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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\u003ETranscatheter aortic valve replacement was not superior to surgical aortic valve replacement in the randomized NOTION trial of low-risk patients with aortic valve stenosis. The transcatheter procedure did not significantly reduce the composite rate of death from any cause, stroke, or myocardial infarction at 1 year compared with surgery.\u003C\/p\u003E\n\u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Eaortic stenosis\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Esurgical aortic valve replacement\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Etranscatheter aortic valve replacement\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENCT01057173\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENOTION\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ecardiology \u0026amp; cardiovascular medicine clinical trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Emyocardial infarction\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n\n\u003Cp id=\u0022p-2\u0022\u003EIn the first \u201call-comers\u201d trial to randomize low-risk patients with aortic valve stenosis to transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR), TAVR was safe and effective but not superior to SAVR on the primary outcome, the composite rate of death from any cause, stroke, or myocardial infarction (MI) at 1 year. Hans Gustav H\u00f8rsted Thyregod, MD, Copenhagen University Hospital, Copenhagen, Denmark, presented results from the prospective, randomized, multicenter, nonblinded NOTION trial [Thyregod HGH et al. \u003Cem\u003EJ Am Coll Cardiol.\u003C\/em\u003E 2015].\u003C\/p\u003E\n\u003Cp id=\u0022p-3\u0022\u003EIn previous studies of patients with extreme-risk aortic stenosis (AS) (Society of Thoracic Surgeons [STS] score \u0026gt;\u200515%) not considered as candidates for SAVR, the rate of the composite end point of death from any cause was 50.7% for standard therapy vs 30.7% for TAVR at 1 year [Leon MB et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E. 2010]. The rate of all-cause mortality or major stroke at 1 year was 26% for TAVR-treated patients vs a prespecified objective performance goal of 43% [Popma JJ et al. \u003Cem\u003EJ Am Coll Cardiol\u003C\/em\u003E. 2014]. In high-risk patients (STS score 10% to 15%) randomly assigned to TAVR or SAVR, rates of death from any cause at 1 year were 24.2% for TAVR vs 26.8% for SAVR [Smith CR et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E. 2011] and 14.2% for TAVR vs 19.1% for SAVR [Adams DH et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E. 2014].\u003C\/p\u003E\n\u003Cp id=\u0022p-4\u0022\u003EThe objective of the NOTION trial was to compare TAVR with SAVR in an all-comers population of surgery-eligible patients aged \u2265\u200570 years. Investigators randomized 280 patients (mean age 79 years; 53% men) with low-risk severe aortic valve stenosis (mean STS score 3%) who were expected to live \u0026gt;\u20051 year to TAVR (n\u2005=\u2005145) or SAVR (n\u2005=\u2005135). The primary outcome was a composite of death from any cause, stroke, or MI at 1 year. Secondary outcomes included safety and efficacy and echocardiographic outcomes. Baseline characteristics and comorbidities were not significantly different in the 2 groups.\u003C\/p\u003E\n\u003Cp id=\u0022p-5\u0022\u003EIn intention-to-treat analysis, the composite rate of death from any cause, stroke, or MI at 1 year was 13.1% for TAVR vs 16.3% for SAVR (\u003Cem\u003EP\u003C\/em\u003E\u2005=\u2005.43). In as-treated analysis, rates for the primary end point also failed to reach statistical significance (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E).\u003C\/p\u003E\n\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\/15\/5\/17.2\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Death From Any Cause, Stroke, or Myocardial Infarction at 1 Year in As-Treated PopulationMI, myocardial infarction; SAVR, surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement.Reproduced with permission from HGH Thyregod, MD.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-2028743267\u0022 data-figure-caption=\u0022Death From Any Cause, Stroke, or Myocardial Infarction at 1 Year in As-Treated PopulationMI, myocardial infarction; SAVR, surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement.Reproduced with permission from HGH Thyregod, MD.\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\/15\/5\/17.2\/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\/15\/5\/17.2\/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\/15\/5\/17.2\/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\/16197\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\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \u003Cp id=\u0022p-6\u0022 class=\u0022first-child\u0022\u003EDeath From Any Cause, Stroke, or Myocardial Infarction at 1 Year in As-Treated Population\u003C\/p\u003E\n\u003Cp id=\u0022p-7\u0022\u003EMI, myocardial infarction; SAVR, surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement.\u003C\/p\u003E\n\u003Cp id=\u0022p-8\u0022\u003EReproduced with permission from HGH Thyregod, MD.\u003C\/p\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n\u003Cp id=\u0022p-9\u0022\u003EThe only secondary outcomes to achieve statistical significance at 1 year were rates of atrial fibrillation (TAVR, 21.2% [n\u2005=\u2005142]; SAVR, 59.4% [n\u2005=\u2005134]; \u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.001) and pacemaker implantation (TAVR, 38%; SAVR, 2.4%; \u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.001). Among surviving patients at 1 year, 67.4% in the TAVR group (n\u2005=\u2005132) were NYHA class I compared with 81.7% in the SAVR group (n\u2005=\u2005120). A statistically significant difference (\u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.001) favoring TAVR was seen for aortic valve performance (\u003Ca id=\u0022xref-fig-2-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F2\u0022\u003EFigure 2\u003C\/a\u003E). Rates of moderate-to-severe aortic valve regurgitation were 15.7% for TAVR vs 0.9% for SAVR at 1 year.\u003C\/p\u003E\n\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\/15\/5\/17.2\/F2.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Aortic Valve PerformanceSAVR, surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement.*P \u0026amp;lt; .001.Reproduced with permission from HGH Thyregod, MD.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-2028743267\u0022 data-figure-caption=\u0022\u0026amp;lt;div xmlns=\u0026amp;quot;http:\/\/www.w3.org\/1999\/xhtml\u0026amp;quot;\u0026amp;gt;Aortic Valve PerformanceSAVR, surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement.*\u0026amp;lt;em\u0026amp;gt;P\u0026amp;lt;\/em\u0026amp;gt; \u0026amp;amp;lt; .001.Reproduced with permission from HGH Thyregod, MD.\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 2.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/5\/17.2\/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\/15\/5\/17.2\/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\/15\/5\/17.2\/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\/16198\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\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 2.\u003C\/span\u003E \u003Cp id=\u0022p-10\u0022 class=\u0022first-child\u0022\u003EAortic Valve Performance\u003C\/p\u003E\n\u003Cp id=\u0022p-11\u0022\u003ESAVR, surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement.\u003C\/p\u003E\n\u003Cp id=\u0022p-12\u0022\u003E*\u003Cem\u003EP\u003C\/em\u003E \u0026lt; .001.\u003C\/p\u003E\n\u003Cp id=\u0022p-13\u0022\u003EReproduced with permission from HGH Thyregod, MD.\u003C\/p\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n\u003Cp id=\u0022p-14\u0022\u003EIn summary, the NOTION trial failed to demonstrate that TAVR was superior to SAVR for the primary outcome of the composite rate of death from any cause, stroke, or MI after 1 year in patients with low-risk severe AS. Dr Thyregod concluded that long-term durability and morbidity data were required in lower-risk patients.\u003C\/p\u003E\n\u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2015 SAGE Publications\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\/15\/5\/17.2.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?nzlp62\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?nzlp62\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}