People with non-valvular atrial fibrillation, a common heart rhythm disorder, have high risk of stroke and should be prescribed medicines which reduce blood clotting (oral anticoagulants) to lower this risk. However, use of these drugs can result in bleeding. We will describe occurrence of newly diagnosed ischemic stroke, the most common type of stroke, and hospitalizations for bleeding among people with non-valvular atrial fibrillation. We will study occurrence of such events by age, gender, ethnicity, calendar year of atrial fibrillation diagnosis, use of oral anticoagulants, stroke and bleeding risk at study entry, geographic area, deprivation and frailty. We will also study mortality in this population. Our study will allow us to better understand burden of non-valvular atrial fibrillation.
Study objective: to describe incidence of major bleeding events and ischemic stroke in a recent population of patients with non-valvular atrial fibrillation (NVAF) using UK CPRD linked to England Hospital Episode Statistics (HES). Methods: A retrospective cohort study among adult patients with newly diagnosed NVAF between Jan, 2011 - Dec, 2015 (or up to the most recent data available). The linked HES and ONS mortality data will be used to study ischemic stroke and major bleeding outcomes. Analysis: After describing baseline patients' characteristics, we will estimate crude, age, gender, calendar year specific incidence rates and their 95 % confidence intervals. The rates will be stratified by age, gender, ethnicity, calendar year of atrial fibrillation diagnosis, use of oral anticoagulants, stroke and bleeding risk at study entry, geographic area, deprivation and frailty. All-cause mortality and mortality from ischemic stroke and major bleeding will be estimated. Our study will present an up-to-date landscape of ischemic stroke and major bleeding events in an incident NVAF population.
Primary outcomes: Ischemic stroke; Major bleeding.
Secondary outcomes: Deaths; Fatal ischemic stroke; Fatal major bleeding.
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Farnaz Vahidnia - Chief Investigator - Roche
Nadia Foskett - Corresponding Applicant - UCB BioSciences, Inc.
Ameet Bakhai - Collaborator - Royal Free London NHS Foundation Trust
Fabian Wiktorowski - Collaborator - Roche
Frank Corvino - Collaborator - Genesis Research LLC
Hans Petri - Collaborator - Petri Consulting Ltd
Marcus Hibell - Collaborator - Roche
Mark John Sculpher - Collaborator - University of York
Matthew McEnany - Collaborator - Genesis Research LLC
Nadia Foskett - Collaborator - UCB BioSciences, Inc.
Yingjie Ding - Collaborator - Genesis Research LLC
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Practice Level Index of Multiple Deprivation