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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\u003ETreatment with bendavia in patients receiving percutaneous coronary intervention for STEMI in the EMBRACE STEMI trial did not result in a reduction in reperfusion injury-related outcomes compared with placebo. However, these data have led to further hypotheses, which are currently under investigation in clinical trials.\u003C\/p\u003E\n\u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EEMBRACE\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ESTEMI\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ebendavia\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ereperfusion injury\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Epercutaneous coronary intervention\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Estenting\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ecardiology \u0026amp; cardiovascular medicine clinical trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENCT01572909\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n\n\u003Cp id=\u0022p-2\u0022\u003EC. Michael Gibson, MD, MS, Harvard Medical School, Boston, Massachusetts, USA, presented results from the EMBRACE trial [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01572909\u0026amp;atom=%2Fspmdc%2F15%2F5%2F11.atom\u0022\u003ENCT01572909\u003C\/a\u003E], which investigated the effect of bendavia administration on reperfusion injury in patients receiving percutaneous coronary intervention (PCI) and stenting for STEMI. EMBRACE was an international, multicenter trial designed to investigate the effect of bendavia on infarct size in patients with first-time anterior STEMI. Patients were required to present with a closed artery and a TIMI flow of 0 or 1 in proximal or mid left anterior descending lesions, and within 4 hours of symptoms. Patients with shock were excluded. The primary analysis population was smaller than planned due to low numbers of patients presenting with complete obstruction on angiography.\u003C\/p\u003E\n\u003Cp id=\u0022p-3\u0022\u003EMitochondria present a potential target for pharmacotherapy to lower reperfusion injury. In animal studies, bendavia, a mitochondria-targeting peptide, has reduced infarct size following ischemic events up to 42% [Kloner RA et al. \u003Cem\u003EJ Am Heart Assoc\u003C\/em\u003E. 2012], and improvements occur with no changes in heart rate or blood pressure [Sabbah HN et al. \u003Cem\u003EEur Heart J\u003C\/em\u003E. 2013 (abstr P3286)]. These results showed promise of improved mitochondrial bioenergetics without increased demands on the heart.\u003C\/p\u003E\n\u003Cp id=\u0022p-4\u0022\u003EPatients were randomized 1:1 and were blinded to treatment with bendavia (n\u2005=\u2005150) or volume-matched placebo (n\u2005=\u2005147). Bendavia IV was administered at 0.05 mg\/kg\/h at least 15 minutes prior to, and 60 minutes following, PCI. The primary end point was the area under the curve (AUC) for serum creatine kinase MB (CK-MB) levels over 72 hours post-PCI. The clinical end point was a composite of all-cause death, new-onset congestive heart failure (CHF), and CHF rehospitalization. Secondary end points included infarct size by the AUC for troponin I, magnetic resonance imaging outcomes, TIMI perfusion grade and corrected TIMI frame count post-PCI, and ST-elevation resolution.\u003C\/p\u003E\n\u003Cp id=\u0022p-5\u0022\u003EOf 297 randomized patients, an unexpected 117 (40%) had an open artery at angiography (pre-PCI TIMI flow grade\u2005\u0026gt;\u20051) and were excluded from the analysis. After satisfying all patient exclusions, the primary analysis population was 118; patients were excluded from the treatment arms equally. Baseline characteristics were similar except hypertension (60% in placebo group vs 37.9% in treatment group). Other clinical and angiographic characteristics were similar.\u003C\/p\u003E\n\u003Cp id=\u0022p-6\u0022\u003EThe primary end point in the study showed no significant difference between the study drug group and the placebo group. No differences were seen in the clinical composite end point or any secondary end points. The exploratory end point of CHF was numerically lower with bendavia at 8 hours following treatment; however, this difference was not statistically significant (\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\/11\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022CHF Probability for 24 Hours Following PCICHF, congestive heart failure; PCI, percutaneous coronary intervention.Reproduced with permission from CM Gibson, MS, MD.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1812568\u0022 data-figure-caption=\u0022CHF Probability for 24 Hours Following PCICHF, congestive heart failure; PCI, percutaneous coronary intervention.Reproduced with permission from CM Gibson, MS, 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\/11\/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\/11\/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\/11\/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\/16191\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-7\u0022 class=\u0022first-child\u0022\u003ECHF Probability for 24 Hours Following PCI\u003C\/p\u003E\n\u003Cp id=\u0022p-8\u0022\u003ECHF, congestive heart failure; PCI, percutaneous coronary intervention.\u003C\/p\u003E\n\u003Cp id=\u0022p-9\u0022\u003EReproduced with permission from CM Gibson, MS, 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-10\u0022\u003ENon-prespecified, exploratory analyses found potential benefit in patients with hypertension who received bendavia for infarct volume and ST-segment resolution, and a trend toward benefit for edema volume. Exploratory analyses showed several protective renal outcomes associated with bendavia.\u003C\/p\u003E\n\u003Cp id=\u0022p-11\u0022\u003EDr Gibson concluded by reiterating that no differences were seen between bendavia and placebo in terms of the CK-MB AUC, but added that these data generated hypotheses toward the potential for bendavia to reduce CHF symptoms within 8 hours following PCI, which is under investigation for patients with systolic heart failure in additional clinical trials. The potential renal protective effects of bendavia are also under investigation.\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\/11.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?nzl6u1\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?nzl6u1\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}