Long-Term Clinical Outcomes of Underdosed Direct Oral Anticoagulants in Patients with Atrial Fibrillation and Atrial Flutter |
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| Authors: | Hasan Ashraf Pradyumna Agasthi Anusha Shanbhag Ramila A. Mehta Pattara Rattanawong Mohamed Allam Sai Harika Pujari Farouk Mookadam William K. Freeman Komandoor Srivathsan Dan Sorajja Win-Kuang Shen Peter A. Noseworthy Eric H. Yang Hicham Z. El Masry Xiaoxi Yao Siva K. Mulpuru Nirat Beohar Reza Arsanjani |
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| Affiliation: | 1. Department of Cardiovascular Diseases, Mayo Clinic, Phoenix Ariz;2. Department of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minn;3. Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minn;4. Department of Health Care Policy and Research, Mayo Clinic, Rochester, Minn;5. Division of Cardiology, Mount Sinai Medical Center, Miami, Fla;1. Department of Medicine, University of Maryland Medical Center, Baltimore;2. Department of Medicine, Division of Endocrinology, Diabetes & Metabolism, Johns Hopkins School of Medicine, Baltimore, Md;3. Department of Medicine, Providence VA Medical Center and Alpert Medical School of Brown University, Providence, RI;4. Department of Epidemiology and Prevention, Wake Forest University School of Medicine, Winston-Salem, NC;1. Department of Internal and Emergency Medicine, Buergerspital Solothurn, Solothurn, Switzerland;2. Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology, Wilheminenspital, Vienna, Austria;3. Department of Emergency Medicine, Inselspital, University Hospital Bern, Bern, Switzerland |
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| Abstract: | BackgroundAlthough direct oral anticoagulants (DOACs) have been shown to be effective at reducing the risk of stroke in patients with atrial fibrillation/flutter (AF), they are sometimes underdosed off-label to mitigate their associated higher bleeding risk. We sought to evaluate frequency and clinical outcomes of inappropriate underdosing of DOACS in patients with AF.MethodsWe conducted a study of subjects with AF who had a clinical indication for stroke prophylaxis (with a congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke or transient ischemic attack, vascular disease, age 65 to 47 years, sex category [CHA2DS2-VASc] of 2 or greater) and were prescribed 1 of the 4 clinically approved DOACs (apixaban, rivaroxaban, dabigatran, or edoxaban). We compared all-cause mortality, composite of stroke and systemic embolism, composite of myocardial infarction (MI), acute coronary syndromes (ACS), and coronary revascularization, and major bleeding between patients appropriately dosed and inappropriately underdosed.ResultsA total of 8125 patients met inclusion criteria, with a mean follow up of 2.2 ± 2 years. Of those, 1724 patients (21.2%) were inappropriately dosed. After adjusting for baseline variables, there was no difference in all-cause mortality, risk of stroke or systemic embolism, International Society on Thrombosis and Haemostasis (ISTH) major bleeding, or composite of myocardial infarction, acute coronary syndromes, or coronary revascularization between patients appropriately dosed and inappropriately underdosed. In subgroup analysis, only apixaban demonstrated an increased incidence all-cause mortality (hazard ratio [HR] 1.24, 95% confidence interval [CI] 1.03-1.49) with inappropriate underdosing. There was no difference in the remaining clinical outcomes noted on subgroup analysis.ConclusionUnderdosing of DOACs did not minimize risk of bleeding, systemic embolization or all-cause mortality in patients with AF. Inappropriate underdosing with apixaban in particular was associated with increased all-cause mortality. |
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| Keywords: | Atrial fibrillation Atrial flutter Bleeding Direct oral anticoagulants Stroke Underdose |
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