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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.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\u003EApixaban, an oral factor Xa inhibitor, is noninferior to enoxaparin plus warfarin for the treatment of acute symptomatic proximal deep vein thrombosis and pulmonary embolism, and is associated with significantly less bleeding compared with conventional therapy. Administered in fixed doses, apixaban may simplify the treatment of acute venous thromboembolism. This article presents the results of the Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism [AMPLIFY; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00643201\u0026amp;atom=%2Fspmdc%2F13%2F13%2F11.atom\u0022\u003ENCT00643201\u003C\/a\u003E].\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EThrombophilia\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHematology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EThrombotic Disorders\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EThrombophilia\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHematology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EThrombotic Disorders\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHematology\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EApixaban, an oral factor Xa inhibitor, is noninferior to enoxaparin plus warfarin for the treatment of acute symptomatic proximal deep vein thrombosis (DVT) and pulmonary embolism (PE), and is associated with significantly less bleeding compared with conventional therapy. Administered in fixed doses, apixaban may simplify the treatment of acute venous thromboembolism (VTE). Giancarlo Agnelli, MD, University of Perugia, Perugia, Italy, presented the results of the Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism [AMPLIFY; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00643201\u0026amp;atom=%2Fspmdc%2F13%2F13%2F11.atom\u0022\u003ENCT00643201\u003C\/a\u003E].\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe purpose of this 6\u2013month, randomized, double-blind, noninferiority trial was to compare the efficacy and safety of apixaban (10 mg BID for 7 days, followed by 5 mg BID) with conventional anticoagulant therapy consisting of subcutaneous enoxaparin (1 mg\/kg BID) followed by warfarin (target INR 2 to 3). The study enrolled adults with acute symptomatic proximal DVT or PE. The criteria for noninferiority required that the upper limit of the 95% CIs be below prespecified margins for both the relative risk (\u0026lt;1.8) and the absolute risk difference (\u0026lt;3.5%). The diagnosis at study entry, the extent of initial DVT or PE, and all suspected outcomes were adjudicated by an independent committee, whose members were unaware of study group assignments.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThe primary efficacy outcome was symptomatic recurrent VTE or VTE-related death. Other outcomes included recurrent symptomatic VTE or cardiovascular-related death, and recurrent symptomatic VTE or all-cause death. The primary safety outcome was adjudicated major bleeding. The secondary safety outcome was the composite of major bleeding and clinically relevant nonmajor bleeding.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EPatients (n=5400; mean age, 57 years; 58% men) were enrolled at 358 centers in 28 countries and assigned to receive either apixaban (n=2691) or conventional therapy (n=2704). Approximately 65% of patients entered the study with DVT, 25% with PE, and \u22129% with DVT plus PE. VTE was unprovoked in 90% of patients. Most (75%) patients had a femoral or more proximal DVT, while 38% had extensive PE that included \u22652 lobes with \u226550% of the vasculature for each lobe affected.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EAfter 6 months, 57 (2.3%) of the patients receiving apixaban experienced a first recurrent VTE or VTE-related death compared with 71 (2.7%) receiving conventional therapy. Apixaban was noninferior to conventional treatment (relative risk [RR], 0.84; 95% CI, 0.60 to 1.18; p\u0026lt;0.0001 for noninferiority; \u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E). Similar results were seen with the secondary outcomes.\u003C\/p\u003E\u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/13645\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/13645\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/13645\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\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-7\u0022 class=\u0022first-child\u0022\u003EEfficacy Outcomes\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-8\u0022\u003EDays to first recurrent VTE or VTE-related death, the majority of which occurred in the first 30 days, were similar in the two treatment groups. The percentage of time in therapeutic range was 60.9% for warfarin-treated patients.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EIn the apixaban group, 15 (0.6%) patients had major bleeding versus 49 (1.8%) in the conventionally treated group (RR, 0.31; 95% CI, 0.17 to 0.55; p\u0026lt;0.0001 superiority for apixaban). Clinically relevant nonmajor bleeding and major or clinically relevant nonmajor bleeding occurred in 3.9% and 4.3% of patients in the apixaban group and 8.0% and 9.7% of patients in the conventional group, respectively.\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003EApixaban administered in a simple, fixed-dose regimen, may be an option for the extended treatment of VTE. It is noninferior to conventional therapy for preventing recurrent VTE, with similar efficacy in patients with DVT and PE, and clinically important and statistically significant reduction in major bleeding of 69%.\u003C\/p\u003E\u003Cp id=\u0022p-11\u0022\u003EThis study was simultaneously published [Agnelli G et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2013].\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2013 MD Conference Express\u00ae\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\/13\/13\/11.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?nznoxe\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_tables.js?nznoxe\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}