Is Eliquis (apixaban) indicated for atrial fibrillation (AFib) in a patient with recent healing of a duodenal ulcer perforation?

From the Guidelines

Eliquis (apixaban) should be avoided in patients with atrial fibrillation who have a recently healed duodenal ulcer perforation due to the increased bleeding risk, as recommended by the 2024 ESC guidelines for the management of atrial fibrillation 1. Instead, consider alternative stroke prevention strategies initially. Once the ulcer has completely healed and the patient is stable (typically 4-6 weeks post-healing with confirmation via endoscopy), Eliquis may be cautiously reintroduced with close monitoring. During this waiting period, a heparin bridge or low-dose aspirin might be used depending on the patient's stroke risk, as suggested by the 2019 AHA/ACC/HRS focused update of the 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation 1. When restarting Eliquis, standard dosing is typically 5mg twice daily, though 2.5mg twice daily may be appropriate for patients with additional bleeding risk factors, as indicated by the antithrombotic therapy for atrial fibrillation: CHEST guideline and expert panel report 1. Concurrent proton pump inhibitor therapy (such as pantoprazole 40mg daily) is strongly recommended to reduce gastrointestinal bleeding risk. The patient should be monitored for any signs of recurrent bleeding, including black stools, abdominal pain, or dizziness, and should undergo regular follow-up endoscopies as determined by their gastroenterologist. Key considerations include:

• Assessing the risk of thromboembolism using locally validated risk tools or the CHA2DS2-VA score, as recommended by the 2024 ESC guidelines 1
• Managing modifiable bleeding risk factors to improve safety, as suggested by the 2019 AHA/ACC/HRS focused update 1
• Avoiding the combination of anticoagulants and antiplatelet agents, unless necessary, as indicated by the antithrombotic therapy for atrial fibrillation: CHEST guideline and expert panel report 1

From the FDA Drug Label

1 INDICATIONS & USAGE

1.1 Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation Apixaban tablets are indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

The FDA drug label indicates that Eliquis (apixaban) is used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AFib). However, it does not provide information about its use in patients with a recent healing of a duodenal ulcer perforation.

• The label does not address the safety of apixaban in patients with recent gastrointestinal perforation.
• Therefore, based on the available information, no conclusion can be drawn about the use of Eliquis in a patient with recent healing of a duodenal ulcer perforation 2.

From the Research

Indication of Eliquis (Apixaban) for Atrial Fibrillation (AFib) in Patients with Recent Healing of a Duodenal Ulcer Perforation

• The use of apixaban in patients with atrial fibrillation and a history of gastrointestinal bleeding, including duodenal ulcer perforation, has been evaluated in several studies 3, 4, 5, 6.
• A study published in 2021 found that direct oral anticoagulants (DOACs), including apixaban, were associated with a lower risk of upper gastrointestinal bleeding compared to warfarin in patients with atrial fibrillation and a history of peptic ulcer disease 5.
• Another study published in 2020 found that patients with a history of gastrointestinal bleeding, including those with a recent history of bleeding, had a higher risk of major gastrointestinal bleeding when treated with apixaban or warfarin, but the risk of stroke or systemic embolism was not increased 6.
• A study published in 2017 found that dabigatran, another DOAC, was associated with an increased risk of gastrointestinal bleeding compared to warfarin, but the risk of intracranial bleeding was lower with dabigatran 7.
• The ARISTOTLE trial, which compared apixaban to warfarin in patients with atrial fibrillation, found that apixaban was associated with a lower risk of major bleeding, including gastrointestinal bleeding, compared to warfarin 6.

Safety and Efficacy of Apixaban in Patients with AFib and a History of Duodenal Ulcer Perforation

• The safety and efficacy of apixaban in patients with atrial fibrillation and a history of duodenal ulcer perforation have not been specifically evaluated in clinical trials.
• However, the available data suggest that apixaban may be a suitable option for patients with atrial fibrillation and a history of gastrointestinal bleeding, including duodenal ulcer perforation, due to its lower risk of major bleeding compared to warfarin 4, 5, 6.
• Patients with a history of gastrointestinal bleeding, including those with a recent history of bleeding, should be closely monitored for signs of bleeding when treated with apixaban or other anticoagulants 6.