ARISTOTLE
Trial question
What is the role of apixaban in patients with AF?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 18201
18201 patients (6416 female, 11785 male)
Inclusion criteria: patients with AF and at least one additional risk factor for stroke
Key exclusion criteria: AF due to a reversible cause, moderate or severe MS, conditions other than AF that required anticoagulation (e.g., a prosthetic heart valve), stroke within the previous 7 days, need for aspirin at a dose of > 165 mg a day or for both aspirin and clopidogrel, and severe renal insufficiency
Interventions
N=9120 apixaban (5 mg PO BID)
N=9081 warfarin (dose-adjusted, with target INR 2.0 to 3.0)
Primary outcome
Incidence of ischemic or hemorrhagic stroke or systemic embolism
1.2
1.6
1.6 % / y
1.2 % / y
0.8 % / y
0.4 % / y
0.0 % / y
Apixaban
Warfarin
Significant decrease ▼
Significant decrease in the incidence of ischemic or hemorrhagic stroke or systemic embolism (1.2% / y vs. 1.6% / y; HR 0.79, 95% CI 0.66 to 0.95)
Secondary outcomes
Significant decrease in the incidence of major bleeding (2.13% / y vs. 3.09% / y; HR 0.69, 95% CI 0.6 to 0.8)
Significant decrease in death from any cause (3.52% vs. 3.94%; HR 0.89, 95% CI 0.8 to 0.99)
Significant decrease in the incidence of hemorrhagic stroke (0.24% / y vs. 0.47% / y; HR 0.51, 95% CI 0.35 to 0.75)
Safety outcomes
No significant difference in adverse events (81.5% vs. 83.1%) and serious adverse events (35.0% vs. 36.5%).
Conclusion
In patients with AF and at least one additional risk factor for stroke, apixaban was superior to warfarin with respect to the incidence of ischemic or hemorrhagic stroke or systemic embolism.
Reference
Granger CB, Alexander JH, McMurray JJ et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011 Sep 15;365(11):981-92.
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