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RE-LY : Results with Dabigatran Etexilate PowerPoint PPT Presentation


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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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RE-LY : Results with Dabigatran Etexilate

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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 [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


Patient flow re ly and rely able

Patient Flow: RE-LY and RELY-ABLE


Re ly baseline characteristics patients in enrolling or not enrolling in rely able

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


Event rates during re ly enrolled versus not enrolled patients

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


Ischemic events rely able patients in rely able follow up period

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


Stroke or see

Stroke or SEE

RELY-ABLE Patients in RELY-ABLE Period


Ischemic events re ly rely able periods

Ischemic Events: RE-LY + RELY-ABLE Periods


Stroke or systemic embolism re ly rely able periods

Stroke or Systemic Embolism: RE-LY + RELY-ABLE periods

All Dabigatran

RELY-ABLE Only


Bleeding rely able patients in rely able follow up period

Bleeding: RELY-ABLE patients in RELY-ABLE follow up period

RELY-ABLE Period Only


Major bleeding

Major Bleeding

RELY-ABLE Patients in RELY-ABLE Period


Bleeding re ly rely able periods

Bleeding: RE-LY + RELY-ABLE Periods


Major bleeding1

Major Bleeding:

RELY-ABLE Only

All Dabigatran


Net benefit rely able

Net Benefit: RELY-ABLE


Total mortality

Total Mortality


Net benefit re ly rely able periods

Net Benefit: RE-LY + RELY-ABLE Periods


Total mortality re ly rely able periods

Total Mortality: RE-LY + RELY-ABLE Periods

All Dabigatran patients


Sub groups re ly rely able

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


Conclusions

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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