{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T22:49:46Z","timestamp":1790894986860,"version":"4.1.0"},"reference-count":200,"publisher":"National Institute for Health and Care Research","license":[{"start":{"date-parts":[[2024,9,1]],"date-time":"2024-09-01T00:00:00Z","timestamp":1725148800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["NIHR135620"],"award-info":[{"award-number":["NIHR135620"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journalslibrary.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"Background<\/jats:title>\nStroke or transient ischaemic attack patients are at increased risk of secondary vascular events. Antiplatelet medications, most commonly clopidogrel, are prescribed to reduce this risk. Factors including CYP2C19<\/jats:italic> genetic variants can hinder clopidogrel metabolism. Laboratory-based or point-of-care tests can detect these variants, enabling targeted treatment.<\/jats:p>\n<\/jats:sec>\nObjective<\/jats:title>\nTo assess the effectiveness of genetic testing to identify clopidogrel resistance in people with ischaemic stroke or transient ischaemic attack. Specific objectives:<\/jats:p>\n\nDo people tested for clopidogrel resistance, and treated accordingly, have a reduced risk of secondary vascular events?<\/jats:p><\/jats:list-item>\nDo people with loss-of-function alleles associated with clopidogrel resistance have a reduced risk of secondary vascular events if treated with alternative interventions compared to clopidogrel?<\/jats:p><\/jats:list-item>\nDo people with loss-of-function alleles associated with clopidogrel resistance have an increased risk of secondary vascular events when treated with clopidogrel?<\/jats:p><\/jats:list-item>\nWhat is the accuracy of point-of-care tests for detecting variants associated with clopidogrel resistance?<\/jats:p><\/jats:list-item>\nWhat is the technical performance and cost of CYP2C19<\/jats:italic> genetic tests?<\/jats:p><\/jats:list-item>\nIs genetic testing for clopidogrel resistance cost-effective compared with no testing?<\/jats:p><\/jats:list-item>\n<\/jats:list>\n<\/jats:sec>\nDesign<\/jats:title>\nSystematic review and economic model.<\/jats:p>\n<\/jats:sec>\nResults<\/jats:title>\nObjective 1: Two studies assessed secondary vascular events in patients tested for loss-of-function alleles and treated accordingly. They found a reduced risk, but confidence intervals were wide (hazard ratio 0.50, 95% confidence interval 0.09 to 2.74 and hazard ratio 0.53, 95% confidence interval 0.24 to 1.18).<\/jats:p>\nObjective 2: Seven randomised controlled trials compared clopidogrel with alternative treatment in people with genetic variants. Ticagrelor was associated with a lower risk of secondary vascular events than clopidogrel (summary hazard ratio 0.76, 95% confidence interval 0.65 to 0.90; two studies).<\/jats:p>\nObjective 3: Twenty-five studies compared outcomes in people with and without genetic variants treated with clopidogrel. People with genetic variants were at an increased risk of secondary vascular events (hazard ratio 1.72, 95% confidence interval 1.43 to 2.08; 18 studies). There was no difference in bleeding risk (hazard ratio 0.98, 95% confidence interval 0.68 to 1.40; five studies).<\/jats:p>\nObjective 4: Eleven studies evaluated Genomadix Cube accuracy; no studies evaluated Genedrive. Summary sensitivity and specificity against laboratory reference standards were both 100% (95% confidence interval 94% to 100% and 99% to 100%).<\/jats:p>\nObjective 5: Seventeen studies evaluated technical performance of point-of-care tests. Test failure rate ranged from 0.4% to 19% for Genomadix Cube. A survey of 8\/10 genomic laboratory hubs revealed variation in preferred technologies for testing, and cost per test ranging from \u00a315 to \u00a3250. Most laboratories expected test failure rate to be <\u20091%. Additional resources could enhance testing capacity and expedite turnaround times.<\/jats:p>\nObjective 6: Laboratory and point-of-care CYP2C19<\/jats:italic> testing strategies were cost-saving and increase quality-adjusted life-years compared with no testing. Both strategies gave similar costs, quality-adjusted life-years and expected net monetary benefit.<\/jats:p>\n<\/jats:sec>\nConclusions<\/jats:title>\nOur results suggest that CYP2C19<\/jats:italic> testing followed by tailored treatment is likely to be effective and cost-effective in both populations.<\/jats:p>\n<\/jats:sec>\nFuture work<\/jats:title>\n\nAccuracy and technical performance of Genedrive.<\/jats:p><\/jats:list-item>\nTest failure rate of Genomadix Cube in a National\u00a0Health\u00a0Service\u00a0setting.<\/jats:p><\/jats:list-item>\nValue of testing additional loss-of-function alleles.<\/jats:p><\/jats:list-item>\nAppropriateness of treatment dichotomy based on loss-of-function alleles.<\/jats:p><\/jats:list-item>\n<\/jats:list>\n<\/jats:sec>\nLimitations<\/jats:title>\n\nLack of data on Genedrive.<\/jats:p><\/jats:list-item>\nNo randomised \u2018test-and-treat\u2019 studies of dipyramidole plus aspirin.<\/jats:p><\/jats:list-item>\n<\/jats:list>\n<\/jats:sec>\nStudy registration<\/jats:title>\nThis study is registered as PROSPERO CRD42022357661.<\/jats:p>\n<\/jats:sec>\nFunding<\/jats:title>\nThis award was funded by the National Institute for Health and Care Research (NIHR) Evidence Synthesis programme (NIHR award ref: NIHR135620) and is published in full in Health Technology Assessment<\/jats:italic>; Vol. 28, No. 57. See the NIHR Funding and Awards website for further award information.<\/jats:p>\n<\/jats:sec>","DOI":"10.3310\/pwcb4016","type":"journal-article","created":{"date-parts":[[2024,9,13]],"date-time":"2024-09-13T13:23:54Z","timestamp":1726233834000},"page":"1-194","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":14,"title":["Clinical and cost-effectiveness of clopidogrel resistance genotype testing after ischaemic stroke or transient ischaemic attack: a systematic review and economic model"],"prefix":"10.3310","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-7006-0938","authenticated-orcid":true,"given":"Joe","family":"Carroll","sequence":"first","affiliation":[{"name":"Bristol TAG, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, 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