Eliquis (Apixaban) Should NOT Be Used in Patients with Porcine Aortic Valves
Eliquis (apixaban) is explicitly contraindicated in patients with prosthetic heart valves, including bioprosthetic (porcine) valves, and should not be used. 1 The FDA drug label for apixaban clearly states that "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." 1
Why Direct Oral Anticoagulants Are Contraindicated
DOACs including apixaban are explicitly contraindicated in all patients with prosthetic valves (both mechanical and bioprosthetic) based on increased thrombotic and bleeding complications demonstrated in clinical trials. 2, 3
The RE-ALIGN trial demonstrated increased thromboembolic and bleeding complications with dabigatran (another DOAC) compared to warfarin in patients with mechanical heart valves, leading to early trial termination. 4 This finding has been extrapolated to all DOACs and all prosthetic valves as a class effect.
The American College of Cardiology and American Heart Association explicitly state that DOACs (dabigatran, rivaroxaban, apixaban) are contraindicated in mechanical valve patients, and this caution extends to bioprosthetic valves where safety data are lacking. 3
Correct Anticoagulation Strategy for Porcine Aortic Valves
First 3 Months Post-Implantation
For aortic bioprosthetic valves in patients with normal sinus rhythm, aspirin 50-100 mg daily is the preferred initial therapy. 4, 3
Alternatively, warfarin with target INR 2.0-3.0 may be considered for the first 3 months, though this is more commonly reserved for mitral bioprosthetic valves or patients with additional risk factors. 4
After 3 Months (Long-Term Management)
Aspirin 75-100 mg daily is recommended for all patients with bioprosthetic aortic valves in normal sinus rhythm. 4
The long-term thromboembolic risk with aortic bioprosthetic valves is low (approximately 0.2% per year) in patients with sinus rhythm, making aspirin alone appropriate. 4
One study demonstrated a significantly lower thromboembolic rate (1.3% per patient-year) in patients taking aspirin compared to those not taking aspirin (5.2% per patient-year) after aortic porcine bioprosthesis. 5
Special Circumstances Requiring Warfarin
If any of the following high-risk features are present, warfarin (INR 2.0-3.0) should be used instead of aspirin alone: 4, 3
- Atrial fibrillation
- Previous thromboembolic event
- Left ventricular systolic dysfunction
- Hypercoagulable condition
- Left atrial thrombus on imaging
Critical Pitfalls to Avoid
Never substitute apixaban or any other DOAC for warfarin in patients with any type of prosthetic valve (mechanical or bioprosthetic), as this is associated with increased valve thrombosis and stroke risk. 2, 3, 1
Do not assume that bioprosthetic valves are "non-valvular" for the purposes of DOAC use—the FDA contraindication applies to all prosthetic valves regardless of type. 1
Do not underdose warfarin out of bleeding concerns in patients who require it, as the thrombotic risk is prohibitive without adequate anticoagulation. 3
Evidence Quality Considerations
The guideline recommendations for aspirin after bioprosthetic aortic valve replacement are based on moderate-quality evidence (Grade 2C), reflecting observational data rather than large randomized trials. 4
While animal studies have shown some promise for apixaban in preventing mechanical valve thrombosis 6, 7, these preclinical findings have not translated to human safety or efficacy, and the FDA contraindication remains absolute. 1
A recent randomized trial found no benefit of adding warfarin to aspirin for bioprosthetic aortic valves in terms of hemodynamics or functional outcomes at 1 year, supporting the use of aspirin alone in standard-risk patients. 8