6/28/23, 12:48 AM AUGUSTUS (anticoagulation regimen) Pathway Feedback Search Clinical Topics Home Studies AUGUSTUS (anticoagulation regimen) AUGUSTUS (anticoagulation regimen) Disease Disease Disease Atrial fibrillation Non-ST-elevation myocardial inf ST-elevat Trial question Is apixaban superior to vitamin K antagonist 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 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=2306 apixaban (at a dose of 2.5-5 mg PO BID) N=2308 vitamin K antagonist (tablets once daily adjusted to reach a target INR of 2.0-3.0) Primary outcome Major or clinically relevant nonmajor bleeding https://web.pathway.md/studies/rec2rEL8qcehO4W88 1/2 6/28/23, 12:48 AM AUGUSTUS (anticoagulation regimen) Pathway 14.7 % 14.7 11.0 % 10.5 7.3 % Significant decrease 3.7 % NNT = 24 0.0 % Apixaban Vitamin K antagonist 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 intracranial hemorrhage. 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 vitamin K antagonist 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/rec2rEL8qcehO4W88 2/2