116,889 adult patients with nonvalvular atrial fibrillation (NVAF) initiating DOAC therapy, 51.1% female
Direct oral anticoagulants (DOACs)
Incidence and predictors of Early-ICH (all ICH types within 90 days of initiation) and Late-ICH (beyond 90 days)safety
Early and late intracerebral hemorrhage in DOAC-treated NVAF patients have distinct risk profiles, highlighting the importance of individualized risk stratification.
Abstract Background and aims Although uncommon, intracerebral haemorrhage (ICH) may occur in nonvalvular atrial fibrillation (NVAF) patients treated with direct oral anticoagulants (DOACs). This study aimed to assess the incidence and predictors of ICH in this population. Methods We conducted a retrospective cohort study using electronic health records from a health-maintenance-organization. Adult NVAF patients initiating DOAC therapy between 2013-2024 were reviewed for ICH occurrence during ongoing DOAC treatment. Predictors of Early-ICH (all ICH types within 90 days of initiation) and early subarachnoid haemorrhage (early-SAH) were assessed using logistic regression, while predictors of Late-ICH (beyond 90 days) were evaluated using multivariable Cox regression. Results A total of 116,889 patients (51.1% female) contributed 534,183 patient-years of DOAC exposure. ICH occurred in 4,455 patients (3.81%), with 514 (0.44%) classified as Early-ICH and 3,941 (3.37%) as Late-ICH. Independent predictors of Early-ICH included prior ICH (OR 21.7, 95% CI 17.0–27.6), prior ischemic stroke/TIA (OR 1.66, 95% CI 1.23–2.19), antiepileptic drug use (OR 1.46, 95% CI 1.14–1.85), and male sex (OR 1.45, 95% CI 1.19–1.77) (all p0.001). Predictors for early-SAH included previous ICH (OR 33, 95%CI 20-55) and baseline creatinine (OR 1.3, 95% CI 1-1.6). For Late-ICH, higher baseline INR (HR 1.23, 95% CI 1.02–1.48, p=0.03) and older age at initiation (HR 1.01 per year, 95% CI 1.01–1.04, p0.001) increased risk, whereas prior warfarin use was protective (HR 0.58, 95% CI 0.48–0.72, p0.001). Conclusions Early and Late ICH in DOAC-treated NVAF patients have distinct risk profiles, highlighting the importance of individualized risk stratification. Conflict of interest Asaf Honig,Ruth Smadar, Gal Ifergane, Jeremy Molad: Nothing to disclose
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Ruth Smadar‐Shneyour
Gal Ifergane
Jeremy Molad
European Stroke Journal
Ben-Gurion University of the Negev
Tel Aviv Sourasky Medical Center
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Smadar‐Shneyour et al. (Fri,) studied this question.
www.synapsesocial.com/papers/69fd7e42bfa21ec5bbf066d1 — DOI: https://doi.org/10.1093/esj/aakag023.728