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CLINICAL STATEMENTS AND GUIDELINES

Circulation. 2024;149:e1–e156. DOI: 10.1161/CIR.0000000000001193 January 2, 2024 e53

Joglar et al 2023 Guideline for the Diagnosis and Management of Atrial Fibrillation

with a lower risk of clinically relevant bleeding compared to VKAs.1–5 They have also shown that dual therapy with an OAC and single APT with a P2Y12 inhibitor significantly lowers the risk of clinically relevant bleeding compared with triple therapy (oral anticoagulation, P2Y12 inhibitor, and aspirin) without substantially increasing risk of major adverse cardiovascular events.1–4,6 Metaanalyses of these trials have shown a slightly increased risk of stent thrombosis with dual therapy compared to triple therapy.5 Thus, the risk of stent thrombosis must be weighed against the risk of bleeding in determining the antithrombotic regimen after PCI. This is particularly true in patients with a relatively high perceived risk of stent thrombosis (complex revascularization, multivessel PCI, previous history of stent thrombosis). Recommendation-Specific Supportive Text 1.	 Post-PCI antithrombotic regimens comparing

DOACs with VKAs in combination with APT in patients with AF who do not have a specific indication for VKAs (eg, mechanical valve) have consistently shown a reduction in clinically relevant bleeding.1,2,4 A meta-analysis of 3 RCTs comparing DOACs with VKAs after PCI, PIONEER AF-PCI (Open-Label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects with Atrial Fibrillation who Undergo Percutaneous Coronary Intervention) (rivaroxaban), RE-DUAL PCI trial (Randomized Evaluation of Dual Antithrombotic Therapy with Dabigatran versus Triple Therapy with Warfarin in Patients with Nonvalvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention) (dabigatran), and AUGUSTUS (Open-Label, 2×2 Factorial, Randomized, Controlled Clinical Trial to Evaluate the Safety of Apixaban vs Vitamin K Antagonist and Aspirin vs Aspirin Placebo in Patients With Atrial Fibrillation and Acute Coronary Syndrome and/or Percutaneous Coronary Intervention) (apixaban), showed a 42% relative risk reduction for major bleeding in DOAC-based regimens compared with VKA-based regimens (OR, 0.577 [95% CI, 0.477-0.698]; P<0.001).5 There was no statistically significant difference in the risk of ischemic events between groups. The ENTRUST-AF PCI (Edoxaban Treatment vs Vitamin K Antagonist in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention) trial showed that edoxaban-based regimens were noninferior to VKA-based regimens in terms of clinically relevant bleeding after PCI.3 An important limitation of the aforementioned data is that most studies compared DOACs monotherapy against VKA plus aspirin, the only VKA-based dual antithrombotic therapy (DAT) regimen was available in AUGUSTUS trial, thus providing limited information in comparison to DOAC-based DAT regimens available in all trials.5

2.	 RCTs have supported DAT with OAC and a P2Y12

inhibitor over triple therapy with OAC, P2Y12 inhibitor, and aspirin to reduce the risk of clinically relevant bleeding in patients with AF after PCI, including WOEST (What Is the Optimal Antiplatelet and Anticoagulant Therapy in Patients with Oral Anticoagulation and Coronary Stenting) (VKA), PIONEER AF-PCI (rivaroxaban), RE-DUAL (dabigatran), and AUGUSTUS (apixaban).1,2,4,6 A metaanalysis of PIONEER AF-PCI, RE-DUAL, and AUGUSTUS demonstrated a 40% relative risk reduction for International Society on Thrombosis and Haemostasis major bleeding in dual therapy regimens compared with triple therapy (OR, 0.598 [95% CI, 0.491-0.727]; P<0.001).5 Patients in the intervention group received varying duration of triple therapy with aspirin after PCI up to 7 days. This meta-analysis showed that DAT with DOAC and P2Y12 inhibitor was associated with an increased risk of stent thrombosis (OR, 1.672 [95% CI, 1.022-2.733]; P=0.041) compared with triple therapy.5 This finding was mainly driven by outcomes in the 110-mg dosing group of dabigatran in the RE-DUAL trial. The number needed to treat for International Society on Thrombosis and Haemostasis major bleeding (n=42) was substantially lower than the number needed to harm for stent thrombosis (n=223) with DAT compared with triple therapy.5 Based on these findings, extended triple therapy up to 30 days after PCI is a consideration when the perceived risk of stent thrombosis is high (eg, complex revascularization, multivessel PCI, previous history of stent thrombosis).

6.8.2 Chronic Coronary Disease (CCD)

Recommendation for CCD Referenced studies that support the recommendation are summarized in the Online Data Supplement. COR LOE Recommendation

1 B-R 1 In patients with AF and CCD (beyond 1 year after

revascularization or CAD not requiring coronary revascularization) without history of stent thrombosis, oral anticoagulation monotherapy is recommended over the combination therapy of OAC and single APT (aspirin or P2Y12 inhibitor) to decrease the risk of major bleeding.1–3

Synopsis APT is the first-line therapy to prevent recurrent cardiovascular events in patients with CAD, while anticoagulation therapy is recommended to prevent stroke or systemic embolism in patients with AF at increased risk of thromboembolism. Minimal evidence was available until recently if a combination therapy of APT in addition to OAC therapy provides additional value to prevent cardiovascular

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