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RE-LY : Results with Dabigatran Etexilate

The Long Term Multi- Center Extension of Dabigatran Treatment in Patients with Atrial Fibrillation (RELY-ABLE) study. To reviewers and moderators: These are preliminary slides. The figures are going to be upgraded this week and I can send these to you if you email me at connostu@phri.ca.

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RE-LY : Results with Dabigatran Etexilate

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  1. The Long Term Multi-Center Extension of Dabigatran Treatment in Patients with Atrial Fibrillation (RELY-ABLE) study To reviewers and moderators: These are preliminary slides. The figures are going to be upgraded this week and I can send these to you if you email me at connostu@phri.ca

  2. RE-LY: Results with DabigatranEtexilate • Dabigatran (DE) 150 mg BID and 110 mg BID versus warfarin • An 18,113 Patient Global Clinical Trial Mean follow up 2 years • DE 150 reduced stroke/SEE by 35% versus warfarin • DE 110 non-inferior to warfarin, with 20% reduction in major bleeding • Greater than 50% reduction in intracranial bleeding with both doses compared to warfarin • Regulatory approval in 79 countries as of November 2012 Reference

  3. RELY-ABLE Design • Descriptive study to assess long-term efficacy and safety of two doses of DE • 28 months of additional treatment with DE following RE-LY • Patients eligible if completed RE-LY • Alive and on study medication • DE blinded dose continued in RELY-ABLE • No event adjudication • Follow up stopped if study medication discontinued

  4. Data Analysis Primary analysis RELY-ABLE patients during RELY-ABLE period of follow up Secondary Analyses RELY-ABLE patients followed from beginning of RE-LY to end of RELY-ABLE All dabigatran patients, from beginning of RE-LY to the end of RELY-ABLE

  5. Patient Flow: RE-LY and RELY-ABLE

  6. RE-LY Baseline Characteristics: Patients in enrolling or not enrolling in RELY-ABLE

  7. Event Rates during RE-LY: Enrolled versus not enrolled patients

  8. Ischemic Events: RELY-ABLE patients in RELY-ABLE follow up period

  9. Stroke or SEE RELY-ABLE Patients in RELY-ABLE Period

  10. Ischemic Events: RE-LY + RELY-ABLE Periods

  11. Stroke or Systemic Embolism: RE-LY + RELY-ABLE periods All Dabigatran RELY-ABLE Only

  12. Bleeding: RELY-ABLE patients in RELY-ABLE follow up period RELY-ABLE Period Only

  13. Major Bleeding RELY-ABLE Patients in RELY-ABLE Period

  14. Bleeding: RE-LY + RELY-ABLE Periods

  15. Major Bleeding: RELY-ABLE Only All Dabigatran

  16. Net Benefit: RELY-ABLE

  17. Total Mortality

  18. Net Benefit: RE-LY + RELY-ABLE Periods

  19. Total Mortality: RE-LY + RELY-ABLE Periods All Dabigatran patients

  20. Sub-groups: RE-LY + RELY-ABLE Stoke or Systemic embolism Major Bleeding Total Mortality 150mg better 110mg better 150mg better 110mg better 150mg better 110mg better # PTS P(INTER) P(INTER) P(INTER) OVERALL 12091 AGE <65 2028 AGE 65-74 5248 AGE 75+ 4815 0.60 0.95 0.31 MALE 7705 FEMALE 4385 0.14 0.76 0.39 STROKE/ SEE/TIA 2666 NONE 9424 0.86 0.02 0.04 CHADS 0-1 3921 CHADS 2 4224 CHADS 3+ 3945 0.36 0.44 0.03 CCLEAR <50 49 CCLEAR 50-79 2379 CCLEAR 80 5655 0.64 0.42 0.63 0.0 0.5 1.00 1.5 2.0 0.0 0.5 1.00 1.5 2.0 0.0 0.5 1.00 1.5 2.0 Hazard Ratio Hazard Ratio Hazard Ratio

  21. Conclusions • During 2.3 years of treatment on dabigatran, after RE-LY, rates of stroke and major bleeding remain low on dabigatran • Including all dabigatran follow up, there is a dose response effect • With dabigatran 150 mg compared to 110 mg • 22% reduction in ischemic stroke • 20% increase in major bleeding • Very similar mortality

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