Advice
Expert comments
Expert comments
Comments on this technology were invited from clinical experts working in the field and relevant patient organisations. The comments received are individual opinions and do not represent NICE's view.
Experts were aware of Spartan CYP2C19 genotype testing but none of the experts had used this technology before.
Level of innovation
Two of the experts felt that Spartan RX is innovative and a novel approach to antiplatelet therapy decision making for patients presenting with acute coronary syndromes. One highlighted that current standard care in the NHS does not use any form of genetic testing to guide antiplatelet therapy. One expert felt it was a minor variation compared with standard care and that they had not yet found a clinical need to use this type of testing. An alternative assay used to detect CYP2C19 polymorphism was identified by 2 of the experts. One of these experts added that this alternative assay requires a blood sample for analysis.
Potential patient impact
Two experts said that the potential for personalised antiplatelet therapy by identifying patients who are unlikely to have a response to clopidogrel was a key benefit of the technology. The potential benefits of genotype-guided antiplatelet therapy that were identified by the experts include reduced bleeding, as well as reduced incidence of myocardial infarction, stent thrombosis and death. One expert said that improved clinical outcomes may be associated with reduced hospital visits and hospital-based investigations and treatment. Patients at high risk of bleeding, patients at high risk of future ischemic complications and patients at high risk of stent thrombosis were identified by some of the experts as those who would benefit most from Spartan RX testing. One of the experts noted that the benefits would be limited to patients with stable angina having coronary angioplasty with stent implantation who have had prior issues with clopidogrel efficacy or tolerability.
Potential system impact
Two experts noted that testing with Spartan RX has the potential to reduce morbidity and mortality and the subsequent costs associated with treating bleeding and ischemic complications. One expert felt that system benefits would be limited to patients with stable angina having coronary angioplasty with stent implantation who have had prior issues with clopidogrel efficacy or tolerability. All of the experts said that Spartan RX test would be an addition to standard care. Two experts felt that the technology could provide cost savings in the long term, whereas another expert felt that the technology would cost more than standard care and was unlikely to reduce the use of resources. Two experts noted that each trust would need to buy the machine and the test kits needed for each patient. One of these experts added that the resource impact will be minimal, but that the company would need to train clinical staff on how to use the assay and interpret results. The other expert said that adopting the technology would have no effect on primary care or care setting because the test is done in the catheter lab or cardiac care unit (CCU) at the time of percutaneous coronary intervention (PCI) and is unlikely to need additional staff. Potential barriers to adoption identified by experts were technology costs, as well as the niche role that 1 expert thought the test would play in a small group of patients.
General comments
The experts noted that the technology was not yet used in the NHS and none of the experts were aware of any centres using the test routinely. One expert said that test is relatively easy to undertake (buccal swap and automatic point-of-care device). One of the experts did not think the technology will play a major role managing acute coronary syndromes. But they thought it could have a role in around 5% of patients with stable coronary disease having PCI. One expert was concerned about the repeated sampling needed in a substantial number of patients because of inconclusive results. One expert felt that an adequately powered global randomised controlled trial would be needed to show improvement in all-cause mortality, cardiovascular mortality, stroke and myocardial infarction compared with standard care. Another expert highlighted that, given the regional differences in genotype frequency, data from UK-based studies would be useful. They also said that future studies that focus on high bleeding risk groups would be helpful.