Identification of patients at risk of cardiovascular disease in Greater Manchester in the VICTORION-Spirit study
DOI:
https://doi.org/10.18203/2349-3259.ijct20240038Keywords:
Inclisiran, Cardiovascular disease, Implementation scienceAbstract
Background: Inclisiran is a cholesterol-lowering small interfering RNA treatment licensed in the UK for lowering low-density lipoprotein cholesterol (LDL-C). VICTORION-Spirit (NCT04807400) is an implementation science study designed to provide evidence for inclisiran implementation within the National Health Service. The aim was to describe the process of patient identification employed in VICTORION-Spirit.
Methods: A Phase IIIb, multicentre, randomised controlled study, VICTORION-Spirit is evaluating inclisiran implementation in participants with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents and elevated LDL-C. Feasibility Assessment and Recruitment System for Improving Trial Efficiency (FARSITE) software utilising natural language search functions identified patients who may benefit from inclisiran. FARSITE searches were performed within Salford, Manchester, Trafford and Bury Clinical Commissioning Groups to identify individuals with elevated LDL-C or total cholesterol and pre-existing cardiovascular disease (CVD) or at risk of ASCVD.
Results: FARSITE used ‘total cholesterol >4 mmol/l’ terminology rather than ‘LDL-C’; the former yielded >3 times the number of eligible patients. The search for individuals with pre-existing CVD identified 24,196 people in a population of 560,969 (4.3%); including ‘total cholesterol >4 mmol/l’ identified 10,431 individuals with pre-existing CVD and elevated total cholesterol. Searches for individuals at risk of ASCVD identified 65,457 people, narrowing to 26,580 at risk of ASCVD plus elevated total cholesterol. The most discriminatory SNOMED concept codes and their prevalence within the dataset can inform national approaches to develop similar searches.
Conclusions: FARSITE searches employed in VICTORION-Spirit identified a population at risk of ASCVD in Greater Manchester, England, who may benefit from a cholesterol-lowering medication such as inclisiran.
References
NHS England. Our work. Living well, ageing well and tackling premature mortality: cardiovascular disease. 2022. Available at: https://www. england.nhs.uk/ourwork/clinical-policy/cvd/. Accessed on 09 February 2022.
NHS England. Summary of national guidance for lipid management for primary and secondary prevention of CVD. 2021. Available at: https://www.england.nhs.uk/aac/wp-content/ uploads/sites/50/2020/04/Summary-of-national-guidance-for-lipid-management-for-primary-and-secondary-prevention-of-cardiovascular-disea.pdf. Accessed on 12 February 2022.
Lamb YN. Inclisiran: first approval. Drugs. 2021;81:389-95.
Electronic Medicines Compendium. Leqvio 284 mg solution for injection in pre filled syringe. Available at: https://www.medicines.org.uk/emc/ product/ 12039/smpc#gref. Accessed on 17 June 2022.
Novartis Pharmaceuticals. Leqvio (inclisiran) Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/leqvio-epar-product-information_en.pdf. Accessed on 13 May 2022.
Ray KK, Wright RS, Kallend D, Koenig W, Leiter LA, Raal FJ, et al. Two phase 3 trials of inclisiran in patients with elevated LDL cholesterol. N Engl J Med. 2020;382:1507-19.
National Association of Primary Care (NAPC). Primary care home: population health management. 2018. Available at: https://napc.co.uk/wp-content/uploads/2019/08/NAPC-Population-heath-guide-web.pdf. Accessed on 04 March 2022.
NHS. Accelerated Access Collaborative. What we do. Introducing revolutionary medicines to the NHS. Commercial partnerships. 2022. Available at: https://www.england.nhs.uk/aac/what-we-do/introducing-revolutionary-medicines-to-the-nhs/commercial-partnerships/. Accessed on 30 May 2022.
Dixon S, Rootkin L, Vell T. Inclisiran: testing a population health management methodology to implement a novel lipid treatment. Br J Cardiol. 2021;28(2):S19-22.
Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012;50:217-26.
Wilson PM, Dixon S, Vell T, Bower P, Rootkin L, Williams C, et al. Implementation of inclisiran in UK primary care for patients with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents: rationale and design of VICTORION-Spirit, a pragmatic phase IIIb, randomised controlled study. Int J Clin Trials. 2023;10(2):156-65.
National Institute of Clinical Excellence (NICE). Inclisiran for treating primary hypercholesterolaemia or mixed dyslipidaemia: Technology appraisal guidance [TA733]. 2021. Available at: https://www.nice.org.uk/guidance/ta733. Accessed on 14 February 2022.
The AHSN Network. Lipid Management and Familial Hypercholesterolaemia. 2019. Available at: https://www.ahsnnetwork.com/about-academic-health-science-networks/national-programmes-priorities/lipid-management-and-fh. Accessed on 30 May 2022.
NHS Digital. Lipid management searches. 2022. Available at: https://digital.nhs.uk/services/lipid-management-searches. Accessed on 08 February 2022.
Pate A, Barrowman M, Webb D, Pimenta JM, Davis KJ, Williams R, et al. Study investigating the generalisability of a COPD trial based in primary care (Salford Lung Study) and the presence of a Hawthorne effect. BMJ Open Respir Res. 2018;5:e000339.
Office of National Statistics. Census Table KS102EW Age Structure. 2011. Available at: https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/datasets/2011censuskeystatisticsforlocalauthoritiesinenglandandwales. Accessed on 22 April 2022.
Office of National Statistics. Census Table KS201EW Ethnic Group. 2011. Available at: https://www.ons.gov.uk/search?q=2011+Census%2C+Table+KS201EW%2C+Ethnic+group%29. Accessed on 22 April 2022.
Quality Outcomes Framework. QOF Database. Greater Manchester Health & Social Care Partnership. 2021. Available at: https://www. gpcontract.co.uk/browse/QOP/21. Accessed on 13 May 2022.
