AVERROES
Trial question
What is the role of apixaban in patients with AF who are at an increased risk for stroke for whom VKA therapy is unsuitable?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
41.0% female
59.0% male
N = 5599
5599 patients (2322 female, 3277 male)
Inclusion criteria: patients with AF who were at increased risk for stroke and for whom VKA therapy was unsuitable
Key exclusion criteria: valvular disease requiring surgery, a serious bleeding event in the previous 6 months or a high risk of bleeding, current alcohol or drug abuse or psychosocial issues, life expectancy < 1 year, or severe renal insufficiency
Interventions
N=2808 apixaban (5 mg PO BID)
N=2791 aspirin (81-324 mg PO once daily)
Primary outcome
Incidence of stroke or systemic embolism
1.6
3.7
3.7 % / y
2.8 % / y
1.9 % / y
0.9 % / y
0.0 % / y
Apixaban
Aspirin
Significant decrease ▼
Significant decrease in the incidence of stroke or systemic embolism (1.6% / y vs. 3.7% / y; HR 0.45, 95% CI 0.32 to 0.62)
Secondary outcomes
No significant difference in death (3.5% vs. 4.4%; HR 0.79, 95% CI 0.62 to 1.02)
Significant decrease in hospitalization for cardiovascular causes (12.6% vs. 15.9%; HR 0.79, 95% CI 0.69 to 0.91)
Safety outcomes
No significant differences in major bleeding (1.4% vs. 1.2%, p=0.57; HR 1.13, 95% CI 0.74-1.75).
Significant differences in serious adverse event (22% vs. 27%, p < 0.001).
Conclusion
In patients with AF who were at increased risk for stroke and for whom VKA therapy was unsuitable, apixaban was superior to aspirin with respect to the incidence of stroke or systemic embolism.
Reference
Connolly SJ, Eikelboom J, Joyner C et al. Apixaban in patients with atrial fibrillation. N Engl J Med. 2011 Mar 3;364(9):806-17.
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