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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 Randomized Evaluation of Long-Term Anticoagulant Therapy [RE-LY] trial showed that the oral direct thrombin inhibitor dabigatran is a safe and effective alternative to warfarin for the prevention of stroke in patients with atrial fibrillation.\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\u003EArrhythmias\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECerebrovascular Disease\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EResults from the RE-LY (Randomized Evaluation of Long-Term Anticoagulant Therapy) trial, presented by Professor Stuart Connolly, MD, McMaster University, Hamilton, Ontario, Canada, at the European Society of Cardiology Meeting in Barcelona, Spain, show that the oral direct thrombin inhibitor dabigatran is a safe and effective alternative to warfarin for the prevention of stroke in patients with atrial fibrillation (AF).\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003ERE-LY (\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00262600\u0026amp;atom=%2Fspmdc%2F9%2F4%2F17.atom\u0022\u003ENCT00262600\u003C\/a\u003E) was a phase 3, multicenter, multinational, noninferiority trial that was conducted to compare the efficacy and safety of two different doses of dabigatran with warfarin therapy. The study enrolled 18, 113 subjects (mean age 71 years; 64% men; 50% vitamin K antagonist experienced; mean CHADS\u003Csub\u003E2\u003C\/sub\u003E score 2.1) with electrocardiography-documented nonvalvular AF and at least one of the following: previous stroke or transient ischemic attack, left ventricular ejection fraction \u0026lt;40%, New York Heart Association class \u2265II within 6 months before screening, and age \u226575 years (65 to 74 years for subjects with diabetes, hypertension, or coronary artery disease). Subjects were randomly assigned to receive dabigatran 150 mg (n=6076) or 110 mg (n=6015) twice daily in a blinded fashion or open-label, adjusted-dose warfarin (n=6022). Median follow-up was 2 years and complete in 99.9% (20 subjects lost to follow-up). The primary efficacy outcome was hemorrhagic\/nonhemorrhagic stroke or systemic embolism, and the primary safety outcome was major hemorrhage.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EDabigatran 150 mg twice daily was superior to warfarin in reducing the primary efficacy endpoint (134 subjects; 1.11% per year versus 199 subjects; 1.69% per year; RR, 0.66; 95% CI, 0.53 to 0.82; p\u0026lt;0.001). The risk of major bleeding was similar (3.11% versus 3.36% per year in the dabigatran 150 mg and warfarin groups, respectively; RR, 0.93; 95% CI, 0.81 to 1.07; p=0.31). Meanwhile, dabigatran 110 mg twice daily achieved a similar rate of the primary efficacy endpoint compared with warfarin (182 subjects; 1.53% per year versus 199 subjects; 1.69% per year; RR, 0.91; 95% CI, 0.74 to 1.11; p=0.34; \u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E), meeting the criteria for noninferiority (p\u0026lt;0.001 for the prespecified noninferiority margin of 1.46), while the rate of major bleeding was significantly lower (2.71% vs 3.36% per year; RR, 0.80; 95% CI, 0.69 to 0.93; p=0.003). The rate of hemorrhagic stroke was significantly (p\u0026lt;0.001) lower with both doses of dabigatran (0.12% and 0.10% per year dabigatran 110 mg and 150 mg, respectively) versus warfarin (0.38% per year).\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\/9\/4\/17\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Cumulative Hazard Rates for the Primary Outcome of Stroke or Systemic Embolism, According to Treatment Group.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1886311783\u0022 data-figure-caption=\u0022Cumulative Hazard Rates for the Primary Outcome of Stroke or Systemic Embolism, According to Treatment Group.\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\/9\/4\/17\/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\/9\/4\/17\/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\/9\/4\/17\/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\/11354\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-5\u0022 class=\u0022first-child\u0022\u003ECumulative Hazard Rates for the Primary Outcome of Stroke or Systemic Embolism, According to Treatment Group.\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003ECopyright \u00a9 2009 Massachusetts Medical Society. All rights reserved.