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Why the study?
Limited data exist on the optimal antithrombotic strategy to minimize total bleeding and ischemic events in patients with recent ACS or PCI and AF.
Does apixaban and aspirin compared to VKA and placebo affect total bleeding, ischemic events, and hospitalizations in patients with AF and recent ACS or PCI on P2Y12 inhibitors?
RCT (n=4,614)
Open-label
2x2 factorial
Does apixaban and aspirin compared to VKA and placebo affect total bleeding, ischemic events, and hospitalizations in patients with AF and recent ACS or PCI on P2Y12 inhibitors?
Relative Risk: 0.66 (95% CI 0.55–0.8)
In patients with AF and recent ACS or PCI, a regimen of apixaban and a P2Y12 inhibitor without aspirin minimizes total bleeding events without significantly increasing ischemic events.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Now, [we show] this is the safest and the most efficacious strategy for a composite endpoint that includes cardiovascular hospitalizations, bleeding, and all cause deaths. These positive results were driven primarily because of less bleeding, but also went in the same direction for cardiovascular hospitalizations.... It was good to see the results were aligned with the primary AUGUSTUS result but expanded now for a combination of bleeding and cardiovascular hospitalizations.”
“It makes the case for the so-called default strategy where most patients can be managed with dual therapy when they head home from the hospital.”
“When you look at the totality of data now, I think in this clinical setting of atrial fibrillation and ACS or PCI, less might be more. I think that's the key message.”
Apixaban plus P2Y12 inhibitor without aspirin may minimize total events in AF after ACS/PCI; leaves open need for prospective validation beyond this analysis.
BACKGROUND Limited data exist on the optimal antithrombotic strategy to minimize total bleeding and ischemic events for patients with recent acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) and atrial fibrillation (AF). OBJECTIVES The authors sought to identify the antithrombotic regimen that minimized total major or clinically relevant nonmajor bleeding events, ischemic events, and hospitalizations after ACS or PCI in AF. METHODS We conducted a secondary analysis of AUGUSTUS (Open-label, 2×2 Factorial, Randomized, Controlled Clinical Trial to Evaluate the Safety of Apixaban vs Vitamin K Antagonist and Aspirin vs Placebo in Patients with Atrial Fibrillation and Acute Coronary Syndrome and/or Percutaneous Coronary Intervention), a 2×2 factorial, randomized trial evaluating apixaban vs a vitamin K antagonist (VKA) and aspirin vs placebo in patients with AF and ACS or PCI who were on P2Y12 inhibitor therapy. We determined the incidence of total major or clinically relevant nonmajor bleeding events in patients receiving at least 1 dose of study therapy, total ischemic events, and total hospitalizations among patients randomized to each antithrombotic strategy. RESULTS Over 6 months of follow-up, 573 of 4,568 (12.5%) patients experienced at least 1 bleeding event while on study drug; among them, 110 (19.2%) had multiple bleeding events. Compared with those with 1 bleeding event, patients with multiple bleeding events were more likely to be on a high-potency P2Y12 inhibitor (prasugrel or ticagrelor vs clopidogrel). Of the 4,614 randomized participants, 219 (4.7%) had at least 1 ischemic event, among whom 75 (34.2%) had multiple ischemic events. At least 1 hospitalization occurred in 1,125 (24.4%) patients; among them, 384 (34.1%) had multiple hospitalizations. Apixaban, compared with VKA, significantly reduced the risk of total bleeding (rate ratio [RR]: 0.66; 95% CI: 0.55-0.80). Apixaban had similar rates of total ischemic events (RR: 0.83; 95% CI: 0.58-1.20) and total hospitalizations (RR: 0.90; 95% CI: 0.79-1.03) compared with VKA. Aspirin, compared with placebo, significantly increased the risk of total bleeding (RR: 2.14; 95% CI: 1.75-2.60). The rates of total ischemic events (RR: 0.75; 95% CI: 0.52-1.08) and total hospitalizations (RR: 1.11; 95% CI: 0.97-1.27) with aspirin and placebo were similar. CONCLUSIONS Among patients with AF and recent ACS or PCI, apixaban significantly reduced total bleeding risk compared with VKA. Aspirin doubled total bleeding risk compared with placebo without a significant change in total ischemic events. Based on this assessment of total events, our findings support the use of apixaban plus a low-potency P2Y12 inhibitor (ie, clopidogrel) without aspirin as the standard therapy for this high-risk patient population. (A Study of Apixaban in Patients With Atrial Fibrillation, Not Caused by a Heart Valve Problem, Who Are at Risk for Thrombosis [Blood Clots] Due to Having Had a Recent Coronary Event, Such as a Heart Attack or a Procedure to Open the Vessels of the Heart; NCT02415400).
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Tannu et al. (2025) conducted an RCT in Atrial fibrillation and recent acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) (n=4,614). Apixaban vs. Vitamin K antagonist (VKA) was evaluated on Total major or clinically relevant nonmajor bleeding events (RR 0.66, 95% CI 0.55-0.80).
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