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Tony Gershlick University Hospitals of Leicester UK

PROTECT TRIAL. Tony Gershlick University Hospitals of Leicester UK. Speaker Bureau, Advisory Board, Recipient Research Grants Medtronic Vascular. Bare metal stent (n=878). Bare metal stent (n=1,757). CYPHER stent (n=870). TAXUS stent (n=1,749). 0. 0. 1. 1. 2. 2. 3. 3. 4. 4.

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Tony Gershlick University Hospitals of Leicester UK

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  1. PROTECT TRIAL Tony Gershlick University Hospitals of Leicester UK

  2. Speaker Bureau, Advisory Board, Recipient Research Grants Medtronic Vascular

  3. Bare metal stent (n=878) Bare metal stent (n=1,757) CYPHER stent (n=870) TAXUS stent (n=1,749) 0 0 1 1 2 2 3 3 4 4 Independent CRF patient-level meta-analysisFreedom From Death or Myocardial Infarction RAVEL, SIRIUS, E-SIRIUS, C-SIRIUS (n=1,748) TAXUS I, II, IV, V, VI (n=3,506) 89.7% (88) 88.2% (182) P=0.39 P=0.77 88.4% (100) 87.6% (186) Time after Initial Procedure (years) Time after Initial Procedure (years) Conclusion : No clinical difference in outcome out to 4 years

  4. Freedom From (Protocol) Stent Thrombosis RAVEL, SIRIUS, E-SIRIUS, and C-SIRIUS (n=1,748) TAXUS I, II, IV, V, VI (n=3,506) 99.4% (5) 99.1% (14) P=0.20 P=0.29 98.8% (10) 98.7% (20) Bare metal stent (n=878) Bare metal stent (n=1,757) CYPHER stent (n=870) TAXUS stent (n=1,749) 4 4 0 1 2 3 0 1 2 3 Time after Initial Procedure (years) Time after Initial Procedure (years) Independent CRF patient-level meta-analysis

  5. 99.1% (14) P=0.29 98.7% (20) 99.4% (5) P=0.20 98.8% (10) After 1 year After 1 year 9vs. 2, P=0.033 5vs. 0, P=0.025 Variation in Definitions Bare metal stent (n=878) Bare metal stent (n=1,757) CYPHER stent (n=870) TAXUS stent (n=1,749) 0 0 1 1 2 2 3 3 4 4 Freedom From (Protocol) Stent Thrombosis RAVEL, SIRIUS, E-SIRIUS, and C-SIRIUS (n=1,748) TAXUS I, II, IV, V, VI (n=3,506) Time after Initial Procedure (years) Time after Initial Procedure (years) No clinical sequelae

  6. Definite or Probable : Cypher versus Velocity Definite or Probable : Endeavor versus Driver New (ARC) Definitions Sirolimus-Eluting - - - - - Bx Velocity - - - - - ENDEAVOR - - - - - Driver - - - - - 1.5%versus1.7% p= 0.70 0.5%versus1.4% p= 0.06

  7. Need for • Long term adequately powered trial • Handle on whether any one stent presents less of a risk

  8. All patients who you currently now treat

  9. CYPHER & ENDEAVOR on shelf • @ up to 100+50 patients / site • UK ~ 2000 - 3500 /8800 patients • Trial time-lines • Finalisation protocol Current • Ethics • Ist patient projected • Interim analysis • trial duration 3 years • Subgroup studies UK : APT compliance PROTECT –AMI & the UK

  10. In Conclusion : PROTECT-AMI - a large, important study with significant UK input – READY TO GO !!!

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