Is Eliquis (apixaban) suitable for patients with bioprosthetic valves?

Eliquis (Apixaban) Is Not Recommended for Patients with Bioprosthetic Valves

For patients with bioprosthetic valves, aspirin 75-100 mg daily is recommended as the primary antithrombotic therapy in the absence of other indications for oral anticoagulation, while Eliquis (apixaban) is not specifically approved for this indication. 1

Current Guideline Recommendations for Bioprosthetic Valves

Standard Antithrombotic Therapy

• For patients with bioprosthetic surgical aortic valve replacement (SAVR) or mitral valve replacement, aspirin 75-100 mg daily is reasonable as the primary antithrombotic therapy 1
• For patients with transcatheter aortic valve implantation (TAVI), aspirin 75-100 mg daily is also reasonable 1

Short-Term Anticoagulation After Valve Implantation

• For patients with bioprosthetic SAVR or mitral valve replacement who are at low bleeding risk, vitamin K antagonist (VKA) therapy with an INR target of 2.5 for 3-6 months after surgery may be reasonable 1
• For bioprosthetic TAVI patients at low bleeding risk, VKA with an INR target of 2.5 may be reasonable for at least 3 months after valve implantation 1

Contraindications and Warnings

The FDA label for apixaban specifically states:

• "The safety and efficacy of apixaban tablets have not been studied in patients with prosthetic heart valves. Therefore, use of apixaban tablets is not recommended in these patients." 2

While the FDA label doesn't distinguish between mechanical and bioprosthetic valves, the guidelines are clear that:

• Direct oral anticoagulants (DOACs) including apixaban are contraindicated in patients with mechanical valves 1
• The evidence for DOACs in patients with bioprosthetic valves is limited 3

Special Considerations

Patients with Atrial Fibrillation and Bioprosthetic Valves

There is emerging evidence suggesting that DOACs like apixaban may be considered in patients with atrial fibrillation and bioprosthetic valves 3, but this remains an evolving area with limited robust evidence.

Potential Risks

• A case report has documented bioprosthetic aortic valve thrombosis in a patient receiving effective DOAC therapy 4, highlighting that even with anticoagulation, valve thrombosis can occur
• Small retrospective studies have shown comparable safety and efficacy between DOACs and warfarin in patients with bioprosthetic valves 5, 6, 7, but these studies are limited by their design and sample size

Practical Approach

1. For patients with isolated bioprosthetic valves without other indications for anticoagulation:

   • Use aspirin 75-100 mg daily as the primary antithrombotic therapy 1
   • Consider short-term VKA therapy (3-6 months) after valve implantation if bleeding risk is low 1

2. For patients with bioprosthetic valves who require anticoagulation for other reasons (e.g., atrial fibrillation):

   • VKA therapy remains the better-studied option
   • If a DOAC is being considered, recognize this is an off-label use with limited evidence

Common Pitfalls to Avoid

• Assuming all prosthetic valves can be treated the same way - mechanical valves absolutely require VKA therapy
• Failing to recognize that the early post-implantation period (first 3-6 months) may require different antithrombotic management than long-term therapy
• Overlooking other indications for anticoagulation that might influence the choice of therapy

In conclusion, while emerging evidence suggests potential roles for DOACs in patients with bioprosthetic valves, current guidelines and the FDA label do not specifically recommend Eliquis for patients with bioprosthetic valves. Aspirin remains the standard antithrombotic therapy, with VKA as an option for short-term use after valve implantation.