Using primary care data to assess comparative effectiveness and safety of apixaban and rivaroxaban in patients with nonvalvular atrial fibrillation in the UK: an observational cohort study

Abstract

ObjectiveTo compare real-world effectiveness and safety of direct oral anticoagulants (DOACs) in patients with nonvalvular atrial fibrillation (AFib) for prevention of stroke.Study design and settingA comparative cohort study in UK general practice data from The Health Improvement Network database.Participants and interventionsBefore matching, 5655 patients ≥18 years with nonvalvular AFib who initiated at least one DOAC between 1 July 2014 and 31 December 2020 were included. DOACs of interest included apixaban, rivaroxaban, edoxaban and dabigatran, with the primary comparison between apixaban and rivaroxaban. Initiators of DOACs were defined as new users with no record of prescription for any DOAC during 12 months before index date.Primary and secondary outcome measuresThe primary outcome was stroke (ischaemic or haemorrhagic). Secondary outcomes included the occurrence of all-cause mortality, myocardial infarction (MI), transient ischaemic attacks (TIA), major bleeding events and a composite angina/MI/stroke (AMS) endpoint.ResultsCompared with rivaroxaban, patients initiating apixaban showed similar rates of stroke (HR: 0.93; 95% CI 0.64 to 1.34), all-cause mortality (HR: 1.03; 95% CI 0.87 to 1.22), MI (HR: 0.95; 95% CI 0.54 to 1.68), TIA (HR: 1.03; 95% CI 0.61 to 1.72) and AMS (HR: 0.96; 95% CI 0.72 to 1.27). Apixaban initiators showed lower rates of major bleeding events (HR: 0.60; 95% CI 0.47 to 0.75).ConclusionsAmong patients with nonvalvular AFib, apixaban was as effective as rivaroxaban in reducing rate of stroke and safer in terms of major bleeding episodes. This head-to-head comparison supports conclusions drawn from indirect comparisons of DOAC trials against warfarin and demonstrates the potential for real-world evidence to fill evidence gaps and reduce uncertainty in both health technology assessment decision-making and clinical guideline development.

Effectiveness and safety of oral anticoagulants for non-valvular atrial fibrillation: a population-based cohort study in primary healthcare in Catalonia

“…Regarding these patients with a prior history of stroke, it is necessary to highlight the critical role of this factor in predicting future stroke risk. Other authors have described stroke rates based on similar categories and found heterogeneous results ( Bengtson et al, 2017 ; Rodríguez-Bernal et al, 2021 ; Jaksa et al, 2022 ). For DOAC-treated, adherence showed a protective effect against stroke, in line with similar studies with DOAC ( Yao et al, 2016a ; Deshpande et al, 2018 ).…”

“…In their pivotal randomized clinical trials, all DOAC demonstrated to be at least non-inferior to warfarin in stroke prevention ( Connolly et al, 2009 ; Granger et al, 2011 ; Patel et al, 2011 ; Giugliano et al, 2013 ). In recent years, multiple observational studies have analysed effectiveness and safety of DOAC in comparison to warfarin and coumarins ( Anguita Sánchez et al, 2020 ; Durand et al, 2020 ; Lee et al, 2020 ; Crocetti et al, 2021 ; Lip et al, 2021 ; Grymonprez et al, 2023 ), between different DOAC ( Rutherford et al, 2020 ; Jaksa et al, 2022 ; Talmor-Barkan et al, 2022 ), or in certain population subgroups of interest ( Bang et al, 2020 ; Costa et al, 2020 ; Rodríguez-Bernal et al, 2021 ). Some studies have also assessed these outcomes based on the dose of DOAC or the adherence to treatment ( Deshpande et al, 2018 ; Staerk et al, 2018 ; Kohsaka et al, 2020 ), considering that adequate levels of adherence have shown to decrease the occurrence of thromboembolic events ( Amin and Marrs, 2015 ; Yao et al, 2016a ).…”

AF-React study: Prevalence of thrombotic events in patients with atrial fibrillation receiving NOACs – real-world data analysis from northern Portugal primary healthcare

“…Another study comparing the safety and efficacy of apixaban vs. rivaroxaban for stroke prevention in patients with AF concluded that an increased preference for rivaroxaban was significantly associated with a higher risk of major bleeding but not stroke (23). Similarly, a study in UK general practice comparing the real-world effectiveness and safety of direct oral anticoagulants in patients with non-valvular AF to prevent stroke found that apixaban was as effective as rivaroxaban in reducing the rate of stroke (24).…”

Rivaroxaban Versus Apixaban: A Comparison Without a Simple Solution

“…A total of 339 studies were initially identified of which 230 studies were excluded based on the exclusion criteria. On review of the remaining 109 studies, full texts were reviewed, and 41 studies were included for final review 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 ( Figure 1 ). Not all studies reviewed are referenced further.…”