IMPORTANCE Patients with nonvalvular atrial fibrillation at risk of stroke should receive oral anticoagulants (OAC). However, approximately 1 in 8 patients in the Global Anticoagulant Registry in the Field (GARFIELD-AF) registry are treated with antiplatelet (AP) drugs in addition to OAC, with or without documented vascular disease or other indications for AP therapy. OBJECTIVE To investigate baseline characteristics and outcomes of patients who were prescribed OAC plus AP therapy vs OAC alone.
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.
Purpose: Describe patient characteristics, pregnancy outcomes,
and infant outcomes among pregnant patients and their linked infants in
the novel Maternal Outcomes Masterset (MOM). Methods: We used
closed claims within the MOM data to identify publicly and
privately-insured patients at first record of pregnancy
1/1/2018-12/1/2021 with ≥180 days baseline enrollment. We described
characteristics during baseline and follow-up (until an observed
pregnancy endpoint, disenrollment, or 42-week maximum). We described
maternal and infant characteristics overall and by infant linkage.
Results: Among 1,438,861 pregnant patients meeting the study
criteria, the most common pregnancy endpoint recorded was live birth
(42%) followed by spontaneous abortion (14%). Among 602,721 patients
with a live birth, 99% had a week-specific gestational age recorded and
35% had at least one linked infant. Patients with infant linkage and
sufficient follow-up (N=155,621) had similar baseline comorbidities,
pregnancy complications, and gestational age at delivery versus those
without any linkage. However, more patients with linkage had commercial
coverage (70% vs 31%), and were therefore older (50% vs 31% aged ≥30
years) and more likely to have unknown race (57% vs 34%).
Conclusions: In this large sample of pregnant patients,
maternal and infant characteristics generally align with national
statistics, providing confidence in the use of this novel data source
for pregnancy research. Further, confirmation that the subset of
patients with infant linkage is similar to the overall pregnancy cohort
provides assurance that this subset can be considered representative.
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