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 [email protected]1
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The Long Term Multi-Center Extension of Dabigatran Treatment in Patients with Atrial Fibrillation (RELY-ABLE) study To reviewers and moderators: These.
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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 [email protected]
2
RE-LY: Results with Dabigatran Etexilate
• 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
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
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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
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Patient Flow: RE-LY and RELY-ABLE
DE 110 DE 150
Randomized to dabigatran in RE-LY 6015 6076
Completed RE-LY alive, on Dabigatran 4492 (74.7%) 4519 (74.4%)
Followed at site participating in RELY-ABLE 3395 (75.6%) 3397 (75.2%)
Patient enrolled in RELY-ABLE 2914 (85.8%) 2937 (86.5%)
Completed RELY-ABLE still receiving study medication
2511 (86.2%) 2508 (85.4%)
Continued in RELY-ABLE beyond the 28 month visit
1082 (43.5%) 1104 (44.0%)
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RE-LY Baseline Characteristics: Patients in enrolling or not enrolling in RELY-ABLE