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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\u003EResults from the Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary Syndrome-Thrombolysis In Myocardial Infarction 51 [ATLAS ACS 2-TIMI 51; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00809965\u0026amp;atom=%2Fspmdc%2F11%2F15%2F10.atom\u0022\u003ENCT00809965\u003C\/a\u003E] Trial showed that rivaroxaban significantly reduced the risk of cardiovascular death, myocardial infarction, and stroke in acute coronary syndrome patients.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EMyocardial Infarction\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EThrombotic Disorders Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EThe emergence of a series of novel oral anticoagulants with pharmacological advantages, relative to traditional vitamin-K antagonists, has allowed renewed investigation into the role of anticoagulation of various intensities for patients with acute coronary syndromes (ACS).\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EC. Michael Gibson, MD, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA, reported results from the Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary Syndrome-Thrombolysis In Myocardial Infarction 51 (ATLAS ACS 2-TIMI 51) Trial [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00809965\u0026amp;atom=%2Fspmdc%2F11%2F15%2F10.atom\u0022\u003ENCT00809965\u003C\/a\u003E], which showed that rivaroxaban, an oral direct factor Xa inhibitor, significantly reduced the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in ACS patients. Rivaroxaban increased the risk of major bleeding and intracranial hemorrhage (ICH) but not the risk of fatal bleeding.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EIn this double-blind, placebo-controlled trial, 15,526 patients with a recent ACS (STEMI, NSTEMI, unstable angina; stabilized 1 to 7 days postindex event) were randomly assigned to receive twice-daily doses of either 2.5 mg (n=5174) or 5 mg (n=5176) rivaroxaban or placebo (n=5176) for a mean of 13 months, in addition to standard ACS antiplatelet therapies. Patients were excluded if they had an increased bleeding risk, current warfarin use, prior ICH, or prior ischemic stroke if on both aspirin (ASA) and a thienopyridine. The primary efficacy endpoint was a composite of death from CV causes, MI, or stroke (ischemic, hemorrhagic, or uncertain origin). TIMI major bleeding that was not associated with coronary artery bypass grafting (CABG) was the major safety assessment. The primary method of analysis was a log-rank test, stratified by thienopyridine use in the modified intent-to-treat (mITT) population with confirmation in an ITT analysis. Study endpoints were expressed as Kaplan-Meier estimates through 24 months.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EParticipants had a mean age of 62 years; 75% were male; and 32% were diabetic. Approximately 75% of the participants had an MI (50% STEMI; 26% NSTEMI). Ninety-three percent of the participants were treated with dual antiplatelet therapy at baseline, with a mean duration of treatment with thienopyridine of 13.3 months. The median time from the index event to randomization was 4.7 days.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003ERivaroxaban (composite of both doses) significantly reduced the primary efficacy endpoint, as compared with placebo (8.9% vs 10.7%; HR, 0.84; 95% CI, 0.74 to 0.96; p=0.008 mITT; p=0.002 ITT), with significant reductions for both the twice-daily 2.5-mg (9.1% vs 10.7%; p=0.02) and the twice-daily 5-mg dose (8.8% vs 10.7%; p=0.03). The absolute risk reduction was 1.8%, with a number needed to treat for 2 years of 56. The twice-daily 2.5-mg dose reduced the rate of death from CV causes (2.7% vs 4.1%; p=0.002) and from any cause (2.9% vs 4.5%; p=0.002). Overall results were consistent, regardless of whether patients were on ASA plus a thienopyridine or ASA only (p-interaction 0.94). A survival benefit for CV death was not seen with the twice-daily 5-mg dose. Overall, rivaroxaban reduced the risk for composite CV death, MI, or stroke by 16% and reduced stent thrombosis by 31%.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EThe primary safety endpoint of non-CABG TIMI major bleeding was increased with rivaroxaban (2.1% vs 0.6%; HR, 3.96; 95% CI, 2.46 to 6.38; p\u0026lt;0.001), as were TIMI minor bleeding (p=0.003) and ICH (p=0.009). Bleeding was dose-dependent, with higher rates in the 5-mg rivaroxaban group, including non-CABG TIMI major bleeding (1.8% for the 2.5 mg group and 2.4% in the 5 mg group vs 0.6% for placebo patients; both p\u0026lt;0.001). However, there was no excess of fatal ICH or fatal bleeding and no evidence of hepatotoxicity or posttreatment rebound ischemic events with rivaroxaban.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EOverall, these results demonstrate that low-level anticoagulation is effective for reducing recurrent events in patients with ACS, including mortality. One of the most important findings of this study is the importance of appropriate dosing for anticoagulation in post-ACS patients. Traditional intensity anticoagulation using a different oral Xa inhibitor, apixaban, was shown to be harmful in patients with ACS [Alexander JH et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2011]. The current trial shows efficacy at doses of rivaroxaban that are significantly lower than that used for atrial fibrillation (20 mg daily), with the greatest efficacy at the lowest dose of 2.5 mg twice daily. These results will need to be integrated with those of other recent trials to determine the optimal overall combination of antithrombotic therapy for patients with ACS.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2011 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section ref-list\u0022 id=\u0022ref-list-1\u0022\u003E\u003Ch2 class=\u0022\u0022\u003EFurther Reading\u003C\/h2\u003E\u003Col class=\u0022cit-list ref-use-labels\u0022\u003E\u003Cli\u003E\u003Cspan class=\u0022ref-label ref-label-empty\u0022\u003E\u003C\/span\u003E\n            \u003Cdiv class=\u0022cit ref-cit ref-journal no-rev-xref\u0022 id=\u0022cit-11.15.10.1\u0022\u003E\u003Cdiv class=\u0022cit-metadata\u0022\u003E\u003Col class=\u0022cit-auth-list\u0022\u003E\u003Cli\u003E\u003Cspan class=\u0022cit-auth\u0022\u003E\u003Cspan class=\u0022cit-name-surname\u0022\u003EMega\u003C\/span\u003E  \u003Cspan class=\u0022cit-name-given-names\u0022\u003EJL\u003C\/span\u003E\u003C\/span\u003E, \u003C\/li\u003E\u003Cli\u003E\u003Cspan class=\u0022cit-etal\u0022\u003Eet al.\u003C\/span\u003E\u003C\/li\u003E\u003C\/ol\u003E\u003Ccite\u003E \n               \u003Cabbr class=\u0022cit-jnl-abbrev\u0022\u003EN Engl J Med\u003C\/abbr\u003E \n               \u003Cspan class=\u0022cit-pub-date\u0022\u003E2011\u003C\/span\u003E.\u003C\/cite\u003E\u003C\/div\u003E\u003Cdiv class=\u0022cit-extra\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003C\/li\u003E\u003C\/ol\u003E\u003C\/div\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\/15\/10.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?nzmv41\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}