Most patients enrolled in the Global Anticoagulant Registry in the FIELD-AF (GARFIELD-AF) received the recommended doses of direct oral anticoagulants (DOACs) according to country-specific guidelines, according to a study published Sept. 14 in the Journal of the American College of Cardiology. Prescription of non-recommended doses was associated with an increased risk of death, mostly cardiovascular death, compared with patients on recommended doses.

Alan John Camm, MD, FACC, et al., sought to assess the dosing patterns of DOAC prescription and the impact of regulatory and guideline recommended vs. non-recommended DOAC dosing on the rate of events at the two-year follow-up in patients with newly diagnosed atrial fibrillation.

Of the 34,926 patients enrolled in GARFIELD-AF, 10,426 received a DOAC. Of these 10,426 patients, 72.9% received recommended dosing, 23.2% were underdosed and 3.8% were overdosed. Non-recommended dosing was associated with a higher risk of all-cause mortality. The risk of stroke/systemic embolism and major bleeding was not significantly different based on the level of dosing.

"Treatment above the recommended doses was relatively rare compared with non-recommended dosing," write the authors of the study. "Of those who were treated over the recommended doses, 67.5% had moderate to severe [chronic kidney disease], as opposed to 8.6% of patients with recommended dosing and 7.1% of patients with underdosing. The highest risk patients were more prone to receive non-recommended doses of DOACs."

"Treating patients is an art and clinicians may rarely need to individualize a treatment for a given patient," writes Gerald V. Naccarelli, MD, FACC, in an accompanying editorial comment. "However, the clinician should be careful with the art of practice. Ignoring the truth of the well-studied and [recommended] doses of DOACs can lead to dangerous consequences. The truth is that these doses have not been well-studied and exposes patients to thromboembolic events leading to a stroke. Primum non-nocere (first do no harm) is part of the original Hippocratic oath. Under-dosing of a DOAC may break this tenet."

Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Anticoagulation Management and Atrial Fibrillation, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: Anticoagulants, Atrial Fibrillation, Hippocratic Oath, Administration, Oral, Follow-Up Studies, Stroke, Thromboembolism, Hemorrhage, Registries, Renal Insufficiency, Chronic, Cardiology, Embolism

< Back to Listings