Heart and blood vessel diseases (including heart attacks and strokes) are known as cardiovascular diseases and these diseases are the leading cause of death in England and Wales, accounting for almost 1/3 of all deaths. More than 1.7 million admissions in NHS hospitals in the UK annually are related to cardiovascular disease. There is however a lack of recent data on the characteristics of patients suffering from heart attacks, and what the risks are for having another heart attack or other cardiovascular disease (for example stroke) after having your first heart attack. Treatments to prevent subsequent cardiovascular disease may cause bleeding as a side effect. It is therefore important to understand what the risks of cardiovascular disease and bleeding events are and what leads some people to have additional cardiovascular or bleeding events so future research can try to prevent such events. The aims of this study are therefore to investigate the profile of patients having a heart attack, to quantify subsequent cardiovascular disease and bleeding events in these patients, to investigate risk factors for these events, and to understand the overall benefit treatments may provide for such patients.
Patients with a history of myocardial infarction (MI) are at substantial risk of future atherothrombotic events (e.g., repeated MI, stroke, and cardiovascular [CV] death). Antithrombotic therapy is widely used to reduce the risk of subsequent ischemic events, but is known to increase the risk of bleeding among treated patients. A new treatment for secondary prevention of atherothrombotic events, called vorapaxar, has completed phase 3 trials in 2012. It is unclear how much the randomized controlled trial population, differs from the general population, how this subsequently impacts atherothrombotic risks, and how antithrombotic treatment may benefit patients in the real-world setting. Therefore, the purpose of this study is to investigate risks of subsequent atherothrombotic and bleeding events in patients with prior MI, matched and unmatched to those patients eligible for the vorapaxar trial, to determine risk factors for these events in these populations, and to quantify net clinical benefit of antithrombotic treatment in the real-world setting. To ensure all exposures and outcomes of interest are well-captured in this study, data from CPRD will be linked with data from HES, MINAP, and the ONS mortality register.
All-Cause Mortality ; Cardiovascular (CV) death; CV death, excluding fatal bleed; Myocardial Infarction (MI); Non-fatal MI; Stroke; Ischemic stroke (IS); Non-fatal IS; Non-fatal intracerebral hemorrhage (ICH); Severe bleed, non-fatal, non-ICH; Moderate or severe bleed; Moderate bleed; Severe bleed; Fatal bleed
Dimitra Lambrelli - Chief Investigator - Evidera, Inc
Dimitra Lambrelli - Corresponding Applicant - Evidera, Inc
Cathy Anne Pinto - Collaborator - Merck Sharp & Dohme - UK
Laura McDonald - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Robert Donaldson - Collaborator - Evidera Ltd - UK
Sharon MacLachlan - Collaborator - Evidera, Inc
Tommi Tervonen - Collaborator - Evidera, Inc
HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;MINAP