Study Evaluates DOACs in the Context of Major Bleeding
When compared with warfarin, apixaban in small doses may increase mortality risk in patients with and without atrial fibrillation (AF), according to results of a new analysis.
To evaluate the effect of anticoagulation therapy on the risks for bleeding and all-cause mortality, the researchers assessed nearly 200,000 patients with and without AF who initiated anticoagulation therapy in the United Kingdom between 2011 and 2016.
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“[AF] is the most common condition requiring anticoagulants, and most clinical trial evidence has been based on this group of patients,” the researchers write. “These trials have established non-inferiority in the anticoagulating qualities of [direct oral anticoagulants] compared with warfarin in controlled trial settings, but there are residual concerns regarding their safety, particularly in more real-world settings, where they are prescribed to a broad range of patients.”
Primary outcomes measured were major bleeding events leading to hospital admission or death. Also considered in data analysis were sites of bleeding and all-cause mortality.
Findings suggest that apixaban decreased the risk for major bleeding events and intracranial bleeding in patients with AF compared with warfarin. For patients without AF, apixaban decreased the risk for major bleeding, any gastrointestinal bleeding, and upper gastrointestinal bleeding. However, for patients with and without AF who were on lower doses of apixaban, there was an increased risk for all-cause mortality compared with warfarin.
In patients with AF, dabigatran decreased the risk for intracranial bleeding, but rivaroxaban increased the risk for all-cause mortality compared with warfarin.
In patients without AF, rivaroxaban decreased the risk for intracranial bleeding but increased the risk for all-cause mortality compared with warfarin.
“This large observational study, based on a general population in a primary care setting, provides reassurance about the safety of [direct oral anticoagulants] as an alternative to warfarin across all new incident users,” the researchers conclude.
“Our results give an initial, reassuring, indication of the risk patterns for all patients taking anticoagulants, with respect to those prescribed apixaban.”
Vinogradova Y, Coupland C, Hill T, Hippisley-Cox J. Risks and benefits of direct oral anticoagulants versus warfarin in a real world setting: cohort study in primary care [published online July 4, 2018]. BMJ. https://doi.org/10.1136/bmj.k2505.