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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\u003EStroke prevention in atrial fibrillation is an evolving story and it is often predicted that the he new oral anticoagulants that are now reaching the market offer numerous advantages over vitamin K antagonists, including oral administration, therapeutic stability that does not require monitoring, once- or twice-daily administration, and a short half-life.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EArrhythmias\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EStroke prevention in atrial fibrillation (AF) is an evolving story, noted Michael D. Ezekowitz, MBchB, DPhil, Thomas Jefferson Medical School, Philadelphia, Pennsylvania, USA, who predicts that the use of vitamin K antagonists (VKAs) in clinical practice will eventually be replaced by newer anticoagulants and that antiplatelet agents will continue to play less of a role in stroke prophylaxis.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe new oral anticoagulants that are now reaching the market offer numerous advantages over VKAs, including oral administration, therapeutic stability that does not require monitoring, once- or twice-daily administration, and a short half-life, said Elaine M. Hylek, MD, Boston University School of Medicine, Boston, Massachusetts, USA.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EDr. Hylek discussed the results of the Stroke Prevention Using the Oral Direct Factor Xa Inhibitor Rivaroxaban Compared with Warfarin in Patients with Nonvalvular Atrial Fibrillation trial (ROCKET AF; see page 12 of this issue). The study involved 14,264 patients who were randomized to either rivaroxaban or warfarin. The patient population had a median age of 73 years, and 44% was aged 75 years or older, which is considerably older than populations who have enrolled in other recent trials of atrial fibrillation (AF). Participants were also higher risk than those of other contemporary trials, with 0%, 13%, and 87% of patients with CHADS\u003Csub\u003E2\u003C\/sub\u003E scores of 0\u20131, 2, and 3 or more compared with approximately 33% in each group in the RE-LY trial.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EThe primary endpoint of ROCKET AF was stroke or non-CNS systemic embolism, and the primary safety evaluation was the composite endpoint of major or nonmajor clinically relevant bleeding. The trial was evaluated for noninferiority with a per-protocol (PP) analysis and superiority with an intention-to-treat (ITT) analysis.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThe PP analysis demonstrated an event rate of 1.71% per year in the rivaroxaban group compared with 2.16% per year in the warfarin group (HR, 0.79; 95% CI, 0.65 to 0.95; p=0.015), while the ITT analysis showed an annualized event rate of 2.12% with rivaroxaban versus 2.42% with warfarin (p=0.117), demonstrating noninferiority but not superiority [Califf RM et al. AHA 2010].\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EThe relative risk reduction of intracranial bleeding was 33% with rivaroxaban compared with warfarin (p=0.019), although there was a trend toward major bleeding events with rivaroxaban (HR, 1.04; 95% CI, 0.90 to 1.20; p=0.576).\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EDr. Ezekowitz focused on dabigatran, recently approved in the United States at the 150-mg and 75-mg daily doses, and apixaban, which is in late-stage clinical trials. Since 80% of dabigatran clearance occurs through the kidneys, dosing depends on kidney function. Twenty-five percent of apixaban is excreted via the kidneys and metabolized through the CYP3A4 pathway. No routine monitoring is required for either drug, and neither affects liver function.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EDabigatran was approved to prevent stroke and systemic embolic events (SEEs) in patients with AF, based on data from the Randomized Evaluation of Long-term anticoagulant therapY noninferiority trial (RE-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%2F10%2F10%2F28.atom\u0022\u003ENCT00262600\u003C\/a\u003E), in which 18,113 patients with AF and stroke risk were randomized to receive 110 mg or 150 mg dabigatran BID (blinded) or adjusted-dose warfarin (unblinded) [Connolly SJ et al. \u003Cem\u003ENew Engl J Med\u003C\/em\u003E 2009].\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003EThe approval of the 150-mg dose of dabigatran was based on the reduction in stroke\/SEEs relative to warfarin. Annual rates of stroke or systemic embolism were 1.69% in the warfarin group versus 1.11% in the 150-mg dabigatran group (RR, 0.65; 95% CI, 0.52 to 0.81; p\u0026lt;0.001 for superiority) [Connolly SJ. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2010]. The annual rates of major bleeding were 3.63% in the warfarin group versus 3.11% in the 150-mg dabigatran group (p=0.31). Importantly, the relative benefits of dabigatran remained consistent, regardless of whether the patient previously had been treated with a VKA, and were also independent of CHADS\u003Csub\u003E2\u003C\/sub\u003E score (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E).\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\/10\/10\/28\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022RE-LY: Stroke and Systemic Embolism in Patients Stratified by CHADS2 Risk Score.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-291791552\u0022 data-figure-caption=\u0022\u0026amp;lt;div xmlns=\u0026amp;quot;http:\/\/www.w3.org\/1999\/xhtml\u0026amp;quot;\u0026amp;gt;RE-LY: Stroke and Systemic Embolism in Patients Stratified by CHADS\u0026amp;lt;sub\u0026amp;gt;2\u0026amp;lt;\/sub\u0026amp;gt; Risk Score.\u0026amp;lt;\/div\u0026amp;gt;\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\/10\/10\/28\/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\/10\/10\/28\/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\/10\/10\/28\/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\/11405\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-11\u0022 class=\u0022first-child\u0022\u003ERE-LY: Stroke and Systemic Embolism in Patients Stratified by CHADS\u003Csub\u003E2\u003C\/sub\u003E Risk Score.