Early Bleeding Risk After DOAC Initiation With Concomitant Amiodarone in Older Adults With Atrial Fibrillation.

Area of Science:

• Cardiology
• Pharmacology
• Geriatrics

Background:

• Amiodarone is often prescribed with direct oral anticoagulants (DOACs) for atrial fibrillation (AF).
• The impact of amiodarone on early bleeding risk following DOAC initiation in elderly patients is not well understood.
• This study investigates short-term safety outcomes of concurrent amiodarone use during DOAC initiation.

Purpose of the Study:

• To evaluate the association between concomitant amiodarone use and early bleeding events in older adults initiating DOACs.
• To assess the risk of gastrointestinal bleeding, intracranial hemorrhage, and ischemic stroke.

Main Methods:

• Retrospective propensity score-matched cohort study using the TriNetX US Research Network (2015-2025).
• Included adults aged 75+ with nonvalvular AF initiating a DOAC.
• Defined exposure as amiodarone use within 30 days before or on the DOAC start date. Matched 1:1 on demographics, comorbidities, and medications.
• Primary outcomes: GI bleeding and intracranial hemorrhage (ICH); Secondary outcome: ischemic stroke over 90 days.

Main Results:

• 136,806 patients (68,403 per cohort) were included after matching.
• Concomitant amiodarone use was linked to increased early bleeding risk: GI bleeding (HR 1.30) and ICH (HR 1.28).
• No significant difference in ischemic stroke risk was observed (HR 0.91).

Conclusions:

• Concomitant amiodarone use with DOACs in older adults (75+) is associated with a modest but significant increase in 90-day GI bleeding and ICH.
• No increased risk of ischemic stroke was detected.
• Highlights the need for careful medication review, dose selection, and bleeding risk counseling when prescribing amiodarone with DOACs to elderly patients.