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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]

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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]


Re ly results with dabigatran etexilate
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


Rely able design
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


Data analysis
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





Ischemic events rely able patients in rely able follow up period
Ischemic patientsEvents: RELY-ABLE patients in RELY-ABLE follow up period


Stroke or see
Stroke or SEE patients

RELY-ABLE Patients in RELY-ABLE Period



Stroke or systemic embolism re ly rely able periods
Stroke or Systemic patientsEmbolism: RE-LY + RELY-ABLE periods

All Dabigatran

RELY-ABLE Only


Bleeding rely able patients in rely able follow up period
Bleeding: patientsRELY-ABLE patients in RELY-ABLE follow up period

RELY-ABLE Period Only


Major bleeding
Major Bleeding patients

RELY-ABLE Patients in RELY-ABLE Period



Major bleeding1
Major patientsBleeding:

RELY-ABLE Only

All Dabigatran



Total mortality
Total Mortality patients



Total mortality re ly rely able periods
Total Mortality: RE-LY + RELY-ABLE Periods patients

All Dabigatran patients


Sub groups re ly rely able
Sub-groups: RE-LY + RELY-ABLE patients

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


Conclusions
Conclusions patients

  • 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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