Stroke and Bleeding Risks With Non-Vitamin K Oral Anticoagulants in Nonvalvular Atrial Fibrillation

Area of Science:

• Cardiology
• Pharmacology
• Health Services Research

Background:

• Previous studies indicated rivaroxaban had a less favorable benefit-harm profile in older Medicare patients using non-vitamin K oral anticoagulants (NOACs).
• The comparative safety and efficacy of NOACs in younger populations with nonvalvular atrial fibrillation (NVAF) remain less understood.

Purpose of the Study:

• To compare the risks of major extracranial bleeding (MEB), gastrointestinal bleeding (GIB), intracranial hemorrhage (ICH), and thromboembolic stroke.
• To evaluate outcomes among individuals younger than 65 years using different standard-dose NOACs for NVAF.

Main Methods:

• A cohort study utilized health care claims data from the FDA Sentinel System (October 2010 - February 2022).
• Included were 173,000+ patients aged 21-64 with NVAF using rivaroxaban, apixaban, or dabigatran.
• Inverse probability of treatment-weighted pairwise comparisons estimated hazard ratios for key adverse events.

Main Results:

• Apixaban demonstrated a more favorable benefit-harm profile compared to rivaroxaban, with lower risks of MEB and GIB.
• Rivaroxaban was associated with significantly higher risks of MEB and GIB versus apixaban.
• Dabigatran showed a higher risk of thromboembolic stroke compared to both rivaroxaban and apixaban.

Conclusions:

• In patients under 65 with NVAF, apixaban appears to offer the most favorable benefit-harm profile among commonly used NOACs.
• Rivaroxaban use was linked to increased bleeding risks without superior stroke prevention compared to apixaban.
• Higher stroke risks with dabigatran suggest potential age-related differences in NOAC effectiveness requiring further investigation.