Peripheral arterial disease is a common circulatory problem in which narrowed arteries reduce blood flow to the limbs and is reported to affect about 13% of people aged greater than 50 years in Western Europe and North America. It is now well established that symptoms and severity of this condition are major determinants of subsequent higher risk of cardiovascular events (such as heart disease, stroke, heart attack and angina) and death. Most recent estimates suggest that peripheral arterial disease has now reached pandemic proportion, with more than 200 million people living with this condition worldwide. Despite being common and increasing the risk of death, peripheral arterial disease attracts less attention in terms of research, early detection, and treatment. In particular, there is not a lot of information for patients with peripheral arterial disease who underwent recent revascularization procedures to restore blood flow to blocked arteries in terms of frequency of the disease, patient characteristics, treatment patterns, and survival. This study is aimed to estimate the burden of lower extremity revascularization related to peripheral arterial disease in England in terms of characteristics of patients, the incidence of complications, health resource utilization related to complications, and treatment patterns. Additionally, the incidence of revascularization, baseline characteristics, treatment pattern, and risk/incidence of complications will be assessed among subgroups of interest including a subset of patients matching the characteristics of a particular clinical trial.
Two sets of patient cohorts will be needed to answer the study questions. One cohort which will be used to calculate incidence of first-time ever PAD related revascularization (overall and by type of procedure), will include all incident patients diagnosed with PAD above the age of 18 years and registered with a general practice for at least one year. These patients will be followed-up until the occurrence of any revascularization procedure or a major study end point (i.e. the patient disenrolls from the practice or the practice disenrolls from CPRD, the patient dies, end of the study period on 31st December 2018). Demographics, health behaviors (e.g. smoking, alcohol consumption) and clinical characteristics will be described over a 1-year period prior to the index date.
Patients will enter the second cohort if they underwent a PAD related revascularization. The second cohort will be used to estimate the incidence of revascularization re-occurrence, the risk/incidence of PAD-related complications as well as to describe health resource utilization (HRU) and treatment patterns. Differences in patient characteristics, disease complications, health resource utilization, and treatment patterns will be also explored among subgroups of patients with PAD related revascularization. The study will be undertaken utilizing linked data within the Clinical Practice Research Datalink with Hospital Episode Statistics (HES) and Office for National Statistics (ONS) databases.
Incidence of first-time ever PAD related revascularizations and incidence of revascularization re-occurrence, overall and by type of procedure
Treatment patterns (with a focus on standard of care) in patients with PAD related revascularizations
Risk and incidence of complications (e.g. major cardiovascular events, bleeding) among patients with PAD related revascularizations
Health resource utilisation (HRU) related to PAD complications in patients with PAD related revascularizations
Risk/incidence of complications, HRU and treatment patterns among subgroups of interest
Jennifer Quint - Chief Investigator - Imperial College London
Laura Portas - Corresponding Applicant - Imperial College London
Alexander Cohen - Collaborator - King's College London (KCL)
Jean Baptiste Briere - Collaborator - Bayer AG
Rupert Martin Bauersachs - Collaborator - Klinikum Darmstadt GmbH
Varun Sundaram - Collaborator - Imperial College London
William Schuyler Jones - Collaborator - Duke University
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation