This section discusses the importance of anticoagulation therapy for patients with prosthetic valves and examines the current guideline recommendations, current evidence for, and ongoing studies on, the use of NOACs in these patients
In this section:
- Importance of anticoagulation therapy for patients with prosthetic valves
- Current guideline recommendations for patients with prosthetic valves
- Current evidence with NOACs for patients with prosthetic valves
Importance of anticoagulation therapy for patients with prosthetic valve
Thromboembolism and anticoagulant-related bleeding represent the majority of complications experienced by prosthetic valve recipients. The need for chronic anticoagulation therapy as a result of AF accompanying valvular heart disease highlights the importance of optimizing the quality of anticoagulation care to minimize postoperative thromboembolic complications, while maintaining an acceptable risk profile.
Current guideline recommendations for patients with prosthetic valves
After valve repair with a mechanical or bioprosthetic device, VKA therapy is indicated for the prevention of stroke and systemic embolism; American College of Chest Physicians (ACCP) and American College of Cardiology (ACC)/American Heart Association (AHA)4 guidelines provide recommendations based on the type and position of valve replacement (summarized in Figure) due to the differing associated risk of thromboembolic events:
- Bioprostheses: recommended for patients irrespective of age for whom anticoagulant therapy is contraindicated, cannot be managed, or is not desired
- Mechanical prostheses: for aortic valve replacement or mitral valve replacement in patients
<60 yearsof age without contraindications to anticoagulation
- Mechanical valves in the mitral position: generally more thrombogenic than those in the aortic position
Current evidence with NOACs for patients with prosthetic valves
To date, only one clinical trial – the phase II RE-ALIGN trial – assessed the performance of an NOAC (dabigatran; N=37) versus warfarin (N=22) in patients with a mechanical heart valve. There was an increased rate of thromboembolic and bleeding complications associated with dabigatran versus warfarin that resulted in the trial being terminated prematurely.5
The role of NOACs in patients with prosthetic valves requires further research; two ongoing phase II clinical trials are investigating the efficacy and safety of rivaroxaban for the prevention of major complications in patients undergoing mechanical aortic valve replacement (CATHAR trial; ClinicalTrials.gov NCT02128841) and exploring how rivaroxaban compares with VKA therapy in patients with AF with bioprosthetic mitral valves (RIVER trial; ClinicalTrials.gov NCT02303795).
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