Risk and Benefit Stratification of Treatment Effects in Patients with Atrial Fibrillation

Lead Investigator: Changyu Shen, Beth Israel Deaconess Medical Center
Title of Research Proposal: Risk and Benefit Stratification of Treatment Effects in Patients with Atrial Fibrillation
Vivli Data Request: 3876
Funding Source: Government Funding: National Institute of Health T32 Research Fellowship (7/1/2018-6/30/2020) for Dr. Usman Tahir
Potential Conflicts of Interest: None
Summary of the Proposed Research:

Patients with atrial fibrillation often require anticoagulation in order to prevent stroke or systemic embolic events (1). While often necessary, anticoagulation increases the risk that patients experience a clinically significant bleeding event (2). Identifying patients that undergo different treatment benefit or harm with anticoagulation can identify patients more likely to benefit by or more likely to be harmed by anticoagulation strategy (3). Appropriate selection of anticoagulation agent and dose is of high importance to maximize the benefit-to-risk ratio. The goal of our research is to identity differences in patient benefits and patient risks with anticoagulation for atrial fibrillation.
We will be developing a prediction scheme to identify the risk of bleeding for patients with atrial fibrillation who receive anticoagulation. We will also assess for differing responses in treatment benefits (i.e., ischemic or embolic/stroke reduction) and treatment harms (i.e., bleeding risks) based on individual patient characteristics. This will be done by leveraging individual patient data from randomized trials of anticoagulation use in patients with atrial fibrillation.

Requested Studies: