Sex-specific differences in cardiovascular risk factors, risk factor management, treatment compliance and major cardiovascular outcomes in the peripheral arterial disease population

Study type
Protocol
Date of Approval
Study reference ID
23_002924
Lay Summary

Cardiovascular disease, (namely disease of the blood vessels supplying the heart, body and brain,) is often regarded as a man’s problem, but is also the main cause of death for women.

Certain medical conditions and lifestyle choices (so called “risk factors”) increase the risk of cardiovascular disease. When they are spotted, they can often be treated to prevent further illness and death. These include “traditional” risk factors, such as high blood pressure and smoking, as well as newly recognised conditions, which may be more common in either women or men.

We have noticed that women with peripheral arterial disease, (disease in blood vessels supplying the stomach, arms and legs) often do worse than men. This may be due to differences in their risk factors and treatment. For this study we will use depersonalised (non-identifiable) data collected from medical records, in particular data from GPs (general practitioners), to look at the differences in risk factor treatment and the importance of risk factors for men and women.

Understanding the differences in risk factors and their management, for men and women, could help us to spot and treat them more successfully. This could reduce the burden of cardiovascular disease for people in the future.

Technical Summary

Background:
Morbidity from peripheral arterial disease (PAD) causes a worldwide health economic burden and is associated with morbidity and death from other cardiovascular disease (CVD). Women with PAD fare worse than men. This may occur due to differences in recognition and management of CVD risk, for traditional and non-traditional risk factors (NTRF). These differences are poorly understood.

Aims:
To investigate the hypotheses that:
(1) sex specific differences in cardiovascular risk management leads to disparity in disease progression, major cardiovascular events, and death, amongst those with PAD
(2) non-traditional risk factors contribute to sex-specific differences observed.

Methods:
A retrospective population-based cohort study using linked de-personalised electronic healthcare records (Clinical Practice Research Datalink, Hospital Episode Statistics, Index of Multiple Deprivation, Office of National Statistics), 2010-2020. Evaluation of cardiovascular risk management received by women and men with PAD, and impact on clinical outcomes, adjusting for traditional and non-traditional risk factors. Longitudinal assessment of patients with pre-selected NTRFs, identified prior to diagnosis of CVD, (comparing to age-matched controls), to establish associated risk of PAD.

Impact:
Understanding the impact of sex-specific differences in recognition and management of CVD risk will enable quality improvement in risk stratification and treatment for the PAD cohort, especially for women.

Health Outcomes to be Measured

• Major Adverse Cardiovascular Event or Death:
defined as any of the following:
(A) Critical limb ischaemia, intervention/bypass, or amputation,
(B) Aortic repair or rupture,
(C) Major cardiac event – myocardial infarction,
(D) Ischaemic stroke or carotid surgery,
(E) Diagnosis of vascular dementia
AND/OR (all cause or cardiovascular) mortality.

• Progression of disease (PAD or IHD) to end organ damage, with adjustment for baseline disease severity at index data entry, please see appendix 1.

Collaborators

Anna Louise Pouncey - Chief Investigator - Imperial College London
Anna Louise Pouncey - Corresponding Applicant - Imperial College London
Colin Bicknell - Collaborator - Imperial College London
Jaet Powell - Collaborator - Imperial College London
Mahsa Mazidi - Collaborator - Imperial College London
Mark Cunningham - Collaborator - Imperial College London
Mark Woodward - Collaborator - Imperial College London
Misghina Weldegiorgis - Collaborator - Imperial College London
Safa Salim - Collaborator - Imperial College London

Linkages

HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation