Dabigatran For Stroke Prevention In Patients With Atrial Fibrillation and Previous Stroke Or Transient Ischemic Attack: Does Dose Matter?

Abstract

Evaluation of: Diener HC, Connolly SJ, Ezekowitz MD et al.: Dabigatran compared with warfarin in patients with atrial fibrillation and previous transient ischaemic attack or stroke: a subgroup analysis of the RE-LY trial. Lancet Neurol. 9(12), 1157–1163 (2010). This study aimed to assess the efficacy and safety of daibgatran in two doses (110 and 150 mg) compared with warfarin in a prespecified subgroup analysis of patients with previous stroke or transient ischemic attack in the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial. There were nonsignificant risk reductions for the primary outcome (stroke and systemic embolism) for both doses of dabigatran compared with warfarin in this subgroup of patients. However, the 110-mg dose of dabigatran provided significantly greater reductions of mortality and higher net clinical benefit compared with warfarin. This was not seen in the 150-mg dose. The bleeding complication rates of this subgroup were consistent with the main RE-LY trial. In the warfarin group, patients with previous history of stroke or transient ischemic attack developed more intracranial bleeding than patients without this history, but this was not the case in dabigatran treatment groups.