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-6\u0022\u003EOverall, the mean percentage of time in the therapeutic range for subjects who were randomized to warfarin was 64%. At 2 years, study drug was discontinued in 21% of those who were randomized to dabigatran compared with 16.6% in those who were randomized to open-label warfarin. Adverse events were similar between groups except for dyspepsia, which was significantly more common with dabigatran (707 subjects [11.8%] and 688 subjects [11.3%] in the 110-mg and 150-mg dabigatran groups, respectively, versus 348 subjects [5.8%] in the warfarin group; both p\u0026lt;0.001 compared with warfarin). Importantly, there was no significant difference in rates of abnormal liver function tests between groups, as had been observed with a prior oral direct thrombin inhibitor (ximelagatran).\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EThe net clinical benefit (a composite of stroke, systemic embolism, pulmonary embolism, myocardial infarction, death, or major bleeding) was significantly lower with the 150-mg dose of dabigatran compared with warfarin (RR, 0.91; 95% CI, 0.82 to 1.00; p=0.04) but was not different between the two doses of dabigatran (RR, 0.98; 95% CI, 0.89 to 1.08; p=0.66) or between the 110-mg dose of dabigatran and warfarin (RR, 0.92; 95% CI, 0.84 to 1.02; p=0.10).\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2009 MD Conference Express\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-9.4.17.1\u0022 data-doi=\u002210.1016\/j.ahj.2009.02.005\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\u003EEzekowitz\u003C\/span\u003E  \u003Cspan class=\u0022cit-name-given-names\u0022\u003EMD\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. \u003Cabbr class=\u0022cit-jnl-abbrev\u0022\u003EAm Heart J\u003C\/abbr\u003E \n               \u003Cspan class=\u0022cit-pub-date\u0022\u003E2009\u003C\/span\u003E;\u003Cspan class=\u0022cit-vol\u0022\u003E157\u003C\/span\u003E:\u003Cspan class=\u0022cit-fpage\u0022\u003E805\u003C\/span\u003E\u2013\u003Cspan class=\u0022cit-lpage\u0022\u003E810\u003C\/span\u003E\n            \u003C\/cite\u003E\u003C\/div\u003E\u003Cdiv class=\u0022cit-extra\u0022\u003E\u003Ca href=\u0022{openurl}?query=rft.jtitle%253DAm%2BHeart%2BJ%26rft.volume%253D157%26rft.spage%253D805%26rft_id%253Dinfo%253Adoi%252F10.1016%252Fj.ahj.2009.02.005%26rft_id%253Dinfo%253Apmid%252F19376304%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx\u0022 class=\u0022cit-ref-sprinkles cit-ref-sprinkles-openurl cit-ref-sprinkles-open-url\u0022\u003E\u003Cspan\u003EOpenUrl\u003C\/span\u003E\u003C\/a\u003E\u003Ca href=\u0022\/lookup\/external-ref?access_num=10.1016\/j.ahj.2009.02.005\u0026amp;link_type=DOI\u0022 class=\u0022cit-ref-sprinkles cit-ref-sprinkles-doi cit-ref-sprinkles-crossref\u0022\u003E\u003Cspan\u003ECrossRef\u003C\/span\u003E\u003C\/a\u003E\u003Ca href=\u0022\/lookup\/external-ref?access_num=19376304\u0026amp;link_type=MED\u0026amp;atom=%2Fspmdc%2F9%2F4%2F17.atom\u0022 class=\u0022cit-ref-sprinkles cit-ref-sprinkles-medline\u0022\u003E\u003Cspan\u003EMedline\u003C\/span\u003E\u003C\/a\u003E\u003Ca href=\u0022\/lookup\/external-ref?access_num=000265987800010\u0026amp;link_type=ISI\u0022 class=\u0022cit-ref-sprinkles cit-ref-sprinkles-newisilink cit-ref-sprinkles-webofscience\u0022\u003E\u003Cspan\u003EWeb of Science\u003C\/span\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003C\/li\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-9.4.17.2\u0022\u003E\u003Cdiv class=\u0022cit-metadata\u0022\u003E\u003Col class=\u0022duplicate\u0022\u003E\u003Cli\u003E\u003Cspan class=\u0022cit-auth\u0022\u003E\u003Cspan class=\u0022cit-name-surname\u0022\u003EGage\u003C\/span\u003E  \u003Cspan class=\u0022cit-name-given-names\u0022\u003EB.\u003C\/span\u003E\u003C\/span\u003E\u003C\/li\u003E\u003C\/ol\u003E\u003Col class=\u0022cit-auth-list\u0022\u003E\u003Cli\u003E\u003Cspan class=\u0022cit-auth\u0022\u003E\u003Cspan class=\u0022cit-name-surname\u0022\u003EConnolly\u003C\/span\u003E  \u003Cspan class=\u0022cit-name-given-names\u0022\u003ESJ\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. \u003Cspan class=\u0022cit-article-title\u0022\u003EN Engl J Med\u003C\/span\u003E \n               \u003Cspan class=\u0022cit-pub-date\u0022\u003E2009\u003C\/span\u003E;\u003Cspan class=\u0022cit-vol\u0022\u003E361\u003C\/span\u003E; 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