Can Eliquis (apixaban) be used for patients undergoing mitral valve replacement?

Apixaban (Eliquis) Should Not Be Used for Mechanical Mitral Valve Replacement

Apixaban (Eliquis) is contraindicated for patients with mechanical mitral valve replacement and should not be used in this population. 1 Vitamin K antagonists (warfarin) remain the only recommended oral anticoagulants for mechanical heart valves.

Anticoagulation for Different Types of Valve Replacements

Mechanical Mitral Valve Replacement

• Warfarin is the only recommended anticoagulant with a target INR of 2.5-3.5 2
• Addition of low-dose aspirin (75-100 mg daily) to warfarin is reasonable when bleeding risk is low 2
• Direct oral anticoagulants (DOACs) including apixaban are contraindicated:
  • The FDA label specifically states: "The safety and efficacy of apixaban tablets have not been studied in patients with prosthetic heart valves" 1
  • The RE-ALIGN trial with dabigatran (another DOAC) showed increased rates of thromboembolic and bleeding complications in patients with mechanical heart valves 3

Bioprosthetic Mitral Valve Replacement

• For the first 3 months after bioprosthetic mitral valve replacement:
  • Warfarin with a target INR of 2.0-3.0 is recommended 2
• After 3 months:
  • Patients with no additional risk factors can transition to aspirin 75-100 mg daily 2
  • Patients with atrial fibrillation or other indications for anticoagulation may be considered for apixaban 2, 4

Evidence Supporting These Recommendations

The 2021 ACC/AHA guideline for valvular heart disease clearly states that for patients with mechanical mitral valve replacement, anticoagulation with a vitamin K antagonist (warfarin) is indicated to achieve an INR of 3.0 2.

The ARISTOTLE trial included a small subgroup of patients (n=104) with bioprosthetic valves, including 26 with mitral bioprosthetic valves. The results suggested that apixaban may be reasonable for patients with bioprosthetic valves, but the sample size was too small to draw definitive conclusions 4.

A retrospective study of 54 patients with bioprosthetic valve replacements on apixaban showed that it was generally safe, but the authors concluded that "more prospective data are needed to further correlate the safety and efficacy of apixaban, particularly in the setting of mitral valve replacement" 5.

Important Distinctions in Valve Types

The 2019 AHA/ACC/HRS focused update on atrial fibrillation management makes an important distinction:

1. Mechanical valves: Require lifelong vitamin K antagonist therapy (warfarin)
2. Bioprosthetic valves: May be considered for DOAC therapy if the patient has atrial fibrillation after the initial 3-month period of warfarin therapy 2

Pitfalls to Avoid

• Never substitute apixaban for warfarin in patients with mechanical heart valves. This has been associated with increased thromboembolic events, as demonstrated with dabigatran in the RE-ALIGN trial 3
• Don't confuse recommendations for bioprosthetic valves with mechanical valves. The anticoagulation strategies differ significantly
• Be aware that the EHRA classification system distinguishes between:
  • Type 1 VHD (including mechanical valves): Requires VKA therapy
  • Type 2 VHD (including bioprosthetic valves): May be eligible for NOAC therapy 2

In conclusion, apixaban should not be used for patients with mechanical mitral valve replacement. Warfarin with a target INR of 2.5-3.5 remains the standard of care for these patients.