AUGUSTUS (anticoagulation regimen)
Trial question
Is apixaban superior to VKA in patients with AF and acute coronary syndrome or PCI?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
29.0% female
71.0% male
N = 4614
4614 patients (1337 female, 3277 male)
Inclusion criteria: patients with AF who had acute coronary syndrome or had undergone PCI
Key exclusion criteria: anticoagulation therapy for other conditions; severe renal insufficiency; ICH; CABG surgery; coagulopathy or ongoing bleeding
Interventions
N=2306 apixaban (at a dose of 2.5-5 mg PO BID)
N=2308 VKA (tablets once daily adjusted to reach a target INR of 2.0-3.0)
Primary outcome
Major or clinically relevant nonmajor bleeding
10.5
14.7
14.7 %
11.0 %
7.3 %
3.7 %
0.0 %
Apixaban
Vitamin K antagonist
Significant decrease ▼
NNT = 23
Significant decrease in major or clinically relevant nonmajor bleeding (10.5% vs. 14.7%; HR 0.69, 95% CI 0.58 to 0.81)
Secondary outcomes
Significant decrease in death or hospitalization (23.5% vs. 27.4%; HR 0.83, 95% CI 0.74 to 0.93)
No significant difference in death or ischemic event (6.7% vs. 7.1%; HR 0.93, 95% CI 0.75 to 1.16)
No significant difference in death (3.3% vs. 3.2%; HR 1.03, 95% CI 0.75 to 1.42)
Safety outcomes
No significant difference in ICH.
Significant differences in major bleeding (3.0% vs. 4.6%), clinically relevant nonmajor bleeding (7.9% vs. 10.9%).
Conclusion
In patients with AF who had acute coronary syndrome or had undergone PCI, apixaban was superior to VKA with respect to major or clinically relevant nonmajor bleeding.
Reference
Renato D Lopes, Gretchen Heizer, Ronald Aronson et al. Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation. N Engl J Med. 2019 Apr 18;380(16):1509-1524.
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