CaRi-Heart for predicting cardiac risk in suspected coronary artery disease
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1 Recommendations
1.1 CaRi-Heart is not recommended for use while further evidence is generated. It should only be used in the context of research to predict cardiac risk in people with suspected coronary artery disease (CAD).
1.2 Further research is recommended (see the section on further research) on:
clinical outcomes for people with suspected CAD who had CaRi-Heart testing
how CaRi-Heart results affect clinical decision making compared with UK standard clinical practice
the costs to the NHS of using CaRi-Heart
how well CaRi-Heart predicts cardiac risk to validate it in a UK population; in particular, data should be generated in the following subgroups: 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
There is an unmet clinical need to more accurately identify people who are at increased risk of heart attack or cardiac death. CaRi-Heart assesses the extent of inflammation around the arteries, which a CTCA scan (part of the standard risk assessment) does not. Clinical evidence shows that CaRi-Heart improves cardiac risk prediction compared with using a model based on traditional clinical risk factors. So it could better identify people (with or without CAD) who have coronary inflammation, who may need further treatment to lower their cardiac risk. But how its results might improve outcomes of people with recent-onset chest pain is unclear. This is because CaRi-Heart provides more information than UK standard clinical practice (CTCA alongside clinical assessment of risk factors) so the treatments that would be offered based on a CaRi-Heart result are not clearly defined, and there is no data on clinical outcomes after a CaRi-Heart result. It is also 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 price, and no data was identified on the costs or resource use associated with implementing CaRi-Heart. Based on the number of people who could be offered it, the costs to the NHS, if it were implemented while evidence is generated to demonstrate its value, could be substantial.
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.
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