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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\u003EDoubling the dose of clopidogrel in patients with high residual platelet activity after percutaneous intervention has no significant effect on cardiovascular outcomes, according to the neutral results of the Gauging Responsiveness with A VerifyNow Assay\u2014Impact on Thrombosis And Safety [GRAVITAS; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00645918\u0026amp;atom=%2Fspmdc%2F10%2F10%2F19.atom\u0022\u003ENCT00645918\u003C\/a\u003E] trial.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EThrombotic Disorders\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EDoubling the dose of clopidogrel in patients with high residual platelet activity after percutaneous intervention (PCI) has no significant effect on cardiovascular (CV) outcomes. The neutral results of the Gauging Responsiveness with A VerifyNow Assay\u2014Impact on Thrombosis And Safety (GRAVITAS; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00645918\u0026amp;atom=%2Fspmdc%2F10%2F10%2F19.atom\u0022\u003ENCT00645918\u003C\/a\u003E) trial were presented by Matthew Price, MD, Scripps Clinic, La Jolla, California, USA.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe trial was designed to test the hypothesis that high-dose clopidogrel for 6 months would be superior to standard-dose clopidogrel in preventing adverse CV events in patients with high residual platelet reactivity after PCI. At least 7 studies, involving more than 3000 patients, have found that high residual (on-clopidogrel) platelet reactivity, as measured by the VerifyNow P2Y12 test, is associated with poor clinical outcomes after PCI [Price MJ et al. \u003Cem\u003EEur Heart J\u003C\/em\u003E 2008; Campo G et al. \u003Cem\u003EJ Am Coll Cardiol\u003C\/em\u003E 2010; Marcucci R et al. \u003Cem\u003ECirculation\u003C\/em\u003E 2009; Mangiacapra F et al. \u003Cem\u003EJ Am Coll Cardiol Intv\u003C\/em\u003E 2010; Patti G et al. \u003Cem\u003EJ Am Coll Cardiol\u003C\/em\u003E 2008; Migliorini A et al. \u003Cem\u003ECirculation\u003C\/em\u003E 2009; Bonello L et al. \u003Cem\u003EJ Am Coll Cardiol\u003C\/em\u003E 2010].\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EWhile some clinicians have already begun to treat patients with residual platelet reactivity with higher doses (\u0026gt;300-mg load, \u0026gt;75-mg daily maintenance) of clopidogrel, this was the first large, randomized, clinical trial to test a treatment strategy in such a patient population.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EThe trial involved 5429 subjects who received the standard clopidogrel regimen around the time of the PCI procedure. Their platelet function was evaluated with the VerifyNow P2Y12 test 12 to 24 hours after PCI. Of them, 2214 (41%) had high residual platelet reactivity (platelet reactivity units [PRU] \u0026gt;230) and were randomized to continue on the 75-mg standard clopidogrel dose or to receive another 600-mg loading dose and a higher maintenance dose of 150 mg daily. Follow-up VerifyNow assays, the results of which were not available to the treating physician, were performed at 30 days and 6 months to assess the effect of the intervention on platelet reactivity. All participants also received daily low-dose aspirin.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThe primary efficacy endpoint was CV death, nonfatal myocardial infarction (MI), or stent thrombosis at 6 months. The key safety endpoint was moderate or severe bleeding at 6 months.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EMost enrolled patients were at relatively low risk at baseline, with 84% having stable coronary artery disease or low-risk unstable angina. Results showed no significant differences between the 6-month rate of CV death, MI, or stent thrombosis, which was 2.3% for both groups (HR, 1.01; 95% CI, 0.58 to 1.76; p=0.98; \u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). Rates of bleeding, whether moderate or severe, were also similar in both groups (1.4% vs 2.3%, high dose and standard dose respectively; p=0.10).\u003C\/p\u003E\u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/10\/10\/19\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Primary Endpoint: CV Death, MI, Stent Thrombosis.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-367359425\u0022 data-figure-caption=\u0022Primary Endpoint: CV Death, MI, Stent Thrombosis.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/10\/10\/19\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/10\/10\/19\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/10\/10\/19\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/11376\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-8\u0022 class=\u0022first-child\u0022\u003EPrimary Endpoint: CV Death, MI, Stent Thrombosis.\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EReproduced with permission from M. Price, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-9\u0022\u003EPersistently high PRU levels (\u0026gt; 230) were significantly more common in the standard-dose group at 30 days (62% vs 40%; p\u0026lt;0.001), although achieving a lower PRU with higher-dose clopidogrel did not translate into improved clinical outcomes. One possible explanation is that the magnitude of the effect on platelet reactivity was not sufficient to demonstrate a clinically significant difference between these two dosing strategies of clopidogrel.\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003EDr. Price noted that high-dose clopidogrel was safe and that future trials should investigate more potent antiplatelet agents, focus on different populations, and test different treatment strategies\u2014eg, treating to a specific PRU target rather than basing treatment upon a single post-PCI assessment of platelet function.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2010 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\/10\/10\/19.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_figures.js?nzmn71\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzmn71\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}