Goal 2: Reduce Human Disease

Need to assess a new method of warfarin management vs. new oral anticoagulants in patients with atrial fibrillation

The two obstacles to warfarin therapy (keeping the INR in range and the associated hassles of frequent lab visits) can be eliminated by INR self testing and online "virtual clinic" monitoring and management (as demonstrated in six small studies. Achieving an INR percent time in range of approximately 75% to 80% is associated with a 50% or lower rate of thromboembolism and major bleeding. The studies of new oral anticoagulants were conducted largely outside of the U.S. in a large number of countries where warfarin management was sub-optimal. Reasonable projections are that warfarin managed with INR self testing and one of the available online virtual clinic systems would be superior to the new agent in terms of safety and efficacy in AF.

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Critical Challenge (CC)

Details on the impact of addressing this CQ or CC

If the ease and convenience of INR self testing, when combined with online virtual clinic management, can double the safety and efficacy of warfarin therapy, this form of therapy will benefit millions of patients with atrial fibrillation world wide. By extrapolation, this mode of therapy may also benefit millions of patients at risk of venous thrombosis, myocardial infarction, and stroke.

Feasibility and challenges of addressing this CQ or CC

This issue would require a prospective randomized control trial in moderate to high risk patients with atrial fibrillation to compare warfarin managed with such a system vs treatment with one of the new oral anticoagulants. Additional issues could be addressed if the study also included a warfarin arm with traditional management and/or an arm that involved monitoring of the new agent. The projected impact of the new warfarin management method on a composite end point of stroke, systemic embolism, major bleed and death is large enough (30 to 60 fewer events per 1,000 patients per year) that the sample size would be much smaller than the trials used to evaluate the new agents vs warfarin in atrial fibrillation.

Name of idea submitter and other team members who worked on this idea Henry I. Bussey, Pharm.D.

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Idea No. 562