Risk of Bleeding With 2 Doses of Dabigatran Compared With Warfarin in Older and Younger Patients With Atrial Fibrillation An Analysis of the Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY) Trial

Background-Dabigatran 150 and 110 mg twice a day and warfarin are effective for stroke prevention in atrial fibrillation. The purpose of this study was to compare their risks of bleeding in the Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY) trial. Methods and Results-The RE-LY trial randomized 18 113 patients to receive dabigatran 110 or 150 mg twice a day or warfarin dose adjusted to an international normalized ratio of 2.0 to 3.0 for a median follow-up of 2.0 years. Compared with warfarin, dabigatran 110 mg twice a day was associated with a lower risk of major bleeding (2.87% versus 3.57%; P=0.002), whereas dabigatran 150 mg twice a day was associated with a similar risk of major bleeding (3.31% versus 3.57%; P=0.32). There was a significant treatment-by-age interaction, such that dabigatran 110 mg twice a day compared with warfarin was associated with a lower risk of major bleeding in patients aged = 75 years (4.43% versus 4.37%; P=0.89; P for interaction = 75 years (5.10% versus 4.37%; P=0.07; P for interaction = 75 years, intracranial bleeding risk is lower but extracranial bleeding risk is similar or higher with both doses of dabigatran compared with warfarin.

Wallentin, Lars,1943-Uppsala universitet,Institutionen för medicinska vetenskaper,Uppsala kliniska forskningscentrum (UCR)(Swepub:uu)larswall (author)
Connolly, Stuart J. (author)
Ezekowitz, Mike (author)
Healey, Jeff S. (author)
Oldgren, Jonas,1964-Uppsala universitet,Institutionen för medicinska vetenskaper,Uppsala kliniska forskningscentrum (UCR)(Swepub:uu)jonaoldg (author)
Yang, Sean (author)
Alings, Marco (author)
Kaatz, Scott (author)
Hohnloser, Stefan H. (author)
Diener, Hans-Christoph (author)
Franzosi, Maria Grazia (author)
Huber, Kurt (author)
Reilly, Paul (author)
Varrone, Jeanne (author)
Yusuf, Salim (author)
Uppsala universitetInstitutionen för medicinska vetenskaper (creator_code:org_t)

By the author/editor: Eikelboom, John ...; Wallentin, Lars, ...; Connolly, Stuart ...; Ezekowitz, Mike; Healey, Jeff S.; Oldgren, Jonas, ...; show more...; Yang, Sean; Alings, Marco; Kaatz, Scott; Hohnloser, Stefa ...; Diener, Hans-Chr ...; Franzosi, Maria ...; Huber, Kurt; Reilly, Paul; Varrone, Jeanne; Yusuf, Salim; show less...

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