Physicians' Academy for Cardiovascular Education

Improved outcomes with DOAC in AF and ACS and/or PCI independent of bleeding and stroke risk

Antithrombotic Therapy in Patients With Atrial Fibrillation After Acute Coronary Syndromes or Percutaneous Intervention

Literature - Harskamp RE, Fanaroff AC, Lopes RD et al., - J Am Coll Cardiol 2022;79:417–427,

Introduction and methods


Patients with AF and who have an acute coronary syndrome (ACS) and/or undergo percutaneous coronary intervention (PCI) have an indication for both anticoagulation and dual antiplatelet therapy (DAPT) [1,2]. Triple antithrombotic therapy, however, is associated with a very high risk of bleeding complications [3].

The AUGUSTUS trial demonstrated that double antithrombotic therapy with a P2Y12 inhibitor in combination with a DOAC reduced ischemic outcomes while avoiding major bleeding in many of these patients [4]. However, there may be subgroups that benefit from more potent antithrombotic regimen [2].

Study design

The AUGUSTUS trial was a multicenter, 2-by-2 factorial, RCT comparing apixaban with VKA and aspirin with placebo. Eligible patients had AF requiring OAC therapy and were hospitalized for ACS and/or underwent PCI with planned use of a P2Y12 inhibitor.

A non-prespecified post hoc analysis of the AUGUSTUS trial was performed to assess safety and efficacy of antithrombotic regimens according to the bleeding score HAS-BLED [5] and the stroke score CHA2DS-VASc [6] in 4386 patients with AF and ACS and/or PCI.

HAS-BLED and CHA2DS-VASc score ≤2 was defined as low risk and scores ≥3 was defined as high risk.

Main outcomes

Safety outcomes were occurrence of major bleeding and major or clinically relevant nonmajor (CRNM) bleeding defined by the ISTH through 6 months of follow-up. Efficacy outcomes included stroke; a composite of death or ischemic events including stroke, MI, probable or definite stent thrombosis, or urgent revascularization; and death or any hospitalization.

Main results

Bleeding outcomes

Efficacy outcomes


In this post hoc analysis of the AUGUSTUS trial changes in bleeding outcomes, rates of death or hospitalization and ischemic events in those randomized to apixaban vs. VKA were independent of baseline bleeding or stroke risk.

The authors conclude that the treatment regimen in the AUGUSTUS trial consisting of apixaban and a P2Y12 inhibitor without aspirin is preferred across a wide range of bleeding and stroke scores in patients with AF and ACS and/or PCI.


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Find this article online at J Am Coll Cardiol

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