TABLE 2.
The Risks and Benefits of Direct Oral Anticoagulants With Warfarin in Elderly Patients With Nonvalvular Atrial Fibrillation
| Anticoagulants (Ref. #) | Parent Trial | Proportion of Very Elderly Patients | Efficacy | Risk |
|---|---|---|---|---|
| Dabigatran vs. warfarin (60) | RE-LY (n = 18,113) | 16.7% ≥80 yrs (n = 3,025) | 150 mg bid: Trend toward lower risk of stroke or systemic embolism with dabigatran in age ≥85 yrs Lower risk of stroke or systemic embolism in age <75 yrs 110 mg bid: Trend toward lower risk of stroke or systemic embolism with dabigatran in patients age <75 and ≥85 yrs |
Major extracranial bleeding 150 mg bid: Higher risk with dabigatran in ≥80 yrs of age* (HR 1.68) Lower risk with dabigatran in younger patients 110 mg bid: No difference in ≥80 yrs Lower with dabigatran in younger patients Major intracranial hemorrhage 150 or 110 mg bid: Trend toward lower risk with dabigatran in age ≥85 yrs Lower risk with dabigatran in age <75 yrs |
| Apixaban†‡ vs. warfarin (57) | ARISTOTLE (n = 18,201) | 13% ≥80 yrs (n = 2,436) | Lower risk of stroke or systemic embolism with apixaban in all age groups | Lower risk of major bleeding and intracranial bleeding with apixaban in all age groups |
| Rivaroxaban§ vs. warfarin (58) | ROCKET AF (n = 14,276) | 44% ≥75 yrs (n = 6,229) 4.6% ≥85 yrs (n = 663) |
No difference in the risk of stroke or systemic embolism in all age groups | No difference in major bleeding or hemorrhagic stroke in all age groups |
| Edoxaban vs. warfarin (59) | ENGAGE AF-TIMI 48 (n = 21,105) | 17% ≥80 yrs (n = 3,591) | No difference in the risk of stroke or systemic embolism in all age groups | Lower major bleeding or intracranial hemorrhage with edoxaban in all age groups |
p value significant for age-treatment interaction.
The 2.5 mg twice daily (bid) dose was used in the study if patients had at least 2 of the following factors: ≥80 years of age, weight ≥60 kg, and creatinine >1.5 mg/dl.
69% of patients age ≥80 years received 5 mg bid and 31% received 2.5 mg bid per pre-specified criteria.
Dose of rivaroxaban 20 mg daily, or 15 mg daily if glomerular filtration rate (GFR) <50 ml/min.
ARISTOTLE = Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation; ENGAGE AF-TIMI = Effective aNticoaGulation with factor Xa next GEneration in Atrial Fibrillation-Thrombolysis In Myocardial Infarction; RE-LY = Randomized Evaluation of Long-Term Anticoagulant Therapy; ROCKET AF = Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation.