RIPCORD 2: A randomised controlled trial comparing routine pressure wire assessment with conventional angiography in coronary artery disease - 5-year long-term follow-up

The data will be used for the purposes of the following research project:

RIPCORD 2: A randomised controlled trial comparing routine pressure wire assessment with conventional angiography in coronary artery disease - 5-year long-term follow-up.

The 5-year long-term follow-up study will be conducted by University Hospital of Southampton (UHS) as the sole controller. Liverpool Heart & Chest Hospital (LHCH) were involved in the initial trial but are not involved in controllership or processing activities for the 5-year follow-up study.

The following is a summary of the aims of the 5-year long-term follow-up study provided UHS:

The extended follow-up at 5-years aims to provide robust evidence on the long-term safety and clinical effectiveness of fractional flow reserve (FFR). UHS will conduct a long-term follow-up of RIPCORD 2 participants to evaluate clinical outcomes over a 5-year period post-randomisation. The study will focus on:

• All-cause mortality;

• Cardiovascular-specific mortality;

• Major adverse cardiovascular and cerebrovascular events (including myocardial infarction, stroke, and revascularisation);

• Hospital admissions for cardiac causes (e.g. arrhythmia, chest pain);

• Admission to hospital with cerebrovascular accident

University Hospital Southampton NHS Foundation Trust (UHS) will transfer data to NHS England. The data will consist of identifying details (NHS Number, Date of Birth, and a unique person ID) for the cohort to be linked with NHS England data.

NHS England will provide the relevant records from the Civil Registration Mortality and HES Admitted Patient care datasets to UHS. The Data will contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient.

The Data will not be transferred to any other location.

The Data will be stored on servers at University Hospital UHS.

UHS will back-up the Data using UHS owned servers.

The Data will be accessed by authorised personnel onsite at UHS only.

The Data will not leave England at any time.

Access is restricted to substantive employees of UHS who have authorisation from the Chief Investigator.

LHCH is not permitted to access the Data.

The Data will not be linked with initial trial data supplied by NHSE which is archived at Liverpool Heart & Chest Hospital under DARS-NIC-303379-H4C8H-v2.

The identifying details will be stored in a separate database to the linked dataset used for analysis. All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.

The expected outputs of the processing will be:

• Submissions to peer reviewed cardiology journals are expected by February 2027.

• Presentations at major national and international cardiology conferences such as the American College of Cardiology (ACC) or European Society of Cardiology (ESC).

• Publication on cardiology-related websites and professional social media platforms.

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:

• Journals

• Cardiology related websites

• Social media

The target date for dissemination of outputs is February 2027.

The findings of this research study are expected to contribute to evidence-based decision-making for policy-makers, local decision-makers such as doctors, and patients to inform best practice to improve the care, treatment and experience of health care users relevant to the subject matter of the study.

The use of the data could:

• help the system to better understand the health and care needs of populations.

• lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.

• inform planning health services and programmes, for example to improve equity of access, experience and outcomes.

• inform decisions on how to effectively allocate and evaluate funding according to health needs.

• provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from, or areas of poorer practice which need to be addressed.

The findings could have a profound impact on cardiology practice by informing clinical decision-making and guidelines at both national and international levels. Given the high prevalence of coronary artery disease and the large numbers of patients undergoing invasive coronary procedures worldwide, these results have the potential to influence the care of thousands of patients annually.

It is hoped that through publication of findings in appropriate media, the findings of this research will add to the body of evidence that is considered by the bodies, organisations and individual care practitioners charged with making policy decisions for or within the NHS or treatment decisions in relation to specific patients.

Clients will need to take action based on the information provided to them in order to realise the potential improvement opportunities. For example, findings from this extended follow-up have the potential to influence clinical practice guidelines nationally and internationally, informing policy bodies such as the National Institute for Health and Care Excellence (NICE) and the European Society of Cardiology (ESC).

The primary RIPCORD 2 trial paper has been published in circulation, a leading cardiology journal: Routine Pressure Wire Assessment Versus Conventional Angiography in the Management of Patients With Coronary Artery Disease: The RIPCORD 2 Trial (ahajournals.org).

The findings have helped guide clinicians on the appropriate use of pressure wire technology, with the potential to benefit thousands of patients undergoing coronary angiography and revascularisation procedures each year.

Additionally, the innovative methodology developed for outcome ascertainment using linked Hospital Episode Statistics (HES) and mortality data has paved the way for more efficient, cost-effective cardiovascular research studies within the NHS and beyond.

The ongoing extended follow-up at 5-years will further enhance understanding of the long-term clinical impact of FFR-guided management, supporting improvements in patient care and informing future clinical guidelines.