Abbreviated Antithrombotic Therapy After PCI in Patients With AF and AMI

Advancements in device technologies for PCI and adjunct pharmacotherapy have recently shifted research focus toward balancing bleeding risk reduction with the management of ischemic events through novel antithrombotic strategies. These trends are particularly relevant for patients with atrial fibrillation (AF) who require lifelong oral anticoagulation to prevent embolic events. Traditionally, the combination of vitamin K antagonists (such as warfarin) with antiplatelet agents has been regarded as the standard approach to mitigate ischemic risk following PCI in patients with AF. However, previous studies have consistently demonstrated that dual antithrombotic therapy (DAT) utilizing direct oral anticoagulants (DOACs) results in reduced bleeding complications compared to triple antithrombotic therapy based on warfarin.

For long-term maintenance, DOAC monotherapy is recommended, as a Class I, after 6 to 12 months post-PCI for patients with stable coronary artery disease (CAD) and AF. Recent randomized clinical trials corroborate these recommendations. The AFIRE (Atrial Fibrillation and Ischemic Events with Rivaroxaban in Patients with Stable Coronary Artery Disease) study showed that rivaroxaban monotherapy was non-inferior to DAT in terms of both bleeding and ischemic outcomes. The EPIC-CAD (Edoxaban versus Edoxaban with Antiplatelet Agent in Patients with Atrial Fibrillation and Chronic Stable Coronary Artery Disease) trial further extended this evidence, indicating that edoxaban monotherapy reduced the risk of net adverse clinical events (NACE)-a composite of death, myocardial infarction, stroke, systemic embolism, unplanned urgent revascularization, and major or clinically relevant nonmajor bleeding-compared to DAT. Recently, the ADAPT AF-DES (Appropriate Duration of Antiplatelet and Thrombotic Strategy after 12 Months in Patients with Atrial Fibrillation Treated with Drug-Eluting Stents) trial demonstrated that DOAC monotherapy was non-inferior, and even superior, to combination therapy with a DOAC and clopidogrel regarding NACE reduction in patients with AF and stable CAD following PCI. However, these studies have primarily focused on patients with stable CAD who inherently have a lower ischemic risk. Despite limited evidence supporting DOAC monotherapy as a maintenance strategy for acute myocardial infarction (AMI) patients, recent guidelines have also recommended this approach after 1 year (Class I) or 6 months (Class IIB) following PCI in AMI setting. Furthermore, in real-world data, the DAT remained effective in reducing ischemic events without increasing the risk of bleeding compared with DOAC monotherapy. Additionally, DOAC monotherapy showed a lower risk of NACE at 3 years, but was not significantly effective at 1 year after PCI.

To address this critical evidence gap in clinical practice, we have developed the Heart-team for Evidence-based Revascularization: Abbreviated Antithrombotic Therapy After Percutaneous Coronary Intervention in Patients with Atrial Fibrillation and Acute Myocardial Infarction (HERO-AF-AMI). This study aims to evaluate the impact of DOAC monotherapy compared to DAT (DOAC plus clopidogrel) in patients with AF and AMI undergoing PCI.

• Rate of major bleeding by ISTH [Time frame: 1 year after the last patient enrollment]
• Rate of MACCE (major adverse cardiac and cerebrovascular event) [Time frame: 1 year after the last patient enrollment]
• All-cause death [Time frame: 1 year after the last patient enrollment]
• Cardiovascular death [Time frame: 1 year after the last patient enrollment]
• Rate of non-fatal MI [Time frame: 1 year after the last patient enrollment]
• Rate of ischemic stroke [Time frame: 1 year after the last patient enrollment]
• Rate of systemic embolization [Time frame: 1 year after the last patient enrollment]
• Rate of unplanned revascularization [Time frame: 1 year after the last patient enrollment]
• Rate of definite stent thrombosis [Time frame: 1 year after the last patient enrollment]
• Rate of cardiovascular death or non-fatal MI [Time frame: 1 year after the last patient enrollment]
• Rate of all-cause death, non-fatal MI, stroke, systemic embolization, stent thrombosis, or ISTH major bleeding [Time frame: 1 year after the last patient enrollment]
• Rate of major or clinically relevant non-major bleeding by ISTH [Time frame: 1 year after the last patient enrollment]