Compared with warfarin, non-vitamin K antagonist oral anticoagulants (NOACs) are associated with lower rates of stroke and/or systemic embolism (SE) but varying rates of major bleeding in patients with nonvalvular atrial fibrillation (NVAF) at high risk of gastrointestinal (GI) bleed, according to the findings of a retrospective cohort study recently published in JAMA Network Open.

To compare the risk of stroke and/or systemic embolism as well as major bleeding in this patient population, the obtained data from the Centers for Medicare & Medicaid Services as well as 4 commercial insurance databases between January 1, 2012 and September 30, 2015.

Patients included in the study were required to have NVAF, be at least 75 years old, have stage III to V chronic kidney disease (CKD) or GI conditions, have a HAS-BLED score of at least 3, and have received corticosteroids, antiplatelets, or nonsteroidal anti-inflammatory drugs (NSAIDs). Stroke and/or systemic embolism and major bleeding hazard ratios (HRs) were estimated using Cox models.

A total of 381,054 NVAF patients with at least 1 high-risk GI bleeding factor were identified. Of these patients, 49.2% (n=187,489) were female, 74.7% (n=284,527) had a HAS-BLED score of at least 3, 66.4% (n=252,835) were at least 75 years old, 28.3% (n=107,675) received corticosteroid, antiplatelet, or NSAID therapy, 19.6% (n=74,818) had prior GI bleeding conditions, and 14.9% (n=56,892) had stage III to V CKD.


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“All NOACs were associated with a lower risk of stroke and/or [systemic embolism] vs warfarin (apixaban: HR, 0.60; 95% CI, 0.52-0.68; dabigatran: HR, 0.75; 95% CI, 0.64-0.88; rivaroxaban: HR, 0.79; 95%CI, 0.73-0.86),” the authors reported. Findings of the analysis also showed a decreased risk of major bleeding in patients who received apixaban (HR, 0.59; 95% CI, 0.56-0.63) and dabigatran (HR, 0.78; 95% CI, 0.70-0.86) and an increased risk of major bleeding in patients who received rivaroxaban (HR, 1.11; 95% CI, 1.05-1.16) compared with those who received warfarin.

“This is one of the first real-world studies to compare NOACs in patients with NVAF and high risk of GI bleed; the results may help inform decision-making regarding OACs in this high-risk patient population,” the authors concluded.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

Reference

Lip GYH, Keshishian AV, Zhang Y. Oral Anticoagulants for nonvalvular atrial fibrillation in patients with high risk of gastrointestinal bleeding. JAMA Network Open. Published online August 16, 2021. doi:10.1001/jamanetworkopen.2021.20064