Patients who survive a hospitalization for heart or blood-vessel diseases are at greater risk of recurrent cardiovascular (CV) related death, heart attack (myocardial infarction), and stroke. Medications used to reduce the risk of such CV events are based upon clinical trials, which have populations enriched with specific criteria and with a much higher utilization of these drugs. Therefore, there are limited information on how these results extend to the entire population. This study will use anonymized information routinely collected during general practice visits and hospital stays, and from death certificates to assess the number of CV events such as heart attack, stroke, and CV death in a population experiencing a heart or blood vessels related hospitalization in the United Kingdom. We will also assess which factors, for instance, age, sex, concomitant hypertension or diabetes, are associated with recurrent CV related hospitalizations or death. Lastly, we will observe which treatments were prescribed over time and the associated level of fat molecules called low-density lipoprotein cholesterol.
The planned study design is a longitudinal retrospective observational cohort study based on a population with an acute coronary syndrome (ACS) hospitalization determined from Hospital Episode Statistics (HES) database in the United Kingdom. This database as well as the Clinical Practice Research Datalink (CPRD) database will be utilized for baseline characteristics such as laboratory measures or comorbidities. CPRD database will be utilized to study treatment patterns and achieved low-density lipoprotein cholesterol (LDL-C) over time, and HES and Office for National Statistics (ONS) databases to follow up the study outcomes. Primary objective and first secondary objective will describe event rates over time for the primary and secondary outcomes (cardiovascular (CV) events) via Kaplan-Meier analyses. Possible risk factors for the primary and secondary outcomes will be assessed via a Cox proportional hazards model and will include patient demographics, clinical characteristics, laboratory measures, lifestyle, and medication characteristics. Summary statistics of these variables will be provided as part of the second secondary objective. To address the last secondary objective, proportion of patients on various therapies, proportion of patients within categories of achieved LDL-C, rates of all possible treatment-related events including treatment initiation, intensification, discontinuation, and re-start, and LDL-C levels will be described. Analyses will be provided for the whole study population and separately for each subgroup of interest (CV risk score at index, index ACS type, treatment with revascularization for index ACS, evidence for diabetes mellitus prior to index, evidence for coronary heart disease prior to index ACS, evidence for ischemic cerebrovascular disease prior to index ACS, evidence for peripheral arterial disease prior to index ACS, and evidence for ACS events within 12 months prior to index ACS).
Primary outcomes will be defined as the composite of nonfatal myocardial infarction (MI), nonfatal ischemic stroke, and cardiovascular (CV) death.
Secondary outcomes will be defined as nonfatal MI, nonfatal ischemic stroke, CV death, unstable angina hospitalization, and elective coronary revascularization as a composite outcome and separately, and all-cause mortality.
Descriptive variables during the follow-up will be lipid lowering therapies (LTT) (including statins, ezetimibe, and PCSK9 inhibitors) and achieved low-density lipoprotein cholesterol (LDL-C) levels.
Pia Horvat - Chief Investigator - IQVIA Ltd ( UK )
Christopher Lee - Corresponding Applicant - IQVIA Ltd ( UK )
Alexandra Koumas - Collaborator - Axtria Inc. USA
Ankita Chauhan - Collaborator - Axtria Inc. USA
Anna Castelo Branco - Collaborator - IMS Health Sweden AB
Aurore Tricotel - Collaborator - IQVIA Operations France SAS
Christian Siegfried - Collaborator - Axtria Inc. USA
Christopher Lee - Collaborator - IQVIA Ltd ( UK )
Emil Vatov - Collaborator - IQVIA Solution Bulgaria EOOD
Gianluca Lucrezi - Collaborator - IQVIA AG (Switzerland)
Jessica Lundbom - Collaborator - IQVIA Ltd ( UK )
Louise Raiteri - Collaborator - IQVIA Ltd ( UK )
Nelly Ly - Collaborator - IQVIA Ltd ( UK )
Nicole Rutishauser - Collaborator - IQVIA II Technology Solutions Portugal, Unipessoal LDA
Oriane BRETIN - Collaborator - IQVIA Operations France SAS
Quratul Ann - Collaborator - IQVIA Ltd ( UK )
Sophia Rodopoulou - Collaborator - IQVIA Hellas Technology Solutions S.A.
Stavros Oikonomou - Collaborator - IQVIA Solution Bulgaria EOOD
Sushant Pal - Collaborator - Axtria India Pvt. Ltd.
Tarana Mehdikhanova - Collaborator - IQVIA Ltd ( UK )
Vanessa Marzola - Collaborator - IMS Health Sweden AB
Cecilia Lourdudoss - Collaborator - IMS Health Sweden AB
Gianluca Lucrezi - Collaborator - IQVIA
Jessica Lundbom - Collaborator - IQVIA Ltd ( UK )
Pia Horvat - Collaborator - IQVIA Ltd ( UK )
Sarah Jenner - Collaborator - IQVIA Ltd ( UK )
HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation