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REWARDS

REWARDS. Ron Waksman , Kimberly Kaneshige, Rebecca Torguson, Probal Roy, Zhenyi Xue, William Suddath, Lowell F. Satler, Kenneth M. Kent, Augusto D. Pichard Washington Hospital Center, Division of Cardiology Washington DC. Disclosures.

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REWARDS

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  1. REWARDS Ron Waksman, Kimberly Kaneshige, Rebecca Torguson, Probal Roy, Zhenyi Xue, William Suddath, Lowell F. Satler, Kenneth M. Kent, Augusto D. Pichard Washington Hospital Center, Division of Cardiology Washington DC

  2. Disclosures • Advisory Board: Medtronic Boston Scientific, Abbott Vascular, Biotronik • Speaker bureau: Medtronic Boston Scientific, Abbott Vascular, Biotronik • Research grants: Medtronic Boston Scientific, Abbott Vascular, Biotronik, Shering Plaugh, GSK, Medicine company, Sanofi BMS

  3. REWARDS Trial Aim The objective of this analysis was to compare the long-term outcomes up to 3 years (Efficacy and Safety) of patients receiving Cypher stents to those receiving Taxus stents with nonrestrictive use for all subset of patients and lesions.

  4. REWARDS Trial Structure • Investigator Sponsor Study • Single Center with 11 cath labs • 30 independent attending investigators • Conducted under local IRB approval • Clinical Follow-up at 1 month, 6 month, 1, 2, and 3 years via telephone or clinic office visit • All events were adjudicated by independent physicians committee • Data Management CRI, Washington Hospital Center

  5. REWARDS Trial Design Successful PCI with DES & Complete 3 year follow up n = 3157 Cypher Stents n = 2192 pts Taxus Stents n = 965 pts Plavix Rx at least 3 M for Cypher and 6 M for Taxus Complete 3 year clinical follow-up all patients

  6. REWARDS Definitions • MACE: Composite of Death, Q wave Myocardial Infarction, Target Vessel Revascularization • Stent Thrombosis: Angiographically documented stent thrombosis • In hospital: prior to discharge • Sub-acute: ≤ 30 days from stent implantation • Late: > 30 days from stent implantation

  7. REWARDS Clinical Presentation

  8. REWARDS Baseline Characteristics

  9. REWARDS In-Hospital Complications

  10. REWARDS Clinical Outcomes 1 Year Clinical Outcomes 2 Year Clinical Outcomes p=0.012 p=0.016

  11. REWARDS Unadjusted 3 Year Clinical Outcomes

  12. Adjusted 3 Year Clinical Outcomes REWARDS P values 0.885 0.214 0.168 0.054 0.080

  13. REWARDS K-M Curve for 3 Year MACE Logrank p=0.52

  14. Independent Predictors of MACE within 3 years REWARDS

  15. REWARDS Cumulative Definite Stent Thrombosis – 3 Years Overall stent thrombosis for both stents at 3 years 1.7%

  16. REWARDS Cumulative Rates of Definite ST %

  17. REWARDS Diabetic Sub-analyses 1) All Diabetics 2) Insulin Dependent Diabetes Mellitus

  18. REWARDS Diabetic Breakdown Successful PCI with DES & Complete 3 year follow up n = 3157 Cypher Stents n = 2192 pts Taxus Stents n = 965 pts All Diabetes Mellitus n = 770 All Diabetes Mellitus n = 348 IDDM n = 243 IDDM n = 115

  19. REWARDS 36 Month MACE P=0.178 P=0.140 P=0.577

  20. REWARDS 36 Month Clinical Outcomes IDDM Overall DM P=0.245 Overall P=0.038 P=0.026 P=0.252 P=0.651 P=0.023

  21. REWARDS 36 Month Cumulative Definite ST P=0.752 P=0.937 P=0.336 %

  22. REWARDS 36 Month Cumulative Definite Late ST P=0.597 P=0.881 P=1.0 %

  23. Adjusted 3 Year MACE REWARDS

  24. Independent Predictors of MACE within 3 years REWARDS

  25. Adjusted 3 Year Death & Q waveMI REWARDS

  26. Independent Predictors of Death& Qwave MI within 3 years REWARDS

  27. REWARDS Summary In an unselected patients population and lesions receiving DES there was no significant difference between patients receiving Cypher or Taxus stents with respect to MACE at 3 years. This similarity remained after adjustment for baseline characteristic differences. Death and Q wave MI were significantly higher in patients receiving Taxus than Cypher stents at 3 years. This significance, however, did not remain after adjustment.

  28. REWARDS Conclusions The present study demonstrated that the use of Cypher and Taxus stents in unrestricted, contemporary practice had a comparable outcome in terms of low rates of revascularization and clinical events through 3 years. Cumulative stent thrombosis, (1.7% at three years for the entire cohort), remains a serious concern for both Cypher and Taxus Stent. These concerns are heightened for the insulin-dependent patients.

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