EBQ:RE-LY

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

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.

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