Dr Roland Chen Outlines the GUARD-AF Trial as a Preventive Mechanism in Reducing Risk of Stroke

The GUARD-AF trial promotes heightened knowledge of stroke risk among patients with atrial fibrillation by analyzing, evaluating, and distributing important data back to practitioners, which can possibly reduce the incidence of stroke, said Roland Chen, MD, MS, vice president and head of clinical development for innovative medicines at Bristol-Myers Squibb.

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Can you discuss the implementation of the GUARD-AF trial and why a study focusing on preventive measures associated with the likelihood of related adverse outcomes (e.g. stroke) is warranted?

GUARD-AF is a potentially practice informing study that could help change the way in which medicine is practiced in reducing stroke in patients with atrial fibrillation (AF). AF is a condition with a high unmet need. It's estimated that about 8 million people in the United States have atrial fibrillation; but importantly, many people are not aware that they have atrial fibrillation. Many people find that stroke is the first sign of their atrial fibrillation, and strokes in people with AF are severe. In about 25% of individuals, they will die prematurely in the first 30 days after a stroke. However, there haven't been any studies that have demonstrated that screening for AF actually reduces the risk of stroke versus usual care. So, GUARD-AF is a study that will provide important information on that question.

Maybe I could take a few moments to describe the GUARD-AF study. GUARD-AF is a study that compares screening for atrial fibrillation versus standard of care. It'll randomize 52,000 patients over 300 US primary care centers—these will be patients who are on Medicare. Now patients who are randomized to receive screening will administer a patch for 14 days which will collect information on their heart rhythm. This data will be analyzed, evaluated, and fed back to the practitioner. The practitioner can then make an informed judgment on how best to treat that patient moving forward. So, GUARD-AF will hopefully provide important information on whether that intervention, that is screening for stroke or screening for atrial fibrillation, will actually reduce the incidence of stroke.