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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\u003EMultiple factors associated with the Renal Denervation in Patients With Uncontrolled Hypertension trial [SYMPLICITY HTN-3; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01418261\u0026amp;atom=%2Fspmdc%2F14%2F18%2F13.2.atom\u0022\u003ENCT01418261\u003C\/a\u003E] may have contributed to its failure to meet the primary endpoint of change in office blood pressure at Month 6 according to data from a sub-analysis of this trial.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ERenal Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHypertension \u0026amp; Kidney Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHypertensive Disease\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ERenal Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHypertension \u0026amp; Kidney Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology \u0026amp; Cardiovascular Medicine\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHypertensive Disease\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EMultiple factors associated with the Renal Denervation in Patients With Uncontrolled Hypertension trial [SYMPLICITY HTN-3; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01418261\u0026amp;atom=%2Fspmdc%2F14%2F18%2F13.2.atom\u0022\u003ENCT01418261\u003C\/a\u003E] may have contributed to its failure to meet the primary endpoint of change in office blood pressure at Month 6, according to George L. Bakris, MD, University of Chicago Medicine, Chicago, Illinois, USA, who presented data from a sub-analysis of this trial.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe sham arm of the SYMPLICITY HTN-3 trial demonstrated a greater than expected reduction in systolic blood pressure (SBP) [Bhatt DL et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2014]. This may in part explain the lack of efficacy for the primary endpoint of the trial. The purpose of this sub-analysis was to determine the significance of several potential confounders that may have driven the effect observed in the sham arm, including procedural changes, change in antihypertensive therapy, variability in adherence, and differences in patient populations according to different geographic regions.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EIn the prospective, sham-controlled, SYMPLICITY HTN-3 trial, 535 patients with severe resistant hypertension were randomly assigned in a 2:1 fashion to undergo renal denervation (RDN) or a sham procedure. Resistant hypertension was defined as patients who had been prescribed 3 or more antihypertensive medications at maximally tolerated doses. There was no significant difference in change in SBP between the 2 arms at 6 months, as the sham arm demonstrated a significant change in SBP from baseline (p\u0026lt;0.001).\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EIn the sub-analysis, procedural variability was analyzed such that the mean number of ablations in patients who underwent RDN was matched 1:1 using propensity scores. Patients were categorized according to 4 quadrant ablations in both, one, or neither renal artery. As the number of ablations increased, there was a trend toward a progressive decrease in office SBP in the patients who underwent RDN. There was, however, a similar, trend in the patients who underwent the sham procedure, with BP decreasing with an increasing number of ablations.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EBaseline predictors of BP improvement in patients in the sham arm included the use of alpha-blockers, higher baseline office BP readings, the use of aldosterone antagonists, and the total number of intervention attempts. However, vasodilator use was inversely associated with response in both the sham and RDN arms. A secondary analysis of potential racial differences demonstrated that black patients were less likely to improve in the sham arm compared with patients who were not black.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EGeographic location also led to some notable differences. Patients who lived in the Northeastern United States (Boston-New York region) demonstrated a change in office BP, albeit to a lesser extent in ambulatory BP. However, the results for patients living in the Southwestern, Southern, or Western United States reflected that of the original trial. It is unclear as to why there was a difference based on geographic location.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EDr. Bakris concluded by stating that there were some limitations in the SYMPLICITY HTN-3 trial that may have led to the neutral results with RDN for the primary endpoint. He further suggested that the limitations discussed in his presentation were exploratory and were meant to be hypothesis-generating.\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\/18\/13.2.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_openurl.js?nzp1b3\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}