Dr Roland Chen Discusses the Primary Endpoints of the GUARD-AF Trial for Atrial Fibrillation

January 31, 2020

The GUARD-AF trial will allow us to look at both the benefits and the risks of screening for atrial fibrillation and the reduction of stroke, said Roland Chen, MD, MS, vice president and head of clinical development for innovative medicines at Bristol-Myers Squibb.

The GUARD-AF trial will allow us to look at both the benefits and the risks of screening for atrial fibrillation and the reduction of stroke, said Roland Chen, MD, MS, vice president and head of clinical development for innovative medicines at Bristol-Myers Squibb.

Transcript

What are some of the primary endpoints being sought by the GUARD-AF trial? How are healthcare claims being utilized to distinguish evidence on health outcomes associated with atrial fibrillation?

The primary efficacy endpoint in GUARD-AF is actually stroke that leads to a hospital evaluation. The primary safety endpoint in GUARD-AF is bleeding that leads to hospitalization. So, GUARD-AF will actually allow us to look at both the benefits and the risks of screening for atrial fibrillation and the reduction of stroke. Healthcare claims are important in this study, because healthcare claims will actually be used to identify the occurrence of these primary endpoints because these patients are receiving Medicare as their health insurance. So this study, although it's a clinical study where patients are randomized, is actually being conducted in a real world setting. So, healthcare claims will be an important part of this pragmatic trial.