\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EReproduced with permission from M. Ezekowitz, MBcchB, DPhil.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-12\u0022\u003EApixaban is still under investigation, but results from the Phase 3 Apixaban versus Acetylsalicylic Acid to Prevent Strokes (AVERROES; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00496769\u0026amp;atom=%2Fspmdc%2F10%2F10%2F28.atom\u0022\u003ENCT00496769\u003C\/a\u003E) trial were presented at the European Society of Cardiology 2010 Congress. This study enrolled 5600 patients with AF who were unsuitable for VKA therapy. Patients were randomized to the study drug or aspirin and followed for 36 months or until study end. The trial was ended early after an interim analysis showed that apixaban reduced the rate of stroke\/SEEs by 54% compared with aspirin (1.6 vs 3.6; RR, 0.46; 95% CI, 0.33 to 0.64), with no significantly increased risk in bleeding (RR, 1.14; 95% CI, 0.74 to 1.75; p=0.56) [Connolly SJ et al. ESC 2010].\u003C\/p\u003E\u003Cp id=\u0022p-13\u0022\u003EAlthough there was a signal of more frequent myocardial infarctions in RE-LY with dabigatran, the modest absolute difference was outweighed by the major benefit that was observed in stroke reduction. Of note, safety during cardioversion also was similar between dabigatran and warfarin, an important clinical observation.\u003C\/p\u003E\u003Cp id=\u0022p-14\u0022\u003EIn addition to these and other new anticoagulants (eg, edoxaban, betrixaban), several antiarrhythmic drug options are also under investigation. These include vernakalant, which has a unique ion channel-blocking profile, inhibiting the frequency- and voltage-dependent I\u003Csub\u003ENa\u003C\/sub\u003E; early activating K+ channel and I\u003Csub\u003EKACh\u003C\/sub\u003E, and amiodarone analogs (budiodarone, dronedarone) with improved safety profiles.\u003C\/p\u003E\u003Cp id=\u0022p-15\u0022\u003EStefan H. Hohnloser, MD, JW Goethe University, Frankfurt, Germany, discussed the Active-controlled, multicenter, superiority study of Vernakalant injection versus amiodarone in subjects with recent onset atrial fibrillation (AVRO; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00668759\u0026amp;atom=%2Fspmdc%2F10%2F10%2F28.atom\u0022\u003ENCT00668759\u003C\/a\u003E) trial. More than half of patients who were assigned to intravenous vernakalant (51.7%) reached the primary efficacy point of time to conversion (TTC) from AF to sinus rhythm in 90 minutes compared with just 5.2% of the amiodarone group (p\u0026lt;0.0001), with a median TTC in vernakalant responders of 11 minutes (\u003Ca id=\u0022xref-fig-2-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F2\u0022\u003EFigure 2\u003C\/a\u003E) [Camm AJ et al. \u003Cem\u003EJACC\u003C\/em\u003E In Press].\u003C\/p\u003E\u003Cdiv id=\u0022F2\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\/10\/10\/28\/F2.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022AVRO: TTC from AF to SR Within 90 Minutes.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-291791552\u0022 data-figure-caption=\u0022AVRO: TTC from AF to SR Within 90 Minutes.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 2.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/10\/10\/28\/F2.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\/10\/10\/28\/F2.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 2.\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\/10\/10\/28\/F2.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\/11409\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 2.\u003C\/span\u003E \n            \u003Cp id=\u0022p-16\u0022 class=\u0022first-child\u0022\u003EAVRO: TTC from AF to SR Within 90 Minutes.\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-2\u0022\u003EReproduced with permission from S. Hohnloser, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-17\u0022\u003EAn oral formulation of vernakalant is under development, with a Phase 2b trial demonstrating significant superiority of the 500-mg dose over placebo in patients with AF duration of 3 days to 6 months who had been stratified by their baseline medication. While the median time to relapse in the placebo group was 29 days, it was greater than 90 days in the 500-mg group (p=0.0275, log-rank).\u003C\/p\u003E\u003Cp id=\u0022p-18\u0022\u003EBudiodarone is an amiodarone analog with non-CYP450-mediated metabolism, a lower volume of distribution, and a much shorter half-life than its cousin. The Paroxysmal Atrial fibrillation Study with Continuous Atrial fibrillation Logging (PASCAL) study was the first AF trial to use pacemaker memory to document the recurrence of AF. Patients were randomized to either budiodarone or placebo for 12 weeks. The budiodarone cohorts demonstrated a dose-dependent decrease in AF burden, with an almost 75% reduction in the highest-dose (600 mg BID) group compared with a slight increase in the placebo group (p=0.0056) [Ezekowitz M et al. Heart Rhythm 2009].\u003C\/p\u003E\u003Cp id=\u0022p-19\u0022\u003EDronedarone, which is already approved in many countries, can be considered a pleiotropic drug, given the variety of its effects. It blocks several ion channels but also has rate-controlling effects, reduces blood pressure, has the capacity for vasodilation, and has antifibrillatory effects in the ventricles as well as the atria [Gautier P et al. J \u003Cem\u003ECardiovasc Pharmacol\u003C\/em\u003E 2003; Doggrell SA et al. \u003Cem\u003EExpert Opin Investig Drugs\u003C\/em\u003E 2004; Singh BN et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2007]. It is currently being studied in 10,800 patients with permanent AF to assess the effects on major CV events and first unplanned CV hospitalization or death from any cause.\u003C\/p\u003E\u003Cp id=\u0022p-20\u0022\u003EIn conclusion, Dr. Ezekowitz noted that \u201cthe future looks good for those of us that take care of these patients with respect to the ease of care and the benefits the patients will derive from these innovations.\u201d\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2010 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\/10\/10\/28.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_figures.js?nzmnm3\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_openurl.js?nzmnm3\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}