Oral Anticoagulants for Nonvalvular Atrial Fibrillation in Patients With High Risk of Gastrointestinal Bleeding



Lip, Gregory YH ORCID: 0000-0002-7566-1626, Keshishian, Allison V, Zhang, Yan, Kang, Amiee, Dhamane, Amol D, Luo, Xuemei, Klem, Christian, Ferri, Mauricio, Jiang, Jenny, Yuce, Huseyin
et al (show 1 more authors) (2021) Oral Anticoagulants for Nonvalvular Atrial Fibrillation in Patients With High Risk of Gastrointestinal Bleeding. JAMA NETWORK OPEN, 4 (8). e2120064-.

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Abstract

<h4>Importance</h4>Many patients with nonvalvular atrial fibrillation (NVAF) are at a high risk of gastrointestinal (GI) bleeding due to conditions including older age; stage III to V chronic kidney disease (CKD); HAS-BLED (hypertension, kidney or liver disease, stroke history, prior bleeding, unstable international normalized ratio, age >65, drug or alcohol use) score of 3 or greater; corticosteroid, antiplatelet or nonsteroidal anti-inflammatory drug (NSAID) use; or GI conditions.<h4>Objective</h4>To compare the risk of stroke and/or systemic embolism (SE) and major bleeding (MB) among patients with NVAF and high risk of GI bleeding who received non-vitamin K antagonist oral anticoagulants (NOACs) vs those who received warfarin.<h4>Design, setting, and participants</h4>This retrospective cohort study included patients with NVAF who were 75 years and older; had stage III to V CKD; had an HAS-BLED score of 3 or greater; used corticosteroids, antiplatelets, or NSAIDs; or had GI conditions. Data were collected from the Centers for Medicare & Medicaid Services and 4 commercial insurance databases between January 1, 2012, and September 30, 2015. Data analysis was conducted from January 2012 to September 2015.<h4>Exposures</h4>New prescription for apixaban, dabigatran, rivaroxaban, or warfarin between January 1, 2013, and September 30, 2015 (identification period).<h4>Main outcomes and measures</h4>Six propensity score-matched cohorts were created to compare between study drugs. For the primary objective, Cox models were used to estimate stroke and/or SE and MB hazard ratios (HRs).<h4>Results</h4>A total of 381 054 patients (187 489 [49.2%] women) with NVAF and at least 1 high-risk GI bleeding factor were identified (HAS-BLED score ≥3: 284 527 [74.7%]; aged ≥75 years: 252 835 [66.4%]; corticosteroid, antiplatelet, or NSAID therapy: 107 675 [28.3%]; prior GI bleeding conditions: 74 818 [19.6%]; and stage III-V CKD: 56 892 [14.9%]). All NOACs were associated with a lower risk of stroke and/or SE 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). Compared with warfarin, apixaban and dabigatran were associated with a lower risk of MB (apixaban: HR, 0.59; 95% CI, 0.56-0.63; dabigatran: HR, 0.78; 95% CI, 0.70-0.86), while rivaroxaban was associated with a higher risk (HR, 1.11; 95% CI, 1.05-1.16).<h4>Conclusions and relevance</h4>In this study of patients with NVAF and high risk of GI bleed, NOACs were associated with lower rates of stroke and/or SE, but NOACs had varying risks of MB compared with warfarin. These results may help inform treatment options in this patient population.

Item Type: Article
Uncontrolled Keywords: Humans, Atrial Fibrillation, Gastrointestinal Hemorrhage, Pyrazoles, Pyridones, Warfarin, Anticoagulants, Treatment Outcome, Administration, Oral, Risk Factors, Retrospective Studies, Cohort Studies, Aged, Aged, 80 and over, United States, Female, Male, Rivaroxaban, Dabigatran
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Institute of Life Courses and Medical Sciences
Depositing User: Symplectic Admin
Date Deposited: 17 Oct 2023 14:26
Last Modified: 17 Oct 2023 14:26
DOI: 10.1001/jamanetworkopen.2021.20064
Open Access URL: https://jamanetwork.com/journals/jamanetworkopen/f...
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URI: https://livrepository.liverpool.ac.uk/id/eprint/3173824