Background: The effect of oral anticoagulation therapy (OAT) in patients with atrial fibrillation (AF) with a history of intracranial hemorrhage (ICH) is poorly defined. Objective: The purpose of this study was to evaluate the efficacy and safety of OAT in patients with AF with an ICH history. Methods: We retrospectively compared the composite end point, including thromboembolic and major bleeding events, between patients with AF with a history of ICH who were (OAT group, n = 254) and those who were not (no-OAT group, n = 174) taking OAT. Results: During a mean follow-up of 39.5 ± 31.9 months, 5.5 and 3.1 major bleeding events/100 patient-years were observed in the OAT and no-OAT groups, respectively (P =.024). Recurrent ICH was observed only in patient with OAT. Thromboembolic events occurred in 2.4 and 8.3 events/100 patient-years in OAT and no-OAT groups, respectively (P <.001). There was no significant differences in composite end points between OAT and no-OAT groups (11.5 events/100 patient-years vs 7.9 events/100 patient-years; P =.154). Patients with OAT who achieved a time-in-therapeutic range of ≥60% of the international normalized ratio of 2.0–3.0 demonstrated a better cumulative survival free of the composite end point (P <.001) than did patients without OAT. Early (<2 weeks) OAT after an index ICH did not improve composite end points because of the increased incidence of major bleeding events. However, OAT at 2 weeks after an index ICH was associated with decreased clinical events including thromboembolic events and composite end point. Conclusion: In patients with AF who require anticoagulation and have a history of ICH, maintaining optimal OAT with time-in-therapeutic range ≥ 60% and the initiation of OAT at least 2 weeks after an index ICH were associated with improved clinical outcomes
Bibliographical noteFunding Information:
Sources of Funding: This study was supported by a CMB-Yuhan research grant of Yonsei University College of Medicine for (6-2015-0173), research grants from the Basic Science Research Program through the National Research Foundation of Korea funded by the Ministry of Education, Science and Technology (NRF-2012R1A2A2A02045367), and a grant from the Korean Healthcare technology R&D project funded by the Ministry of Health & Welfare (HI16C0058, HI15C1200).
© 2016 Heart Rhythm Society
All Science Journal Classification (ASJC) codes
- Cardiology and Cardiovascular Medicine
- Physiology (medical)