Non-valvular atrial fibrillation (NVAF) is a heart disorder, which affects the pumping of blood. This disturbance in blood flow can allow clots to form where the blood moves too slowly. These clots can cause potentially deadly blockages in blood vessels supplying the brain resulting in stroke. NVAF patients are therefore often prescribed medicines that reduce how much blood clots and lowers the risk of stroke. However, use of some of these drugs requires routine monitoring of patients while they are on treatment, which is time consuming. Clinical trials have shown that newer medicines may be just as effective as conventional treatments, but do not require regular monitoring, making treatment simpler and reducing the likelihood that a patient will discontinue treatment. An understanding of the long-term use of these medicines when used in the real world is lacking. In order to provide more information on the use of these medicines we propose to investigate the characteristics of NVAF patients given these medicines, the length of time they use the medicines and how many healthcare interactions they have whilst using these medicines. This study will provide a better understanding of how these medicines are used in England.
Novel Oral Anticoagulants (NOACs) have at least equivalent effectiveness and improved safety in comparison to Vitamin K antagonists (VKA) such as warfarin. NOACs do not require regular monitoring of coagulation levels, making treatment simpler and potentially more convenient for patients. These characteristics may in turn improve treatment adherence.
We will use a cohort study design of patients with non-valvular atrial fibrillation (NVAF) newly prescribed NOACs in routine clinical practice in England, identified from retrospective data from the Clinical Practice Research Datalink, Hospital Episode Statistics and Office for National Statistics. This study aims to describe the characteristics, treatment patterns and healthcare resource use (HCRU) of patients with NVAF in England who are newly prescribed apixaban, rivaroxaban, dabigatran or warfarin. The risk of treatment discontinuation will be investigated by treatment class using Kaplan-Meier and Cox-regression analyses. The frequency of all-cause and NVAF-related HCRU will be described and rates of use by person-time will be reported. Multivariable modelling will be used to estimate the association of OAC treatment with the rate of HCRU, while controlling for possible confounding factors.
Oral anticoagulant treatment discontinuation (including treatment cessation, treatment interruption and treatment switching)
- For both all-cause and NVAF-related:
Hospitalisations
Hospital length of stay (LOS)
Number of GP / nurse visits
Number of outpatient visits to the specialist, in particular to the cardiologist
Mireia Raluy Callado - Chief Investigator - Evidera, Inc
Robert Carroll - Corresponding Applicant - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Beth Nordstrom - Collaborator - Evidera, Inc
Nathan Hill - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Robert Donaldson - Collaborator - Evidera Ltd - UK
Sophie Graham - Collaborator - Evidera, Inc
Sreeram Ramagopalan - Collaborator - London School Of Economics & Political Science
HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation