Bleeding risk with apixaban and dabigatran similar to aspirin, suggests study

A systematic review and meta-analysis estimating the differences in bleeding risks between therapeutic-dose non-vitamin K oral anticoagulants (NOACs) and single antiplatelet therapy (aspirin) found that rates of major bleeding for therapeutic-dose apixaban and dabigatran were similar to low-dose aspirin, but rates were higher for rivaroxaban. These findings can help patients with atrial fibrillation (AF) and clinicians better understand the bleeding risks associated with anticoagulants versus aspirin. The study is published in Annals of Internal Medicine.

Researchers from McMaster University and colleagues studied data from nine randomized controlled trials with 26,224 patients comparing bleeding risks of therapeutic-dose NOACs to single antiplatelet therapy. Included RCTs had a minimum treatment duration of three months and studies assessing low-dose NOACs and using two or more antithrombotic therapies were excluded. Patients in the included trials were characterized as having a recent history of stroke, history of clinical AF and intracranial hemorrhage, history of AF considered unsuitable for vitamin K antagonist therapy, subclinical AF detected on pacemakers and defibrillators, and venous thromboembolism after six to twelve months of initial anticoagulation. The NOACs studied in the included trials were apixaban, rivaroxaban and dabigatran. All trials used aspirin as the single antiplatelet therapy studied. The main outcomes were major bleeding and intracranial bleeding, and other outcomes included fatal, gastrointestinal, clinically relevant nonmajor and minor bleeding.

The researchers found that 2.16% of patients had major bleeding and .66% had intracranial hemorrhage. The absolute risks for both major bleeding and intracranial hemorrhage were similar for therapeutic dose apixaban and dabigatran compared to aspirin but higher with rivaroxaban use than with aspirin. These findings can help ease challenges physicians face in accurately balancing the risks and benefits of prescribing NOACs versus aspirin for patients with AF.

Reference:

Michael Ke Wang, Geethan Baskaran, Ghazal Razeghi, et al. Bleeding Risks With Non–Vitamin K Oral Anticoagulants Versus Single Antiplatelet Therapy: A Systematic Review and Meta-analysis of Randomized Trials. Ann Intern Med. [Epub 11 February 2025]. doi:10.7326/ANNALS-24-02132