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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\u003EPreviously, the Randomized Evaluation of Long-Term Anticoagulation Therapy [RE-LY] trial evaluated two doses of dabigatran (110 and 150 mg BID; open dabigatran but blinded dose) versus warfarin (open-label) in patients with nonvalvular atrial fibrillation and at least 1 risk factor for stroke [Flaker et al. \u003Cem\u003EJ Am Coll Cardiol\u003C\/em\u003E 2012]. The goal of the RELY-ABLE extension study [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00808067\u0026amp;atom=%2Fspmdc%2F12%2F18%2F25.atom\u0022\u003ENCT00808067\u003C\/a\u003E] was to describe the long-term efficacy and safety of ongoing dabigatran therapy after the RE-LY trial.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EThrombotic Disorders\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECerebrovascular Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EArrhythmias\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EPreviously, the Randomized Evaluation of Long-Term Anticoagulation Therapy [RE-LY] trial evaluated two doses of dabigatran (110 and 150 mg BID; open dabigatran but blinded dose) versus warfarin (open-label) in patients with nonvalvular atrial fibrillation and at least 1 risk factor for stroke [Flaker et al. \u003Cem\u003EJ Am Coll Cardiol\u003C\/em\u003E 2012]. The goal of the RELY-ABLE extension study [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00808067\u0026amp;atom=%2Fspmdc%2F12%2F18%2F25.atom\u0022\u003ENCT00808067\u003C\/a\u003E] presented by Stuart J. Connolly, MD, McMaster University, Hamilton, Ontario, Canada, was to describe the long-term efficacy and safety of ongoing dabigatran therapy after the RE-LY trial.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EPatients who had been randomized to dabigatran and were still taking it at then end of the the blinded dose of dabigatran taken in RE-LY trial were eligible for the was continued in the RELY-ABLE extension study. Patients continued on the same dose of dabigatran (the dose of dabigatran remained blinded) trial for a mean of 2.3 years. In the RE-LY trial, patients were randomized to dabigatran 110 mg (n=6015) or dabigatran 150 mg (n=6076) in a blinded fashion, or open-label warfarin (n=6022). Among these, 4492 (75%) in the 110-mg arm and 4519 (75%) in the 150-mg arm completed RE-LY and were still receiving dabigatran. Of these, 3395 (76%) in the 110-mg arm and 3397 (75%) in the 150-mg arm were beeing followed at a site participating in RELY-ABLE.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EA total of 2914 patients receiving dabigatran 110 mg and 2937 patients receiving dabigatran 150 mg were enrolled in RELY-ABLE, and 2511 and 2508 patients, respectively, completed the study, representing 86% and 85% of the patients.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EDuring 2.3 years of additional dabigatran treatment after RE-LY (total mean follow up of 4.3 years), rates of stroke and major bleeding remained low and comparisons of the 2 doses were consistent with those observed during the main RE-LY trial. The rates of stroke and myocardial infarction (MI) from the RELY-ABLE and RELY trials are compared in \u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E.\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\/13099\/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\/13099\/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\/13099\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-6\u0022 class=\u0022first-child\u0022\u003ERELY-ABLE and RE-LY Efficacy Outcomes for Dabigatran 110 and 150 mg.\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\u003EAt a mean follow-up of 2.3 years, the cumulative risk of stroke or systemic embolism was 1.46%\/year with 150 mg dabigatran versus 1.60%\/year with dabigatran 110 mg (HR, 0.91; 95% CI, 0.69 to 1.20). Other endpoint results at 2.3 years were stroke, 1.24%\/year with dabigatran 150 mg versus 1.38%\/year with dabigatran 110 mg (HR, 0.89; 95% CI, 0.66 to 1.21); ischemic stroke, 1.15%\/year versus 1.24%\/year (HR, 0.92; 95% CI, 0.67 to 1.27); hemorrhagic stroke, 0.13%\/year versus 0.14%\/year (HR, 0.89; 95% CI, 0.34 to 2.30); MI, 0.69%\/year versus 0.72%\/year (HR, 0.96; 95% CI, 0.63 to 1.45); and pulmonary embolism, 0.13%\/year versus 0.11%\/year (HR, 1.14; 95% CI, 0.41 to 3.15).\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EStroke and systemic embolism results for patients in the RELY-ABLE study who received 150 mg versus 110 mg dabigatran at a mean follow-up of 4.25 years (were 0.89%\/year versus 1.05%\/year at a mean follow-up of 4.25 years,) and 1.25%\/year versus 1.54%\/year in all dabigatran patients (RE-LY and RELY-ABLE) at a mean follow-up of 3 years. (1.25%\/year vs 1.54%\/year).\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003EPatients treated with dabigatran 150 mg had higher rates of major bleeding (3.74%\/year) compared with dabigatran 110 mg (2.99%\/year) at 2.3 years in the RELY-ABLE extension study. Life-threatening, intracranial, and extracranial bleeding were higher with 150 mg versus 110 mg dabigatran, whereas GI and fatal bleeding were similar in both groups. Total mortality in the RELY-ABLE study at 2.3 years follow up with 150 mg versus 110 mg dabigatran was 3.02%\/year and 3.10%\/year.\u003C\/p\u003E\u003Cp id=\u0022p-11\u0022\u003EPatients in both dabigatran dose groups had very low rates of hemorrhagic stroke over more than 4 years. Patients who continued in RELY-ABLE treated with 150 mg compared with 110 mg of dabigatran had low ischemic stroke\/systemic emboli rates (1.46%\/year and 1.60%\/year, respectively) but higher major bleeding rates (3.74%\/year and 2.99%\/year, respectively). These two doses of dabigatran were associated with similar mortality rates. Whether the trade-off between the yearly risk of stroke\/embolism protection and major bleeding changes over time, and whether a break-even point exists when that trade-off becomes equivalent or even unfavorable, deserves further study.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2012 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\/12\/18\/25.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?nzn6n1\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?nzn6n1\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}