March 30, 2020
Secondary Analysis of AUGUSTUS Seeks Optimal Duration of Aspirin After ACS or PCI In Patients With Atrial Fibrillation
March 30, 2020—John H. Alexander, MD, presented findings from a secondary analysis of the AUGUSTUS study that suggests that the use of aspirin acutely and for approximately 30 days after acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) provides the greatest net clinical benefit for patients with atrial fibrillation (AF) requiring anticoagulation.
Previously, AUGUSTUS showed that patients with AF and a recent ACS or PCI had less bleeding with placebo compared with aspirin. There were, however, numerically higher rates of ischemic events in patients assigned to placebo. The aim of this analysis is to assess the balance of risk (bleeding) and benefit (ischemic events) over time with aspirin versus placebo.
The data were revealed as a Featured Clinical Research presentation at the virtual conference of the American College of Cardiology's Annual Scientific Session Together with the World Congress of Cardiology (ACC.20/WCC).
As summarized in the ACC.20/WCC abstract, the AUGUSTUS study was composed of 4,614 patients with AF and recent ACS or PCI on a P2Y12 inhibitor who were randomized to blinded aspirin or placebo and to open-label apixaban or warfarin for 6 months. Most patients received aspirin acutely before randomization, which occurred a median of 6 days after ACS or PCI.
In the post-hoc analysis, Dr. Alexander and colleagues compared Kaplan Meier rates of International Society on Thrombosis and Hemostasis (ISTH) major bleeding and the composite of cardiovascular (CV) death, myocardial infarction (MI), definite or probable stent thrombosis, or stroke in patients assigned to aspirin and placebo from randomization through 30 days and from 30 days to 6 months.
The investigators reported the following:
- From randomization to 30 days, rates of major bleeding were 2.11% with aspirin and 1.14% with placebo (absolute difference 0.97%; 95% confidence interval [CI], 0.23–1.70) and rates of CV death, MI, stent thrombosis, or stroke were 1.66 with aspirin and 2.57 with placebo (absolute difference -0.91%; 95% CI, -1.74–-0.08).
- From 30 days to 6 months, rates of major bleeding were 3.71% with aspirin and 2.45% with placebo (absolute difference 1.25%; 95% CI, 0.23–2.27) and rates of CV death, MI, stent thrombosis, or stroke were 3.82% with aspirin and 3.99% with placebo (absolute difference -0.17%; 95% CI, -1.33–0.98).
In patients with AF and recent ACS/PCI receiving a P2Y12 inhibitor and oral anticoagulation, the use of aspirin acutely and for up to 30 days resulted in a balanced tradeoff between a reduction in serious ischemic events and increase in major bleeding. After 30 days, aspirin continued to increase bleeding without reducing ischemic events. These findings suggest that the use of aspirin acutely and for approximately 30 days after ACS/PCI provides the greatest net clinical benefit for patients with AF requiring anticoagulation, concluded the investigators at ACC.20/WCC.