PCORI hosted a multi-stakeholder workshop to discuss whether comparative clinical effectiveness research (CER) can help to answer questions surrounding use of newer oral anticoagulants (blood thinners). We asked representatives of a wide range of stakeholder groups, including patients, caregivers, clinicians, industry, payers, and researchers to participate in this discussion.

Oral anticoagulants are used to prevent stroke in people with atrial fibrillation, to treat deep vein thrombosis (DVT), and in the post-operative setting after hip and knee replacement to prevent DVT. Warfarin has been the most commonly used oral anticoagulant. In recent years, a set of new oral anticoagulants (NOACs, also called direct thrombin inhibitors or factor Xa inhibitors) have become increasingly used due to several potential advantages over warfarin, including easier dosing and lack of need for laboratory monitoring of the prothrombin time. However, the NOACs are much more expensive than warfarin, and there are some concerns about their lack of reversibility in the face of bleeding, although specific antidotes are expected to be marketed soon. Relevant questions about available evidence to be discussed in the workshop include:

1. For each of these clinical conditions, is sufficient evidence and information available to allow patients and clinicians to choose between warfarin and a NOACs and/or among NOACs?
2. Are there subgroups of patients, such as those with renal dysfunction, for whom sufficient information is lacking for optimal decision-making about which agent to use?
3. Are there other specific clinical issues, such as patients on oral anticoagulants who require surgery, for which evidence is lacking to allow optimal decision-making about managing NOACs, including when to stop and restart therapy?

In-person attendance was by invitation only, but the public was welcome to listen in via teleconference/webinar.

Meeting Materials

• Agenda
• Participants' List
• Topic Brief
• Submitted Questions
• Introduction Session - Presentation Slides
• Presentation Slides
• Meeting Summary

Teleconference Audio Recording