Boehringer Ingelheim announced on 31 March, 2009 that it plans to launch REAL-AF (Registry to evaluate anticoaguLation in atrial fibrillation), a USA based registry to evaluate patterns in the present practice of anticoagulation in 2,500 patients with nonvalvular atrial fibrillation.
The registry, which will be led by an outside committee of expert advisers, will enroll patients prospectively and analyse data from patients retrospectively.
Anticoagulant therapy reduces the incidence of stroke by up to 60%. However, there is a need for accurate data to define the patterns of current use and management of anticoagulation in patients with atrial fibrillation who are treated in ordinary community medical practices.
In this registry, Boehringer Ingelheim plans to enroll 1,500 atrial fibrillation patients prospectively at roughly 250 general and cardiology practices across the country. In addition, retrospective data will be analysed from 1,000 patients from the same clinical sites. The registry is designed to provide a better understanding of patient characteristics and risk factors, clinical outcomes (e.g., ischaemic stroke, other thromboembolic events and bleeding) and healthcare resource utilisation associated with the initiation of anticoagulation treatment in nonvalvular atrial fibrillation.
Analyses of retrospective data, including a medical claims database review presented at the 58th Annual Scientific Session of the American College of Cardiology in Orlando, USA, suggest that many patients with atrial fibrillation who are potentially eligible for anticoagulation therapy for stroke prevention are not treated. The data from REAL-AF should contribute to our understanding of current treatment trends.
A Boehringer Ingelheim sponsored, retrospective analysis of medical claims from a nationally representative group of USA managed care plans (from January 2001 to December 2006), was presented at the American College of Cardiology meeting. The analysis of data from more than 50,000 patients with atrial fibrillation not associated with valvular disease found that less than half (41.9%) of patients potentially eligible for anticoagulation therapy for stroke prevention received it. Patients were considered eligible for anticoagulant therapy if they were at moderate to high risk for stroke and lacked any evidence of contraindication to treatment.
“This medical claims database review found that anticoagulation therapy was not used as widely or effectively as it could have been for stroke prevention in atrial fibrillation patients,” said Dr Gregory P Samsa, Duke University Medical Center and co-investigator of the study. “These results are consistent with several other analyses showing that many atrial fibrillation patients who are at increased risk for stroke do not receive treatment with anticoagulants.”