Gender Related Differences in Gastrointestinal Bleeding With Oral Anticoagulation in Atrial Fibrillation

Area of Science:

• Cardiology
• Pharmacology
• Gastroenterology

Background:

• Direct oral anticoagulants (DOACs) are associated with increased gastrointestinal (GI) bleeding risk.
• Female patients were underrepresented in pivotal DOAC trials.
• Real-world data on gender-specific GI bleeding risk with DOACs versus vitamin K antagonists (VKAs) is limited.

Purpose of the Study:

• To compare real-world GI bleeding incidence between males and females using DOACs and VKAs in atrial fibrillation patients.
• To investigate potential gender-based differences in GI bleeding risk associated with different oral anticoagulant classes.

Main Methods:

• Population-based retrospective analysis of linked administrative claims data.
• Inclusion of atrial fibrillation patients aged 65 years and above.
• Time-to-event analysis comparing GI bleeding between genders, adjusting for bleeding risk factors (HAS-BLED, prior GI disease).

Main Results:

• The cohort included 15,338 DOAC users (55% female) and 44,542 VKA users (50% female).
• Females using DOACs had a higher incidence of GI bleeding (0.90%) versus males (0.59%), with a hazard ratio of 1.48 (95% CI 1.02-2.16) after adjustment.
• No significant gender difference in GI bleeding was observed among VKA users.

Conclusions:

• Female patients treated with DOACs exhibit a higher risk of GI bleeding compared to male patients.
• This observed gender disparity in GI bleeding risk is specific to DOACs and not seen with VKAs.
• Findings highlight the need for gender-specific considerations in DOAC therapy for atrial fibrillation.