Estimating Incidence and Prevalence of Atherothrombotic Events in Coronary Artery Disease, Peripheral Artery Disease and Ischaemic Stoke Patients on Standard of Care Antiplatelet Treatment: a England Cohort Study

Date of Approval: 
2020-11-11 00:00:00
Lay Summary: 
Cardiovascular disease is a disease of the heart and cardiac system and impacts a significant proportion of the global and the UK population. Coronary artery disease (CAD), peripheral artery disease (PAD), and ischaemic stroke (IS) are all forms of cardiovascular disease which can lead to adverse cardiac events such as heart failure, nonfatal myocardial infarction and potentially death. The development of treatment medications, such as statins, and other therapies has remarkably decreased cardiovascular deaths however, some patients continue to experience adverse cardiac events, such as heart attacks, stroke, and death, while on these medications. A clinical trial completed by Bayer showed that the addition of a new treatment, rivaroxaban, in combination with aspirin could decrease adverse cardiac events, such as heart attacks, stroke, and death, in CAD, PAD, and IS patients whose conditions are not managed on current standard of care treatments. This medication could significantly improve cardiovascular care and decrease deaths. Using real world data, this study aims to quantify how many CAD, PAD, and IS patients continue to experience adverse cardiac events while on standard treatment and what outcomes they experienced over the course of care. Examining this subset of patients will demonstrate what proportion of CAD, PAD, and IS patients are not benefitting from current standard of care treatments. This will improve the understanding of patient outcomes where current standard of care is not enough and increase overall care in cardiac disease treatment.
Technical Summary: 
Coronary artery disease, peripheral artery disease, and ischaemic stroke are three forms of atherosclerotic cardiovascular disease which is a primary cause of mortality and morbidity across the world. While current standard of care treatment has been beneficial, there are many CAD, PAD, and IS patients who go on to have further cardiac events and would benefit from supplemental therapies. This study aims to quantify the residual risk of adverse cardiac events while on standard of care antiplatelet monotherapies in these three subgroups. This study will be a descriptive, retrospective cohort study in order to analyse incidence and prevalence of major adverse cardiac events (MACE) and major adverse limb events (MALE) for each of the three subgroups, CAD, PAD and ischaemic stroke. As secondary objectives standard of care antiplatelet treatment patterns, patient characteristics at index date, and cause specific hospitalisations and medical procedures will be analysed and summarised in descriptive tables. Temporal trends by calendar year of index will also be described by patient characteristics at index date and treatment patterns and will stratified by appropriate subgroups. Descriptive analysis will be performed overall and in subgroups, by type of previous cardiovascular event (CAD, ischaemic stroke or PAD).
Health Outcomes to be Measured: 
1. Major Adverse Cardiac Events 2. Major Adverse Limb Events
Application Number: 

Naomi Boxall - Chief Investigator - IQVIA
Esther Tolani - Corresponding Applicant - IQVIA
Ben Bray - Collaborator - IQVIA
Caroline O'Leary - Collaborator - IQVIA
Pesheya Doubleday - Collaborator - IQVIA - UK
Peter McMahon - Collaborator - IQVIA - UK
Rachel Tham - Collaborator - IQVIA
Suvi Hokkanen - Collaborator - IQVIA

HES Admitted Patient Care;HES Outpatient;Patient Level Index of Multiple Deprivation