Pharmacological Therapy

This section explores guideline recommendations and the current evidence for the use of the NOACs in VAF

In this section:

• Defining VAF
• Current guideline recommendations for VAF
• Evidence for the use of NOACs in VAF

Defining VAF

• Oral anticoagulant therapy with VKAs (such as warfarin) has been standard therapy for the prevention of thromboembolism in patients with AF for many years and is recommended by guidelines
• Establishing the origin of AF – VAF or NVAF – is often challenging for physicians, and definitions differ in current guidelines on AF

Current definitions of NVAF and VAF are summarized below.

NVAF was interpreted differently in the designs of the pivotal phase III trials for the NOACs for stroke prevention in patients with AF, with inclusion and exclusion criteria varying with regard to associated VHD as opposed to VAF. As a result, it is considered that although a small number of patients with VHD were included in the phase III studies of the NOACs, their overall profile in patient with VAF remains untested.

Current guideline recommendations in VAF

Of all types of VHD, rheumatic mitral valve disease carries the greatest risk of systemic thromboembolism, and onset of AF further increases this risk; it is the only type of VHD with recommendations for thromboembolic prophylaxis with an anticoagulant (VKA with target INR 2.5, range 2.0–3.0 in patients with AF and mitral stenosis). These ‘high-risk’ patients were excluded from the pivotal phase III trials assessing NOACs in patients with AF.

Data regarding associated stroke risk in patients with mitral valve prolapse, mitral valve regurgitation or aortic valve regurgitation are conflicting or limited; there are currently no specific recommendations for thromboembolic prophylaxis in these patient groups. These patients were not specifically excluded from the pivotal phase III trials of the NOACs in patients with AF, and retrospective analyses assessing outcomes from patients with VHD are available (further information on these subanalyses is provided in the following section).

Evidence for the use of NOACs in VAF

The large phase III studies of the NOACs excluded patients with VAF accompanying mitral stenosis or patients with mechanical prosthetic valves, but did not necessarily exclude those with other types of VHD, such as mitral regurgitation or aortic disease. Retrospective analyses of outcomes in patients with VHD and AF involved in these trials (subanalyses) are summarized below. In general, the benefits of all four NOACs (dabigatran, apixaban, edoxaban and rivaroxaban) for stroke prevention were consistent compared with warfarin in patients with and without VHD.

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Approval No.: PP-XAR-ALL-0392-1