Atrial fibrillation (AF) is typically characterized by an irregular and rapid heartbeat and affects 1.4 million patients in the UK with 20-30% of strokes are attributable to AF. Blood clots are a major factor in the risk of stroke and so patients with AF are treated with drugs known as oral anticoagulants to prevent blood clots. Recently a new generation of novel antagonist oral anticoagulant’s (NOAC) have been used which are also easier to use and are less likely to cause a bleed a problem with warfarin commonly used to for patients with AF. In this study, we aim to compare the effectiveness of NOAC drugs to assess whether the benefit observed in trails can be found in clinical practice.
Research-quality patients with nonvalvular atrial fibrillation on a NOAC treatment between January 2009 and March 2022 will be selected. The number of people who develop outcomes of interest including stroke, heart attacks, a major bleeds or death will be calculated. Time to these endpoints and patients’ characteristics will be presented.
Atrial fibrillation (AF) is a condition that causes an irregular heart rhythm and often rapid heartbeat with symptoms including shortness of breath, heart palpitations and dizziness. Treatment for AF includes novel antagonist oral anticoagulant’s (NOAC’s) which work by preventing blood clotting, a major associating risk factor for stroke. Patient with AF are five times more likely to experience a stroke and have a two-fold increase in death.
Acceptable patients will be selected from the CPRD Aurum and linked Hospital Episode Statistics and Office of National Statistics mortality datasets if they have their first prescription for one of four NOAC’s between January 2009 and March 2022. The four NOACs are Apixaban, Dabigatran, Edoxaban & Rivaroxaban. Index date will be set as date of first prescription in the study period and patients will be followed up until the earliest of patient’s transfer-out date, date of death (if applicable), and the last data-collection date for their practice. Patients will be required to have at least one medical encounter in the 180 days prior to study index date, be at risk of stroke and have no recorded history of study outcomes. A 365-day wash in for prior NOAC use will be used to ensure newly initiated prescription are selected. Endpoints of interest will include ischaemic or haemorrhagic stroke, myocardial infarction (MI), major bleeding events, transient ischemic attack, all-cause mortality, and a composite of angina/MI/stroke and will be analysis and presented using Kaplan–Meier analysis and cox regression models. Patients will be matched to a patient with another NOAC using propensity score matching. This study will provide valuable information on the efficacy, cost effectiveness and safety of patients who use NOACs and help to inform healthcare decision-making.
Patient characteristics; drug utilization; nonvalvular atrial fibrillation, ischemic or haemorrhagic stroke; myocardial infarction (MI); transient ischemic attack (TIA); Major bleeding events; composite of angina/MI/stroke; all-cause mortality; Comorbidities.
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Elgan Mathias - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Bethan Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Ellen Hubbuck - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Leah Fisher - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Rhiannon Thomason - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Practice Level Index of Multiple Deprivation