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{\u0022basePath\u0022:\u0022\\\/\u0022,\u0022pathPrefix\u0022:\u0022\u0022,\u0022highwire\u0022:{\u0022markup\u0022:[{\u0022requested\u0022:\u0022full-text\u0022,\u0022variant\u0022:\u0022full-text\u0022,\u0022view\u0022:\u0022full\u0022,\u0022pisa\u0022:\u0022spmdc;6\\\/1\\\/14\u0022},{\u0022requested\u0022:\u0022long\u0022,\u0022variant\u0022:\u0022full-text\u0022,\u0022view\u0022:\u0022full\u0022,\u0022pisa\u0022:\u0022spmdc;6\\\/1\\\/14\u0022}],\u0022ac\u0022:{\u0022spmdc;6\\\/1\\\/14\u0022:{\u0022access\u0022:{\u0022reprint\u0022:true,\u0022full\u0022:true},\u0022pisa_id\u0022:\u0022spmdc;6\\\/1\\\/14\u0022,\u0022atom_uri\u0022:\u0022\u0022,\u0022jcode\u0022:\u0022spmdc\u0022}}},\u0022googleanalytics\u0022:{\u0022trackOutbound\u0022:1,\u0022trackMailto\u0022:1,\u0022trackDownload\u0022:1,\u0022trackDownloadExtensions\u0022:\u00227z|aac|arc|arj|asf|asx|avi|bin|csv|doc(x|m)?|dot(x|m)?|exe|flv|gif|gz|gzip|hqx|jar|jpe?g|js|mp(2|3|4|e?g)|mov(ie)?|msi|msp|pdf|phps|png|ppt(x|m)?|pot(x|m)?|pps(x|m)?|ppam|sld(x|m)?|thmx|qtm?|ra(m|r)?|sea|sit|tar|tgz|torrent|txt|wav|wma|wmv|wpd|xls(x|m|b)?|xlt(x|m)|xlam|xml|z|zip\u0022,\u0022trackUrlFragments\u0022:1},\u0022ajaxPageState\u0022:{\u0022js\u0022:{\u0022sites\\\/all\\\/libraries\\\/cluetip\\\/jquery.cluetip.js\u0022:1,\u0022sites\\\/all\\\/libraries\\\/cluetip\\\/lib\\\/jquery.hoverIntent.js\u0022:1,\u0022sites\\\/all\\\/libraries\\\/cluetip\\\/lib\\\/jquery.bgiframe.min.js\u0022:1,\u0022sites\\\/all\\\/modules\\\/highwire\\\/highwire\\\/plugins\\\/highwire_markup_process\\\/js\\\/highwire_at_symbol.js\u0022:1,\u0022sites\\\/all\\\/modules\\\/highwire\\\/highwire\\\/plugins\\\/highwire_markup_process\\\/js\\\/highwire_article_reference_popup.js\u0022:1,\u0022sites\\\/all\\\/modules\\\/contrib\\\/google_analytics\\\/googleanalytics.js\u0022:1,\u00220\u0022:1}}});\n\/\/--\u003E\u003C!]]\u003E\n\u003C\/script\u003E\n\u003Clink 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 central issue examined by the Acute Catheterization and Urgent Intervention Triage Strategy\n(ACUITY) Trial, according to principal investigator Gregg W. Stone, MD, Columbia University Medical\nCenter and the Cardiovascular Research Foundation, was \u201chow best to anticoagulate patients\nwith acute coronary syndromes (ACS).\u201d\u003C\/p\u003E\n            \u003Cp id=\u0022p-2\u0022\u003EACUITY was a two part study; a main study evaluating optimum anticoagulation strategies, with a\nsub-study (ACUITY-TIMING) that looked at timing of anticoagulation therapy.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Eclinical trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ecoronary artery disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ethrombotic\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \n         \u003Cp id=\u0022p-3\u0022\u003EThe central issue examined by the Acute Catheterization and Urgent Intervention Triage Strategy\n(ACUITY) Trial, according to principal investigator Gregg W. Stone, MD, Columbia University Medical\nCenter and the Cardiovascular Research Foundation, was \u201chow best to anticoagulate patients\nwith acute coronary syndromes (ACS).\u201d\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003EACUITY was a two part study; a main study evaluating optimum anticoagulation strategies, with a\nsub-study (ACUITY-TIMING) that looked at timing of anticoagulation therapy.\u003C\/p\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EThe main ACUITY study asked 2 key questions:\u003C\/p\u003E\n         \u003Cp id=\u0022p-6\u0022\u003EIs heparin (unfractionated heparin [UH] or enoxaparin) or bivalirudin the more effective\nanticoagulant in non-ST elevation unstable coronary syndrome?\u003C\/p\u003E\n         \u003Cp id=\u0022p-7\u0022\u003EWill bivalirudin plus a glycoprotein IIb\/IIIa inhibitor (GPI) be more effective than enoxaparin\nand a GPI in preventing ischemic complications in patients with unstable angina\u2014while\nslightly decreasing or at least not increasing major bleeding?\u003C\/p\u003E\n         \u003Cp id=\u0022p-8\u0022\u003EIn ACUITY-Timing the question of when to initiate anticoagulation was addressed. Is it better to\nstart GPIs \u201cupstream,\u201d at the time of patient presentation, or initiate GPI therapy\nselectively in patients triaged to PCI after angiography?\u003C\/p\u003E\n         \u003Cp id=\u0022p-9\u0022\u003EDr. Stone noted that advocates of \u201cupstream\u201d therapy contend that some patients\nexperience MI and death while awaiting revascularization\u2014an outcome that a GPI might prevent.