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Safety and Effectiveness of Oral Anticoagulants in AF
Quick Takes
- Analysis from a French national claims database demonstrated improved safety and effectiveness outcomes for apixaban versus VKA for stroke prevention in AF.
- Apixaban was found to have less bleeding but similar rates of stroke as rivaroxaban in this analysis of patients with AF.
- Apixaban and dabigatran demonstrated similar safety and efficacy outcomes for stroke prevention in AF in this French national claims analysis.
Study Questions:
What is the comparative safety, efficacy, and mortality of apixaban as compared to other oral anticoagulants when used for stroke prevention in patients with atrial fibrillation (AF)?
Methods:
NAXOS (Evaluation of Apixaban in Stroke and Systemic Embolism Prevention in Patients With Nonvalvular Atrial Fibrillation) is an observational study using the French National Health System claims database; all adults with nonvalvular AF who newly initiated an oral anticoagulant between 2014 and 2016 were identified. Outcomes of interest were major bleeding that required hospitalization (safety), stroke and systemic thromboembolism (effectiveness), and all-cause mortality. Patients initiated on various oral anticoagulants were compared using four different methods, including propensity score matching, propensity score adjustment, and regression analysis adjusting for known confounders. Cumulative incidence rates accounting for death as a competing risk were calculated.
Results:
Among 321,501 patients, use of different oral anticoagulants included vitamin K antagonists (VKAs; 35.0%), apixaban (27.2%), rivaroxaban (31.1%), and dabigatran (6.6%). Apixaban use was associated with a lower risk of major bleeding that required hospitalization as compared to VKAs (4.00% vs. 9.54%, hazard ratio [HR], 0.43; 95% confidence interval [CI], 0.40-0.46) and rivaroxaban (4.24% vs. 6.38%, HR, 0.67; 95% CI, 0.63-0.72), but not dabigatran (3.80% vs. 4.31%, HR, 0.93; 95% CI, 0.81-1.08). Apixaban was also associated with a lower risk of stroke and systemic embolism as compared to VKAs (3.16% vs. 6.13%, HR, 0.60; 95% CI, 0.56-0.65), but not rivaroxaban (2.93% vs. 3.22%, HR, 1.05; 95% CI, 0.97-1.15) or dabigatran (2.56% vs. 3.28%, HR, 0.93; 95% CI, 0.78-1.11). Apixaban was also associated with a lower risk of all-cause mortality than VKAs (11.10% vs. 26.55%, HR, 0.42; 95% CI, 0.42-0.45), but not rivaroxaban (9.18% vs. 9.66%, HR, 0.79; 95% CI, 0.93-1.02) or dabigatran (8.36% vs. 10.05%, HR, 0.94; 95% CI, 0.85-1.04).
Conclusions:
The authors concluded that apixaban was associated with superior safety, effectiveness, and lower mortality than VKAs; superior safety but similar effectiveness to rivaroxaban; and similar safety and effectiveness as dabigatran.
Perspective:
Building on the robust clinical trial experience comparing different direct oral anticoagulants (DOACs) to VKAs for stroke prevention in AF, numerous large observational studies have compared outcomes between individual DOACs and VKA as well as between different DOACs. This nationwide French study largely confirms prior analyses comparing safety and effectiveness of apixaban as compared to VKAs. While some prior studies have found safety advantage with similar effectiveness or similar safety with improved effectiveness for apixaban versus VKA, this analysis found both outcomes to be improved among apixaban-treated patients. Despite lacking data on VKA control or dose selection of individual DOACs, this analysis provides further reassurance that DOACs as a class should be first-line therapies for patients with AF. For many patients, the potential safety and/or effectiveness benefits of apixaban as compared to either rivaroxaban or dabigatran make it the first-line DOAC for stroke prevention in AF.
Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Geriatric Cardiology, Prevention, Anticoagulation Management and Atrial Fibrillation, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias
Keywords: Anticoagulants, Arrhythmias, Cardiac, Atrial Fibrillation, Embolism, Geriatrics, Hemorrhage, Secondary Prevention, Stroke, Thromboembolism, Vascular Diseases, Vitamin K
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