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===Primary Outcomes=== | ===Primary Outcomes=== | ||
*Stroke or Systemic Embolism | |||
**stroke: sudden onset of focal neuro deficit, location consistent with major vessel | |||
**systemic embolism: acute vascular occlusion of extremity or organ, by imaging, surgical confirmation, or autopsy | |||
*Primary safety outcome: Major Bleeding (all other bleeding considered minor) | |||
**Defined as: Hg drop of 20 g/L, transfusion of 2 units PRBC, or symptomatic bleed in critical area or organ | |||
**Life-threatening bleed (subcategory) | |||
***fatal bleed, symptomatic ICH, decrease in Hgb of at least 50 g/L, transfusion of 4 units PRBC, inotropic agents or surgery required | |||
===Secondary Outcomes=== | ===Secondary Outcomes=== | ||
*Hemorrhagic stroke | |||
*Death | |||
*MI | |||
*PE | |||
*TIA | |||
*Hospitalization | |||
===Subgroup analysis=== | ===Subgroup analysis=== | ||
==Criticisms== | ==Criticisms== | ||
Revision as of 22:06, 31 October 2014
incomplete Journal Club Article
Connolly SJ, et al. "Dabigatran versus warfarin in patients with atrial fibrillation". The New England Journal of Medicine. 2009. 361(12):1139-51.
PubMed Full text PDF
PubMed Full text PDF
Clinical Question
Is dabigatran (brand name Pradaxa) safe for use in patients with atrial fibrillation when compared to warfarin in terms of stroke and bleeding risks.
Conclusion
In comparison to warfarin in patients with atrial fibrillation, dabigatran given at a dose of 110 mg demonstrated similar stroke and lower bleeding rates. At 150 mg, dabigatran use was associated with lower rates of stroke and systemic embolism but similar rates of major hemorrhage.
Major Points
Design
- Randomized, prospective, blinded, multinational study
- Patients recruited from 951 clinical sites in 44 countries
- 3 treatment groups: Warfarin, Dabigatrin 110 mg BID, Dabigatrin 150 mg BID
- Dabigatrin groups were blinded, Warfarin was not
- Followed for 2 years
Inclusion Criteria
- A-Fib on screening EKG or within the past 6 months AND one of the following:
- Previous stroke or TIA
- LVEF<40%
- NYHA class II or higher w/ in past 6 months
- age at least 75 yrs or 64-74 plus DM, HTN, or CAD
Exclusion Criteria
- Severe heart-valve disorder
- Stroke within 14 days or severe stroke within 6 months
- Condition increasing risk of hemorrhage
- CRCL <30mL/min
- Active liver disease
- Pregnancy
- Recent surgery
Interventions
Three groups, of which Dabigatran participants were blinded and Warfarin participants were not
- Warfarin, adjusted dose, goal INR 2.0-3.0
- Dabigatran 110 mg BID
- Dabigatran 150 mg BID
Outcome
Primary Outcomes
- Stroke or Systemic Embolism
- stroke: sudden onset of focal neuro deficit, location consistent with major vessel
- systemic embolism: acute vascular occlusion of extremity or organ, by imaging, surgical confirmation, or autopsy
- Primary safety outcome: Major Bleeding (all other bleeding considered minor)
- Defined as: Hg drop of 20 g/L, transfusion of 2 units PRBC, or symptomatic bleed in critical area or organ
- Life-threatening bleed (subcategory)
- fatal bleed, symptomatic ICH, decrease in Hgb of at least 50 g/L, transfusion of 4 units PRBC, inotropic agents or surgery required
Secondary Outcomes
- Hemorrhagic stroke
- Death
- MI
- PE
- TIA
- Hospitalization