Abstract and Introduction

Abstract

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.