Clinical outcomes of dabigatran use in patients with non-valvular atrial fibrillation and weight >120 kg. Issue 208 (December 2021)

• Record Type: Journal Article
• Authors: Coates, Jamie; Bitton, Emily; Hendje, Ashley; Delate, Thomas; Olson, Kari L.; Knowles, Carla; Ly, Sara; Fink, Kristen M.; Clark, Nathan P.
• Is Part Of: Thrombosis research. Issue 208(2021)
• Page Start: 176
• Page End: 180
• Publication Date: 2021-12
• Subjects: Dabigatran -- Factor Xa inhibitors -- Atrial fibrillation -- Obesity -- Safety; Thrombosis -- Periodicals; 616.135
• DOI: 10.1016/j.thromres.2021.11.007
• Languages: English
• ISSNs: 0049-3848

Abstract

Abstract: 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. 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 CHA2 DS2 -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). 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. Highlights: DOAC use in patients >120 kg creates the potential for poor clinical outcomes Real-world data on DOAC use in patients >120 kg are limited Overall, dabigatran's outcomes were equivalent between patients ≤ & >120 kg Patients >120 kg had small increased risk of gastrointestinal bleed Dabigatran use in patients >120 kg is reasonable