Apixaban Versus Warfarin in Patients with AF and ACS or PCI: The AUGUSTUS Trial Exclusion • Contraindication to DAPT • Other reason for warfarin (prosthetic valve, mod/sev MS) • Inclusion • AF (prior, persistent, or >6 hrs duration) • Physician decision that oral anticoag is indicated • ACS and/or PCI with planned P2Y12 inhibitor for 6 months Randomize n =4,600 Patients Apixaban Warfarin P2Y12 inhibitor for all patients x 6 months Aspirin for all on the day of ACS or PCI Aspirin versus placebo after randomization ASA ASA placebo placebo Primary outcome: major/clinically relevant bleeding (through 6 months) Secondary objective: Death, MI, stroke, stent thrombosis
The AUGUSTUS Trial • A real-world, logistically easy trial, with reduced SAE reporting, risk based monitoring and minimal in-person visits, with local labs • Study Design • 4600 participants, 650 sites, 30 countries • 2x2 factorial design comparing • Open Label apixaban 5 mg BID vs warfarin (INR 2-3) • Blinded aspirin vs aspirin-placebo
The AUGUSTUS TrialStudy Design Two Primary Hypotheses (2 x 2 factorial) • Apixaban is non-inferior to warfarin on ISTH major or clinically relevant non-major bleeding in patients with AF who develop ACS and/or undergo PCI with planned antiplatelet therapy. • Single antiplatelet therapy with a P2Y12 inhibitor is superior to dual antiplatelet therapy with a P2Y12 inhibitor and aspirin on ISTH major bleeding or clinically relevant non-major bleeding in patients with AF who develop ACS and/or undergo PCI with concomitant antiplatelet therapy.
The AUGUSTUS TrialInclusion / Exclusion Criteria • Inclusion criteria • Age >=18 years with atrial fibrillation/flutter with planned use of oral anticoagulant • ACS event and/or PCI with stent within past 2 weeks • Planned P2Y12 inhibitor use for at least 6 months • Exclusion Criteria • Serum Cr >2.5 mg/dL or CrCl< 30mL/min • Other conditions (e.g. DVT or mechanical valves) that require chronic anticoagulation • History of intracranial bleeding • Known bleeding or known contraindications to anticoagulation • CABG (planned or completed) for index ACS event