\nThose who support waiting to initiate therapy \u201cwould maintain that MI or death doesn\u0027t\nhappen very often,\u201d Dr. Stone observed, \u201cand that major bleeding might occur while on\nanticoagulants.\u201d\u003C\/p\u003E\n         \u003Cp id=\u0022p-10\u0022\u003EACUITY enrolled more than 13,000 patients with a median age of 63 years, 30% of them\nwomen. Patients were randomized to three study arms: (1) UH or enoxaparin plus GPI; (2) bivalirudin\nplus GPI, or (3) bivalirudin alone. (In the bivalirudin alone arm, GPIs could be used when needed\nfor \u201cbailout\u201d if sub-optimal clinical results were encountered.) The study\u0027s\nmean follow-up period was 1 year.\u003C\/p\u003E\n         \u003Cp id=\u0022p-11\u0022\u003EAspirin was also administered, and clopidogrel was recommended but not mandated.\u003C\/p\u003E\n         \u003Cp id=\u0022p-12\u0022\u003EACUITY-Timing data was generated by a second randomization. ACUITY patients (n=9200) with\nmoderate to high risk ACS randomized to either the heparin or bivalirudin arms were subsequently\nrandomized to two further arms: (1) upstream GPI vs. (2) no upstream GPI with GPI used selectively\nin patients triaged to PCI.\u003C\/p\u003E\n         \u003Cp id=\u0022p-13\u0022\u003EACUITY\u0027s primary endpoints were: (1) A composite of death, MI, unplanned revascularization\nfor ischemia, and major bleeding at 30 days; (2) a composite of death, MI, and unplanned\nrevascularization at 30 days, and (3) major bleeding at 30 days\u003C\/p\u003E\n         \u003Cp id=\u0022p-14\u0022\u003EAmong patients with acute coronary syndromes, treatment with bivalirudin alone was associated\nwith reduction in MI, unplanned revascularization, major bleeding, or mortality at 30 days, as\ncompared with UH\/enoxaparin plus GPI, driven primarily by a reduction in bleeding. Additionally, Dr.\nStone noted that \u201cbivalirudin plus a GPI and bivalirudin alone were not inferior to heparin\nplus a GPI.\u201d\u003C\/p\u003E\n         \u003Cp id=\u0022p-15\u0022\u003EFor the ACUITY-Timing sub-study, delayed GPIs in patients with ACS was associated with less major\nbleeding at 30 days compared with upstream GPI administration. The difference between rates of major\nbleeding was statistically significant\u20146.1% for upstream GPI vs. 4.9% for\ndeferred GPI (p=0.009). Ischemic endpoints did not meet non-inferiority criteria (7.1%\nfor upstream vs 7.9% for delayed). No difference in mortality was seen (1.3% upstream\nvs. 1.5% delayed) or MI (4.9% vs 5.0%), but unplanned revascularization for\nischemia was slightly lower in the upstream group (2.1% vs 2.8%, p=0.03 for\nsuperiority). Among patients who went on to PCI (n=5,170), the composite ischemic endpoint\nwas significantly lower in the upstream therapy group (8.0% vs 9.5%,\np=0.05).\u003C\/p\u003E\n         \u003Cp id=\u0022p-16\u0022\u003EAmong ACS patients, upstream GPI therapy was non-inferior for the net clinical benefit endpoint,\ncompared with delayed GPI administration\u2014but did not meet the criteria for non-inferiority\nfor the ischemic endpoint.\u003C\/p\u003E\n         \u003Cp id=\u0022p-17\u0022\u003EOverall, ACUITY suggests that bivalirudin monotherapy reduces bleeding without a significant\nincrease in events, compared with heparin + GPI. Meanwhile, ACUITY-Timing suggests that while\nupstream GPI is associated with fewer ischemic events, there was no difference in net clinical\noutcome between the two strategies.\u003C\/p\u003E\n         \u003Cp id=\u0022p-18\u0022\u003E\u201cThe bottom line is that bivalirudin monotherapy is as good as UFH or enoxaparin plus a\nIIb\/IIIa blocker but with far less bleeding,\u201d said Dr. Stone. \u201cBivalirudin monotherapy\nwill facilitate care tremendously.\u201d\u003C\/p\u003E\n         \u003Cp id=\u0022p-19\u0022\u003EHowever, session moderator Matthew Wolff, MD, Chief, Cardiovascular Medicine, University of\nWisconsin, noted that ACUITY was a complex trial. \u201cResults here become difficult to\ninterpret,\u201d he said. \u201cIn ACUITY Timing, for example, only five hours separated the\nupstream and delayed use of GPI, which is not enough for meaningful comparison.\u201d\u003C\/p\u003E\n         \u003Cp id=\u0022p-20\u0022\u003EDr. Wolff indicated that seeing all the data will be important. \u201cOnce the data is\npublished we can assess various questions and caveats on dosages and timing this study\nraises.\u201d\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2006 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\/6\/1\/14.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?nzm6ap\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}