What are the recommendations for Eliquis (apixaban) in atrial fibrillation (AFib) versus the risk of intracranial hemorrhage in the elderly?

From the Guidelines

Eliquis (apixaban) is recommended for elderly patients with atrial fibrillation at a standard dose of 5 mg twice daily, with careful consideration of dose reduction to 2.5 mg twice daily for those meeting specific criteria, to balance stroke prevention and bleeding risk. When considering the use of Eliquis in elderly patients with atrial fibrillation, it's essential to weigh the benefits of stroke prevention against the risks of bleeding, particularly intracranial hemorrhage 1. The CHADS2 score, which takes into account factors such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, and prior stroke or transient ischemic attack, can help guide this decision 1.

For patients at high risk of stroke, oral anticoagulation is recommended, and Eliquis has been shown to have a more favorable safety profile regarding brain bleeds compared to warfarin in the elderly 1. Key considerations for the use of Eliquis in this population include:

• Dose reduction to 2.5 mg twice daily for patients meeting two or more of the following criteria: age ≥80 years, weight ≤60 kg, or serum creatinine ≥1.5 mg/dL
• Regular monitoring of renal function to guide potential dose adjustments
• Patient education on bleeding signs and the importance of consistent medication timing
• Avoidance of NSAIDs and other medications that increase bleeding risk

In the context of real-life clinical medicine, a careful and individualized approach to the use of Eliquis in elderly patients with atrial fibrillation is necessary, taking into account the patient's unique risk factors and medical history 1.

From the FDA Drug Label

The recommended dose of apixaban tablets for most patients is 5 mg taken orally twice daily. The recommended dose of apixaban tablets is 2.5 mg twice daily in patients with at least two of the following characteristics:

• age greater than or equal to 80 years
• body weight less than or equal to 60 kg
• serum creatinine greater than or equal to 1.5 mg/dL

In the ARISTOTLE study, the results for major bleeding were generally consistent across most major subgroups including age.

• Intracranial bleed includes intracerebral, intraventricular, subdural, and subarachnoid bleeding.
• Any type of hemorrhagic stroke was adjudicated and counted as an intracranial major bleed.

Key points:

• The dose of apixaban in elderly patients (age ≥ 80 years) with atrial fibrillation is 2.5 mg twice daily if they have at least two of the following characteristics: age ≥ 80 years, body weight ≤ 60 kg, or serum creatinine ≥ 1.5 mg/dL.
• The risk of intracranial bleeding is lower with apixaban compared to warfarin, with a hazard ratio of 0.41 (0.30,0.57) in the ARISTOTLE study 2.
• The risk of hemorrhagic stroke is also lower with apixaban compared to warfarin, with a hazard ratio of 0.51 (0.34,0.75) in the ARISTOTLE study 2.

From the Research

Recommendations for Eliquis in Atrial Fibrillation

The use of anticoagulants such as Eliquis (apixaban) in elderly patients with atrial fibrillation is a complex issue, balancing the risk of stroke against the risk of bleeding, including brain bleed.

• The management of atrial fibrillation in the elderly is directed at preventing thromboembolism and controlling the heart rate and rhythm 3.
• Guidelines recommend systemic anticoagulation for almost all patients age 65 and older, but in practice, up to 50% of older patients do not receive maintenance anticoagulation therapy due to concerns about fall risk and associated bleeding 4.
• The benefits of oral anticoagulants (OACs) generally outweigh the risks in most older patients with atrial fibrillation, and non-vitamin K antagonist OACs (NOACs) such as Eliquis may be more favorable choices compared to warfarin for stroke prevention in the elderly 5, 6.

Risk of Brain Bleed in the Elderly

The risk of brain bleed, including intracranial hemorrhage, is a concern in elderly patients with atrial fibrillation, particularly in those with a history of falls or other bleeding risks.

• The use of anticoagulants such as Eliquis may increase the risk of brain bleed, but the overall benefit of stroke prevention may still outweigh this risk in many patients 5, 6.
• Risk stratification schemes can help guide the anticoagulation decision, taking into account individual patient factors such as fall risk, bleeding history, and other comorbidities 3, 4.

Considerations for Eliquis Use

When considering the use of Eliquis in elderly patients with atrial fibrillation, several factors should be taken into account, including:

• The patient's individual risk of stroke and bleeding, including brain bleed 5, 6.
• The presence of comorbidities, such as kidney disease or liver disease, which may affect the metabolism of Eliquis 6.
• The patient's ability to adhere to the prescribed treatment regimen, including regular monitoring of kidney function and other laboratory tests 6.