Patients in the RE-LY randomized to treatment with dabigatran, to participate in long-term follow-up study RELY-ABLE. It enrolled the 5851 patients who were followed for an average of 2.3 years.
The incidence of stroke or systemic embolism and major bleeding incidence remained low and was consistent with the study RE-LY. At a dose of 150 mg twice daily of dabigatran was slightly higher incidence of major bleeding as compared with a dose of 110 mg twice daily.
The incidence of thromboembolic events and mortality were similar for both doses of dabigatran.