Lesions Lesion Complexity (% C Type) Long Lesions ENDEAVOR I TAXUS VI DELIVER II TAXUS IV FUTURE I C-SIRIUS E-SIRIUS TRUE FUTURE II DELIVER I TAXUS II RAVEL SIRIUS ACTION TAXUS I ASPECT ELUTES Mean lesion length (mm)

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

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

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

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

  34. Kaplan-Meier curve for event-free survival 1,0 ,9 ,8 Survival free from MACE ,7 ,6 ,5 0 4 8 12 2 6 10 Time (months)

  35. Kaplan-Meier curve for stent thrombosis-free survival 1,0 ,9 ,8 Survival free from thrombosis-related events ,7 ,6 ,5 0 4 8 12 2 6 10 Time (months)

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

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

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

  39. Take home messages

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