Duke Clinical Research Institute to Begin Nationwide Outcomes Study of Atrial Fibrillation Treatment
10,000-Patient Registry Study to Classify Common Treatment Patterns
To address the need for more information to help improve the care of patients with atrial fibrillation, the Duke Clinical Research Institute (DCRI) is launching the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF).
ORBIT-AF is a prospective, longitudinal, observational study, scheduled to begin in December, which will evaluate treatment patterns and the subsequent outcomes of 10,000 patients in the United States.
The registry will enable a contemporary, real-world description of atrial fibrillation and its consequences. Information from more than 300 hospitals and clinics in the U.S. will be collected and analyzed, including patient demographics, risk profiles, geographic considerations, insurance and provider information, and other clinical factors.
Specifically, the ORBIT-AF registry will describe how atrial fibrillation affects health outcomes, costs, and quality of life, while offering insight on how the impact of atrial fibrillation can be minimized through more effective use of existing and emerging treatments.
“Atrial fibrillation has a significant effect on the American health care system, as it increases a patient’s risk for suffering a stroke by up to five times,” said cardiologist Eric Peterson, MD, MPH, Associate Director, DCRI, and Chairman of the ORBIT-AF registry.
“Today, very few data are available on how physicians actually treat patients with atrial fibrillation. We expect ORBIT-AF will provide valuable insights that could potentially improve patient care and outcomes for patients with atrial fibrillation.”
Atrial fibrillation is the most common sustained arrhythmia (abnormal heart rhythm) in the United States and affects more than two million Americans; this number is expected to increase to nearly 16 million by 2050.
AF puts patients at serious risk for stroke; each year, about 800,000 people in the U.S. have a stroke, and AF accounts for 15-20 percent of these cases. Over the last 20 years, hospital admissions for AF have increased by 60 percent, and the estimated annual cost of care for a patient with AF is $15,553.
Consistent with its increasing burden to the public health, atrial fibrillation was recently named the top priority for comparative effectiveness research by the Institute of Medicine.
The ORBIT-AF study will also take a close look at the use of antithrombotic agents, sometimes referred to as blood-thinners, regularly used to help prevent strokes in patients with atrial fibrillation. This assessment will specifically evaluate how patients comply with their treatments and the subsequent impact of those decisions on their health.
“Atrial fibrillation is a growing, pervasive epidemic and a leading cause of stroke-related death and disability in this country. The good news is that over the past 10 years, there has been an explosion in the number of clinical trials focused on improving health care in patients with atrial fibrillation,” explains Jonathan Piccini, MD, MHS, Co-Chair of the ORBIT-AF Coordinating Center at DCRI.
“Despite the availability of highly effective therapies, the bad news is that stroke prevention measures for patients with atrial fibrillation are underutilized. On average, only half of eligible patients receive anticoagulation. Therefore, the treatment of atrial fibrillation remains a great opportunity to improve the quality of cardiovascular care in the US.”
The ORBIT-AF (Outcomes Registry for Better Informed Treatment of Atrial Fibrillation) registry is a 10,000 patient, prospective observational outpatient registry planned to identify and analyze clinical treatment patterns of atrial fibrillation across the U.S. ORBIT-AF will also generate valuable insights that could potentially reduce risk and improve outcomes for patients with this condition.
All adult patients with atrial fibrillation are eligible for enrollment in ORBIT-AF. Enrollment is expected to take up to two years, and those patients will be followed prospectively on an outpatient basis with compliance and outcomes data collected at six, 12, 18, and 24 months after enrollment.
Data captured will include demographics, cardiovascular risk factors, diagnosis, antithrombotic therapy and therapeutic blood monitoring, types of concomitant medications and doses, insurance and provider information, patient quality-of-life reports, and anticoagulation treatment satisfaction and compliance.
Assessments will also measure rates of heart attacks, stroke, hospitalization, and other major adverse cardiovascular events, among treated and under-treated patients.
Leading researchers and clinicians joining Dr. Peterson on the steering committee for this trial are: Jack E. Ansell, MD, Chairman of Medicine, at Lenox Hill Hospital, New York City; Gregg C. Fonarow, MD, Director, Ahmanson-UCLA Cardiomyopathy Center, Los Angeles; Bernard J. Gersh, MD, Professor of Medicine, Mayo Clinic, Minnesota; Alan S. Go, MD, Assistant Director for Clinical Research, Kaiser Permanente, Northern California; Elaine Hylek, MD, MPH, Boston University School of Medicine, Boston; Peter Kowey, MD, Chief of the Division of Cardiovascular Diseases at the Lankenau Hospital and the Main Line Health System, Wynnewood, PA; Kenneth W. Mahaffey, MD, Associate Professor of Medicine, Duke University, Durham, North Carolina; and Roger Mills, MD, Senior Director for Cardiology, Medical Affairs, Ortho-McNeil-Janssen, Inc.
ORBIT-AF is being co-developed by Duke Clinical Research Institute and Ortho-McNeil-Janssen Scientific Affairs, LLC, which has also provided funding for the study.