6/28/23, 12:48 AM AUGUSTUS (antiplatelet regimen) Pathway Feedback Search Clinical Topics Home Studies AUGUSTUS (antiplatelet regimen) AUGUSTUS (antiplatelet regimen) Disease Disease Disease Atrial fibrillation Non-ST-elevation myocardial inf ST-elevat 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 N = 4614 71.0% male 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; intracranial hemorrhage; 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 % 16.1 https://web.pathway.md/studies/recUsGNqQDoria1Hc 1/2 6/28/23, 12:48 AM AUGUSTUS (antiplatelet regimen) Pathway 6 12.1 % 9 8.1 % Significant increase 4.0 % NNH = 14 0.0 % Aspirin Placebo 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 intracranial hemorrhage, 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. Open reference URL https://web.pathway.md/studies/recUsGNqQDoria1Hc 2/2