1 Recommendations
1.1 CaRi‑Heart is not recommended for use in the NHS while further evidence is generated. It should only be used in research to predict cardiac risk in people with suspected coronary artery disease (CAD), while treatment strategies to reduce coronary inflammation and cardiac death are identified.
1.2 Further research is recommended (see the section on further research) on:
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how clinical outcomes might change for people with suspected CAD who have had CaRi‑Heart testing and appropriate treatment
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how CaRi‑Heart results affect clinical decision making compared with UK standard clinical practice
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the costs to the NHS of using CaRi‑Heart
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how well CaRi‑Heart predicts cardiac risk to validate it in a UK population; in particular, data should be generated in the following groups: women, people from different ethnic backgrounds, and people who do not have CAD identified on CT coronary angiography (CTCA).
Why the committee made these recommendations
CaRi‑Heart assesses the extent of inflammation around the arteries, which a CTCA scan (part of the standard risk assessment) does not. So, it could better identify people (with or without CAD) who have coronary inflammation, and who may need further treatment to lower their cardiac risk. But it is unclear what treatments would be offered based on a CaRi‑Heart result because they are not clearly defined. There is also no data on how clinical outcomes might change after a CaRi‑Heart result. Without a clear treatment strategy, it is uncertain whether CaRi‑Heart might improve outcomes for people with suspected coronary artery disease. So, its value is unclear.
Clinical evidence shows that CaRi‑Heart improves cardiac risk prediction compared with using a model based on traditional clinical risk factors. But it is uncertain how CaRi‑Heart would perform compared with UK standard clinical practice.
CaRi‑Heart's cost to the NHS is unknown because the company has not yet specified the NHS price, and no data was identified on the costs or resource use associated with implementing CaRi‑Heart. Based on the list price and the number of people who could be offered it, the costs to the NHS could be substantial if it were implemented while evidence is generated to demonstrate its value.
Because of the uncertainty around its benefits and costs, CaRi‑Heart cannot be recommended for routine use in the NHS. But it might more accurately identify people at risk of heart attack or cardiac death than the standard risk assessment alone. So further research is recommended to see if CaRi‑Heart testing can lead to effective treatment strategies to improve outcomes for people with cardiac risk.