AUGUSTUS (antiplatelet regimen)
Trial question
What is the role of aspirin in patients with AF and acute coronary syndrome or PCI?
Study design
Multi-center
Double blinded
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=2307 aspirin (81 mg acetylsalicylic acid tablet PO once daily)
N=2307 placebo (matching placebo once daily)
Primary outcome
Major or clinically relevant nonmajor bleeding
16.1
9
16.1 %
12.1 %
8.1 %
4.0 %
0.0 %
Aspirin
Placebo
Significant increase ▲
NNH = 14
Significant increase in major or clinically relevant nonmajor bleeding (16.1% vs. 9%; HR 1.89, 95% CI 1.59 to 2.24)
Secondary outcomes
No significant difference in death or hospitalization (26.2% vs. 24.7%; HR 1.08, 95% CI 0.96 to 1.21)
No significant difference in death or ischemic event (6.5% vs. 7.3%; HR 0.89, 95% CI 0.71 to 1.11)
No significant difference in death (3.1% vs. 3.4%; HR 0.91, 95% CI 0.66 to 1.26)
Safety outcomes
No significant differences in ICH, severe bleeding.
Significant differences in major bleeding (4.7% vs. 2.9%), clinically relevant nonmajor bleeding (12.1% vs. 6.5%).
Conclusion
In patients with AF who had acute coronary syndrome or had undergone PCI, aspirin was inferior to placebo 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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