Clinical outcomes of dabigatran use in patients with non-valvular atrial fibrillation and weight >120 kg.

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Citation: Thrombosis Research. 208:176-180, 2021 Dec.PMID: 34808409Institution: Washington Cancer InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Atrial Fibrillation | *Dabigatran | Atrial Fibrillation/co [Complications] | Atrial Fibrillation/dt [Drug Therapy] | Dabigatran/ae [Adverse Effects] | Gastrointestinal Hemorrhage | Humans | Longitudinal Studies | Retrospective StudiesYear: 2021ISSN:
  • 0049-3848
Name of journal: Thrombosis researchAbstract: BACKGROUND: Patients with obesity were underrepresented in studies evaluating the safety and effectiveness of direct oral anticoagulants (DOAC) in patients with non-valvular atrial fibrillation (NVAF). This study compared clinical outcomes in patients with NVAF and weighing >120 kg and <=120 kg who were receiving dabigatran.CONCLUSIONS: In patients with NVAF and >120 kg, dabigatran use was associated with a small increased risk of gastrointestinal bleeding but no differences in stroke, mortality or clinically-relevant bleeding. These findings suggest that dabigatran use is reasonable in patients with NVAF and weight >120 kg. Copyright © 2021 Elsevier Ltd. All rights reserved.MATERIALS AND METHODS: This retrospective, matched, longitudinal cohort study included patients from three integrated healthcare delivery systems. Patients >=18 years of age with NVAF were included if between September 1, 2016 and June 30, 2019 they received dabigatran. Patients >120 kg and <=120 kg were matched up to 1:6 on age, sex, and CHA2DS2-VASc score. Data were extracted from administrative databases. The primary outcome was a composite of ischemic stroke, clinically-relevant bleeding, systemic embolism, and all-cause mortality. Multivariable regression analyses were performed.RESULTS: 777 and 3522 patients >120 kg and <=120 kg, respectively, were matched. The >120 kg group tended to be younger with a higher burden of chronic disease. There was no difference between groups in the composite outcome (adjusted hazard ratio [AHR] 1.10, 95% confidence interval 0.89-1.37) or individual components of the composite. A subanalysis of clinically-relevant bleeding identified that patients >120 kg were at a greater risk of gastrointestinal bleeding (AHR 1.44, 95% CI 1.01-2.05).All authors: Bitton E, Clark NP, Coates J, Delate T, Fink KM, Hendje A, Knowles C, Ly S, Olson KLFiscal year: FY2022Digital Object Identifier: Date added to catalog: 2022-12-13
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Journal Article MedStar Authors Catalog Article 34808409 Available 34808409

BACKGROUND: Patients with obesity were underrepresented in studies evaluating the safety and effectiveness of direct oral anticoagulants (DOAC) in patients with non-valvular atrial fibrillation (NVAF). This study compared clinical outcomes in patients with NVAF and weighing >120 kg and <=120 kg who were receiving dabigatran.

CONCLUSIONS: In patients with NVAF and >120 kg, dabigatran use was associated with a small increased risk of gastrointestinal bleeding but no differences in stroke, mortality or clinically-relevant bleeding. These findings suggest that dabigatran use is reasonable in patients with NVAF and weight >120 kg. Copyright © 2021 Elsevier Ltd. All rights reserved.

MATERIALS AND METHODS: This retrospective, matched, longitudinal cohort study included patients from three integrated healthcare delivery systems. Patients >=18 years of age with NVAF were included if between September 1, 2016 and June 30, 2019 they received dabigatran. Patients >120 kg and <=120 kg were matched up to 1:6 on age, sex, and CHA2DS2-VASc score. Data were extracted from administrative databases. The primary outcome was a composite of ischemic stroke, clinically-relevant bleeding, systemic embolism, and all-cause mortality. Multivariable regression analyses were performed.

RESULTS: 777 and 3522 patients >120 kg and <=120 kg, respectively, were matched. The >120 kg group tended to be younger with a higher burden of chronic disease. There was no difference between groups in the composite outcome (adjusted hazard ratio [AHR] 1.10, 95% confidence interval 0.89-1.37) or individual components of the composite. A subanalysis of clinically-relevant bleeding identified that patients >120 kg were at a greater risk of gastrointestinal bleeding (AHR 1.44, 95% CI 1.01-2.05).

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