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September 26, 2019

AUGUSTUS Compares Antithrombetic Therapies in Patients Treated for AF and ACS

September 26, 2019—Insights from the AUGUSTUS ACS trial were published by Stephan Windecker, MD, et al in Circulation simultaneous with Dr. Windecker's presentation of the study at TCT 2019, the 31st annual Transcatheter Cardiovascular Therapeutics scientific symposium, held September 25–29 in San Francisco, California.

AUGUSTUS ACS is an evaluation of the safety and efficacy of antithrombotic therapy in patients with atrial fibrillation (AF) and acute coronary syndrome (ACS) treated medically or with percutaneous coronary intervention (PCI) or undergoing elective PCI.

As summarized in Circulation, the investigators used a 2 X 2 factorial design to compare apixaban with vitamin K antagonists (VKA) and aspirin with placebo in patients with AF who had ACS or were undergoing PCI and were receiving a P2Y12 inhibitor. The study measured bleeding, death, and hospitalization as well as death and ischemic events by antithrombotic strategy in three prespecified subgroups: patients with ACS treated medically, ACS treated with PCI, and those undergoing elective PCI.

Of 4,614 patients enrolled, 1,097 (23.9%) had ACS treated medically; 1,714 (37.3%) had ACS treated with PCI; and 1,784 (38.8%) had elective PCI.

The AUGUSTUS ACS investigators found the following:

  • Apixaban compared with VKA reduced major bleeding (per definition of International Society on Thrombosis and Hemostasis) or clinically relevant nonmajor bleeding in patients with ACS treated medically (hazard ratio [HR], 0.44; 95% confidence interval [CI], 0.28–0.68); ACS treated with PCI (HR, 0.68; 95% CI, 0.52–0.89); and undergoing elective PCI (HR, 0.82; 95% CI, 0.64–1.04) (Pinteraction = .052).
  • Apixaban compared with VKA reduced death or hospitalization in ACS treated medically (HR, 0.71; 95% CI, 0.54–0.92); ACS treated with PCI (HR, 0.88; 95% CI, 0.74–1.06); and elective PCI (HR, 0.87; 95% CI, 0.72–1.04) (Pinteraction = .345).
  • Apixaban compared with VKA resulted in a similar effect on death and ischemic events in the ACS treated medically, ACS treated with PCI, and elective PCI groups (Pinteraction = .356).
  • Compared with placebo, aspirin had a higher rate of bleeding than placebo in patients with ACS treated medically (HR, 1.49; 95% CI, 0.98–2.26), ACS treated with PCI (HR, 2.02; 95% CI, 1.53–2.67) and elective PCI groups (HR, 1.91; 95% CI, 1.48–2.47) (Pinteraction = .479).
  • For placebo compared with aspirin, there was no difference in outcomes among the three groups for the composite of death or hospitalization (Pinteraction = .787) and death and ischemic events (Pinteraction = .71).

The antithrombotic regimen consisting of apixaban and a P2Y12 inhibitor without aspirin provides superior safety and similar efficacy in patients with AF who have ACS, whether managed medically or with PCI, or those undergoing elective PCI than regimens that include VKAs, aspirin, or both, concluded the AUGUSTUS ACS investigators in Circulation.

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