Utilization of Standard and Target-Specific Oral Anticoagulants among Adults in the United Kingdom with Incident Non-Valvular Atrial Fibrillation

Study type
Protocol
Date of Approval
Study reference ID
15_224
Lay Summary

Oral anticoagulants are commonly used to prevent strokes in patients with a common heart rhythm disorder called atrial fibrillation. For over 50 years, warfarin was the only oral anticoagulant available in the UK. Although warfarin is still widely used, three new and more convenient oral anticoagulants were approved for use starting in 2013. Because all oral anticoagulants can increase the chances of serious bleeding, physicians identify patients who are most likely to benefit from using these medicines. To do this, physicians use an individual’s medical history to estimate the risk of stroke. A new risk scoring system was published at the same time the new medicines were introduced in the UK. These two advances have the potential to improve the quality of care of patients with atrial fibrillation. The goal of this study is to examine how the use of the different oral anticoagulants has changed since the new medicines became available and the new risk scoring system was published. This study will identify whether these two advances have improved the quality of care by describing the characteristics of patients who receive oral anticoagulants and examining how soon treatment decisions are made after a diagnosis of atrial fibrillation.

Technical Summary

Two recent developments in atrial fibrillation (AF) — new therapeutic options and updated risk stratification — have the potential to improve the quality of care of patients with AF. The objectives of this study are to describe the time from AF diagnosis to oral anticoagulant (OAC) initiation, examine the patient characteristics associated with treatment choice, and describe the timing and cumulative incidence of switching OACs. To address these objectives we will identify a cohort of patients with incident AF between 2010 and 2014 who were potential candidates for a target-specific OAC. The dependent variables include the time from diagnosis to OAC initiation, the first selected treatment within the first 90 days of diagnosis, and the time from first OAC initiation to switch to a different OAC. Independent variables include factors associated with increased risk of stroke, factors associated with increased risk of bleeding, and other potential contraindications. The time from diagnosis to OAC initiation and time from OAC to OAC switch will be analyzed using the Kaplan-Meier estimator. Associations between the selected treatment and each of the independent variables will be evaluated using logistic regression.

Collaborators

Morris Weinberger - Chief Investigator - University of North Carolina at Chapel Hill
Todd Durham - Corresponding Applicant - IQVIA - USA (Headquarters)
Anthony Viera - Collaborator - University of North Carolina at Chapel Hill
Jason Fine - Collaborator - University of North Carolina at Chapel Hill
Jayanti Mukherjee - Collaborator - Bristol-Myers Squibb - USA ( BMS )
Kristen Hasmiller Lich - Collaborator - University of North Carolina at Chapel Hill
Stacie Dusetzina - Collaborator - University of North Carolina at Chapel Hill

Linkages

HES Admitted Patient Care