Bristol-Myers Squibb and Pfizer announce randomized, controlled trial to evaluate the effect of atrial fibrillation screening on health outcomes in older individuals

Bristol-Myers SquibbThe Bristol-Myers Squibb-Pfizer Alliance today announced the initiation of a new randomized, controlled study, GUARD-AF (ReducinG stroke by screening for UndiAgnosed atRial fibrillation in elderly inDividuals). The study seeks to determine if earlier detection of atrial fibrillation (AFib) through screening in previously undiagnosed men and women at least 70 years of age in the U.S. ultimately impacts the rate of stroke, compared to usual standard medical care. This study will also assess potential bleeding leading to hospitalization, and therefore provide an evaluation of net clinical benefit or harm. AFib is the most common type of significant irregular heart rhythm, and it is estimated that 8 million people in the U.S. will be affected by AFib in 2019.(1,2) AFib is a significant risk factor for stroke; stroke risk is up to five times higher in people with AFib than in those without it.(3,4) AFib can often go undetected, as it can be asymptomatic,i and some studies suggest that more than 25 percent of people who have an AFib-related stroke find out they have AFib after a stroke.(5)

"There is a real need for a study like GUARD-AF to assess the impact of screening for AFib on the crucially important outcome of stroke," said Daniel Singer, M.D., Professor of Medicine at Harvard Medical School and Professor in the Department of Epidemiology at Harvard T.H. Chan School of Public Health, and an academic general internist at Massachusetts General Hospital. "This study has the potential to directly affect clinical practice and could lead to more AFib patients being identified and appropriately managed to avoid stroke."

AFib-related strokes may have more serious consequences than strokes not related to AFib, and approximately 25 percent of people may die within one month of an AFib-related stroke.(6) Despite this and the increased risk of stroke associated with undiagnosed and untreated AFib, there have been no studies to date demonstrating that proactive screening for AFib in appropriate patient populations reduces stroke risk compared to usual standard medical care, which is defined as normal follow-up care without a proactive screening intervention. This lack of data has been identified as a key gap in knowledge by national screening committees and guideline-making bodies.(7)

"The GUARD-AF trial is important because it seeks to answer vital outcomes questions, and because it intends to do that by including more than 50,000 adults aged 70 and over - a demographic that's at risk and has historically been underrepresented in trials," said Rod MacKenzie, Ph.D., Chief Development Officer and Executive Vice President, Pfizer. "This novel, large-scale, pragmatic study is part of the ongoing commitment by the BMS-Pfizer Alliance to help patients and their care providers find better ways to manage the significant risks that come with atrial fibrillation."

The study population (n=52,000) will include men and women at least 70 years of age visiting their primary care physician for usual follow-up care, who are willing to provide consent to participate in the study. Participants will be randomized to receive the AFib detection intervention using an electrocardiogram (ECG) patch for 14 days, or to receive usual standard medical care. The primary outcome measures will be stroke and bleeding events leading to hospitalization. A novel, pragmatic aspect of the trial is that outcome events will be ascertained from a healthcare claims database which, although subject to certain limitations, are expected to provide evidence on health outcomes associated with AFib detection intervention that may help inform future guidelines.

"Through earlier AFib detection, we're focused on helping to reduce the number of individuals who suffer an AFib-related stroke," said Roland Chen, M.D., Vice President, Head of Clinical Development, Innovative Medicines, Bristol-Myers Squibb. "With this study, the BMS-Pfizer Alliance intends to help inform clinical practice regarding screening for this common type of heart rhythm condition."

Enrollment is expected to begin in the coming weeks. More information on the study can be found on www.clinicaltrials.gov under the identifier NCT04126486.

About the Bristol-Myers Squibb and Pfizer Alliance

The Bristol-Myers Squibb and Pfizer Alliance is committed to driving education and awareness about atrial fibrillation and venous thromboembolism. With long-standing cardiovascular leadership, global scale and expertise in this field, the Alliance strives to implement global, research-driven approaches to illuminate and address the unmet needs around strokes related to non-valvular atrial fibrillation, which are often fatal or debilitating. Through collaborations with non-profit organizations, the Alliance aims to provide patients, physicians, and decision makers with the information they need to understand and take appropriate action on risk factors associated with stroke and other cardiovascular conditions.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

About Pfizer Inc.: Breakthroughs that change patients' lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us.

1. CDC. Atrial Fibrillation Fact Sheet. https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_atrial_fibrillation.htm. Accessed March 2019.
2. Colilla S, Crow A, Petkun W, et al. Estimates of Current and Future Incidence and Prevalence of Atrial Fibrillation in the U.S. Adult Population. Am J Cardiol. 2013;112:1142-1147
3. Cleveland Clinic. Know Your Risk Factors for Stroke. https://my.clevelandclinic.org/health/articles/13398-know-your-risk-factors-for-stroke. Accessed August 28, 2019
4. January CT, Wann LS, Alpert JS, et al. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014;64:e1-76
5. Freedman B, Potpara TS, Lip GY. Stroke prevention in atrial fibrillation. Lancet. 2016;388:806-817
6. Lin HJ, Wolf PA, Kelly-Hayes M, Beiser AS. Stroke severity in AF: Framingham Heart Study. Stroke. 1996; 10:1760-4
7. US Preventive Services Task Force. Screening for Atrial Fibrillation With Electrocardiography: US Preventive Services Task Force Recommendation Statement. JAMA. 2018;320(5):478-484. doi:10.1001/jama.2018.10321

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