1 / 21

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.

shayla
Download Presentation

RE-LY : Results with Dabigatran Etexilate

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related