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Health Equity

Session: Poster Session B

(194) Sex-Specific Comparative Effectiveness and Safety of Direct Oral Anticoagulants vs Warfarin in Patients with Atrial Fibrillation - A Systematic Review and Meta-Analysis

Saturday, August 26, 2023
8:00 AM – 6:00 PM ADT
Location: Convention Hall
Publication Number: 855

    Presenting Author(s)

  • Jan Chobanov, MSc

    PhD Student
    Research Department of Practice and Policy, School of Pharmacy, University College London, United Kingdom

Background: Females with atrial fibrillation (AF) are underrepresented in randomised control trials (RCTs) of direct oral anticoagulants (DOACs) despite having higher stroke risk. Individual studies are often too small to assess sex-specific outcomes to guide DOAC treatment choices.

Objectives: This systematic review and meta-analysis of RCTs and observational studies aimed to determine sex-specific outcomes of DOACs and warfarin in patients with AF.

Methods: PubMed, EMBASE, Web of Science, and Cochrane Library were searched from January 2008 to November 2022. Effectiveness and safety outcomes were stroke/systemic embolism (SE), major bleeding, intracranial haemorrhage (ICH) and gastrointestinal bleeding (GIB). DerSimonion–Laird random-effect model was used to generate pooled risk ratio (pRR) with 95% confidence interval (CI).

Results: Five RCTs and 33 observational studies comprising 1,085,931 females and 1,387,123 males were included. Meta-analysis identified sex-specific differences for GIB; females have higher GIB risk with rivaroxaban (female: pRR=1.34, 95%CI=1.18–1.51; male: pRR=0.97, 95%CI=0.85–1.1; p-interaction <0.001) and potentially dabigatran (female: pRR=1.25, 95%CI=0.92–1.70; male: pRR=0.83, 95%CI=0.72–0.97; p-interaction=0.02) compared to warfarin which were unobserved in males. Otherwise for both sexes, DOACs generally had lower stroke/SE, major bleeding, and ICH risk compared to warfarin and rivaroxaban compared to dabigatran had similar stroke/SE but raised GIB and ICH risk.

Conclusions: DOACs are generally effective and safe in both sexes. However, GIB risk may be raised in females using rivaroxaban and dabigatran compared to warfarin. Consideration of patient sex may be needed when selecting optimal DOAC. For both sexes, rivaroxaban may have a higher bleeding risk compared to dabigatran. Further research is warranted to examine the sex-specific outcomes between all DOACs.