Is Eliquis (apixaban) recommended after valve replacement?

Eliquis (Apixaban) After Valve Replacement

Eliquis (apixaban) is not recommended for patients with mechanical heart valves but may be considered for patients with bioprosthetic valves who have atrial fibrillation or other indications for anticoagulation. 1, 2

Mechanical Heart Valves

Contraindication for DOACs

• Apixaban (Eliquis) is explicitly contraindicated for patients with mechanical heart valves 2
• The FDA label for apixaban 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
• This contraindication is based on clinical evidence showing inferior outcomes with DOACs compared to warfarin:
  • The 2023 PROACT Xa trial showed apixaban was less effective than warfarin for preventing valve thrombosis and thromboembolism in patients with On-X mechanical aortic valves 3
  • Earlier, the RE-ALIGN trial with dabigatran was stopped prematurely due to excess thromboembolic and bleeding events in the dabigatran arm 1

Standard of Care for Mechanical Valves

• Vitamin K antagonists (warfarin) remain the only recommended oral anticoagulants for mechanical heart valves 1
• Target INR ranges:
  • Aortic position mechanical valves (bileaflet/Medtronic Hall): INR 2.0-3.0 1, 4
  • Mitral position mechanical valves: INR 2.5-3.5 1, 4
  • Mechanical valves with additional risk factors: INR 2.5-3.5 1, 4
• Addition of low-dose aspirin (75-100 mg daily) to warfarin is reasonable for patients with mechanical valves when bleeding risk is low 1

Bioprosthetic Heart Valves

Early Post-Implantation Period (First 3 Months)

• For bioprosthetic valves, warfarin (INR 2.0-3.0) is reasonable for the first 3 months after implantation 1
• After this initial period, most patients can transition to antiplatelet therapy alone 1

Bioprosthetic Valves with Atrial Fibrillation

• Limited evidence suggests apixaban may be considered for patients with bioprosthetic valves who have atrial fibrillation 1
• The ARISTOTLE (apixaban) and ENGAGE AF-TIMI 48 (edoxaban) trials included small numbers of patients with bioprosthetic valves:
  • Apixaban (41 patients) appeared to be an equitable alternative to warfarin in patients with AF and remote bioprosthetic valve implantation 1
• A 2021 retrospective study found apixaban was safe and well-tolerated in patients requiring anticoagulation following bioprosthetic valve replacement 5

Transcatheter Aortic Valve Replacement (TAVR)

• Antiplatelet therapy is the standard antithrombotic regimen after TAVR 1
• For patients with TAVR who have atrial fibrillation, limited evidence suggests DOACs may be considered 6
• However, low-dose rivaroxaban (10 mg daily) plus aspirin is contraindicated after bioprosthetic TAVR 1

Clinical Decision Algorithm

1. Identify valve type:

   • Mechanical valve → Warfarin only (NOT Eliquis)
   • Bioprosthetic valve → Continue to next step

2. For bioprosthetic valves, consider timing since implantation:

   • First 3 months → Warfarin (INR 2.0-3.0) is preferred
   • After 3 months → Antiplatelet therapy is standard unless other indications for anticoagulation exist

3. For bioprosthetic valves, assess for additional indications for anticoagulation:

   • Atrial fibrillation → Apixaban may be considered
   • No additional indications → Antiplatelet therapy (aspirin 75-100 mg daily)

Important Caveats

• The evidence for using apixaban in patients with bioprosthetic valves is limited, particularly for mitral valve replacements 5
• Ongoing trials are investigating the role of DOACs in preventing bioprosthetic valve thrombosis 7
• Regular monitoring of valve function is essential regardless of anticoagulation strategy
• When transitioning between anticoagulants, ensure appropriate overlap to prevent gaps in anticoagulation