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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\u003EA large, prospective, randomized trial was conducted at 45 sites in the United States to compare the safety and efficacy of transcatheter aortic valve replacement (TAVR) with the CoreValve self-expanding prosthesis with surgical aortic-valve replacement (SAVR) in patients with severe aortic stenosis at high risk for cardiac surgery. This article presents the results from the patients in the high-risk cohort who were randomized to either CoreValve or surgery [Adams DH et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2014].\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EValvular Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices Cardiology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EValvular Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology \u0026amp; Cardiovascular Medicine\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EA large, prospective, randomized trial was conducted at 45 sites in the United States to compare the safety and efficacy of transcatheter aortic valve replacement (TAVR) with the CoreValve self-expanding prosthesis with surgical aortic-valve replacement (SAVR) in patients with severe aortic stenosis at high risk for cardiac surgery. Results from the cohort of patients who were not surgical candidates and underwent TAVR with CoreValve were recently reported [Popma JJ et al. \u003Cem\u003EJ Am Coll Cardiol\u003C\/em\u003E 2014]. David H. Adams, MD, Mount Sinai Medical Center, New York, New York, USA, presented the results from the patients in the high-risk cohort who were randomized to either CoreValve or surgery [Adams DH et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2014].\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003ETo participate in the trial, patients had to have NYHA Functional Class \u2265II, severe aortic stenosis, mortality risk with surgery \u226515%, and risk of death or irreversible complications within 30 days \u0026lt;50%. Surgical risk was determined by using the Society of Thoracic Surgeons (STS) Predicted Risk of Mortality Calculator in conjunction with other key risk factors. Key exclusion criteria included recent active gastrointestinal bleed, stroke, myocardial infarction, or recent procedures with bare-metal or drug-eluting stents. Patients with significant untreated coronary artery disease, a left ventricular ejection fraction \u0026lt;20%, creatinine clearance \u0026lt;20 mL\/min, or a life expectancy \u0026lt;1 year were also excluded. Patients meeting entry criteria were randomized 1:1 to TAVR by any route or SAVR. Patients will be followed for a total 5 years, but the primary endpoint was all-cause mortality at 1 year.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EOf the 795 patients randomized, 390 underwent TAVR and 357 underwent SAVR. The mean STS predicted risk of mortality score was 7.3% \u00b1 3.0 for TAVR compared with 7.5% \u00b1 3.4 for SAVR. The proportion of patients with severe chronic lung disease was 13.3% for TAVR versus 9.0% in the SAVR group. Approximately 98% of TAVR patients and 94% of SAVR patients completed the 1-year follow-up assessments.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EOne-year mortality was lower in the TAVR arm (14.2%) compared with the SAVR arm (19.1%; p\u0026lt;0.001 for noninferiority and p=0.04 for superiority). The TAVR survival advantage was also evident in all subgroups. At 1 year, TAVR patients had higher rates of major vascular complications and pacemaker implants, but lower rates of bleeding, new onset or worsening atrial fibrillation, and acute kidney injury compared with SAVR (\u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E). SAVR patients had significantly lower paravalvular regurgitation at each time point (p\u0026lt;0.001). Dr. Adams noted that additional analyses will be reported in the future including long-term outcomes.\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\/15807\/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\/15807\/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\/15807\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\u003EProcedural Outcomes at 1 Year\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-7\u0022\u003EAdditional analyses of the follow-up data will be reported, which is important given the mortality benefit is statistically fragile\u2014if mortality had been different by just one patient the results would not have been significant\u2014and higher major vascular complication rates and pacemaker use have unclear long-term consequences at present.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2014 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\/14\/4\/13.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?nzpb9d\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?nzpb9d\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}