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Safety of high-dose dabigatran in elderly and younger patients with a low bleeding risk: A prospective observational study

Cardiology Jun 16, 2021

Erez A, Golovchiner G, Klempfner R, et al. - Researchers undertook this prospective observational study to assess whether DE150 (dabigatran 150 mg twice a day) is safe relative to warfarin in a real-world population with atrial fibrillation (AF) and low bleeding risk (HAS-BLED score ≤2). Participants were 754 consecutive patients with AF and HAS-BLED score ≤2. Elderly patients (age ≥75 tears) were compared with younger patients (age <75 years), in terms of outcomes. The combined incidence of all-cause mortality, stroke, systemic emboli, and major bleeding event during a mean follow-up of 1 year, was set as the primary endpoint. The cumulative event rate of the combined endpoint was 8.9% in the DE150 and 15.9% in the warfarin, at 1-year of follow-up, in the elderly. Post-adjustment for age and gender, a nonsignificant difference in the risk for the combined endpoint was observed between patients who were treated with DE150 and those managed with warfarin, both among the elderly and among the younger population. Overall, findings demonstrated the safety of Dabigatran 150 mg in elderly AF patients with low bleeding risk, when administered twice a day.

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