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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EThe primary objective of the Reassessment of Antiplatelet Therapy using an Individualized Strategy Based on Genetic Evaluation [RAPID GENE; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01184300\u0026amp;atom=%2Fspmdc%2F11%2F14%2F8.atom\u0022\u003ENCT01184300\u003C\/a\u003E] study was to evaluate the feasibility and test characteristics of a nurse-operated POC genetic test to determine CYP2C19*2 carrier status.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECoronary Artery Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Genomics\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENursing\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EPrevious studies suggest that \u003Cem\u003ECYP2C19\u003C\/em\u003E loss-of-function alleles affect clopidogrel metabolism and are associated with major adverse cardiac events (MACE) and stent thrombosis. \u003Cem\u003ECYP2C19\u003C\/em\u003E*2 accounts for 95% of \u003Cem\u003ECYP2C19\u003C\/em\u003E loss-of-function alleles and occurs in up to 25% of Caucasian populations and 40% of Asian populations.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003ECurrently, most genetic testing is done in central laboratories, with a turnaround time of 2 to 7 days. This delay has prevented the prospective evaluation of genetic testing in percutaneous coronary intervention (PCI) studies. The University of Ottawa Heart Institute, in collaboration with Spartan Biosciences, created the first point-of-care (POC) genetic test. After 1 hour, nurses were able to determine a patient\u0027s \u003Cem\u003ECYP2C19\u003C\/em\u003E*\u003Cem\u003E2\u003C\/em\u003E carrier status and whether the patient was heterozygous or homozygous by utilizing the new technology.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThe primary objective of the Reassessment of Antiplatelet Therapy using an Individualized Strategy Based on Genetic Evaluation (\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01184300\u0026amp;atom=%2Fspmdc%2F11%2F14%2F8.atom\u0022\u003ENCT01184300\u003C\/a\u003E; RAPID GENE) study, presented by Derek So, MD, University of Ottawa Heart Institute, Ottawa, Ontario, Canada, was to evaluate the feasibility and test characteristics of a nurse-operated POC genetic test to determine \u003Cem\u003ECYP2C19\u003C\/em\u003E*\u003Cem\u003E2\u003C\/em\u003E carrier status.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EPCI patients with non-ST elevation acute coronary syndrome (ACS) or stable coronary artery disease (CAD) were pretreated with a minimum of 600 mg clopidogrel. Following baseline platelet function testing, the patients were randomized 1:1 to rapid genotyping (RG; n=102) using the new POC technology or to no POC testing and standard therapy (ST; n=98) with clopidogrel 75 mg daily. In the RG group, \u003Cem\u003ECYP2C19\u003C\/em\u003E*\u003Cem\u003E2\u003C\/em\u003E carriers were treated with prasugrel 10 mg daily, and noncarriers were treated with clopidogrel 75 mg daily. At 1 week, all patients underwent platelet function testing and DNA sequencing. Patients in the ST arm also underwent POC rapid genotyping after 1 week.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThe primary endpoint was the proportion of \u003Cem\u003ECYP2C19\u003C\/em\u003E*\u003Cem\u003E2\u003C\/em\u003E carriers with a P\u003Csub\u003E2\u003C\/sub\u003EY12 reaction unit (PRU) \u0026gt;234 (consistent with high on-treatment platelet reactivity) after 1 week of dual antiplatelet therapy.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EIn the RG arm, POC genotyping identified 25.3% (n=23) of patients as \u003Cem\u003ECYP2C19\u003C\/em\u003E*\u003Cem\u003E2\u003C\/em\u003E carriers, with 20.9% heterozygous and 4.4% homozygous. In the ST group after 1 week, POC genotyping identified a similar proportion of patients as \u003Cem\u003ECYP2C19\u003C\/em\u003E*\u003Cem\u003E2\u003C\/em\u003E carriers (24.0%; n=23), with 20.8% heterozygous and 3.1% homozygous. Compared with direct DNA sequencing, POC genotyping had a sensitivity of 100%, specificity of 99.4%, and a conclusive rate of 93.6%.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EThe proportion of \u003Cem\u003ECYP2C19\u003C\/em\u003E*\u003Cem\u003E2\u003C\/em\u003E carriers with high on-treatment platelet reactivity (PRU \u0026gt;234) was significantly lower in the RG group (prasugrel-treated) compared with the ST group (clopidogrel-treated; 0% vs 30.4%; p=0.009). \u003Cem\u003ECYP2C19\u003C\/em\u003E*\u003Cem\u003E2\u003C\/em\u003E carriers who were treated with prasugrel as compared with clopidogrel had a significantly lower PRU at 7 days (75.6 vs 207.3 PRU; p\u0026lt;0.001) and greater platelet inhibition after 7 days (73.3 vs 27.0 PRU; p\u0026lt;0.001), demonstrating the superior antiplatelet efficacy of prasugrel in this population. No MACE occurred in either group at 7 and 30 days.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EPOC genetic testing at the bedside, performed by nurses, is feasible and can accurately identify \u003Cem\u003ECYP2C19\u003C\/em\u003E*\u003Cem\u003E2\u003C\/em\u003E carriers. This novel, rapid genetic test facilitates rapid personalization of antiplatelet therapy. Administration of prasugrel to \u003Cem\u003ECYP2C19\u003C\/em\u003E*\u003Cem\u003E2\u003C\/em\u003E carriers decreased the rate of high on-treatment platelet reactivity relative to standard therapy with clopidogrel. These findings represent the validation and proof-of-concept of the first POC genetic test in clinical medicine. The results of the RAPID GENE trial will hopefully lead to larger-scale studies that can establish the role of pharmacogenomic tailored antiplatelet therapy after PCI.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2011 MD Conference Express\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/11\/14\/8.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzmvzp\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}