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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.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\u003ECurrent themes in clinical trials include a movement toward large size, composite outcomes, and factorial designs. The studies reported in this session represent all 3 of these trends\u2014most evidently, large study populations.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiac Anesthesia\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EAnesthesiology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiac Anesthesia\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003ECurrent themes in clinical trials include a movement toward large size, composite outcomes, and factorial designs. The studies reported in this session represent all 3 of these trends\u2014most evidently, large study populations.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe Vascular Events in Noncardiac Surgery Patients Cohort Evaluation Study [VISION; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00512109\u0026amp;atom=%2Fspmdc%2F14%2F40%2F17.atom\u0022\u003ENCT00512109\u003C\/a\u003E] was designed to evaluate the prognostic capabilities of troponin T and its role in monitoring patients after surgery. An additional goal was to establish diagnostic criteria for myocardial injury after noncardiac surgery (MINS) and evaluate predictors of 30\u2013day outcomes.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThe study is complete, having enrolled 40 000 patients aged \u2265 45 years who had noncardiac surgery requiring at least 1 overnight hospital stay. Troponin T was measured 6 to 12 hours post\u2013surgery and on days 1, 2, and 3. A fourth\u2013generation troponin T value \u2265 0.04 was considered abnormal. Patients were followed during hospitalization and at 30 days and 1 year.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EAndrea M. Kurz, MD, Cleveland Clinic, Cleveland, Ohio, USA, presented data from the first 15 133 patients. Overall mortality was 1.9%, with 26.6% of deaths occurring at a median of 11 days after discharge; higher peak troponin concentrations were associated with higher 30\u2013day mortality and reduced time to death.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThe investigators have proposed the following definition of MINS: myocardial injury caused by ischemia that has prognostic relevance and occurs within 30 days of surgery. In these patients, a total troponin T level \u2265 0.03 that is of ischemic etiology is an independent predictor of 30\u2013day mortality.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EThe investigators concluded that troponin T is an independent predictor of 30\u2013day mortality and that postoperative myocardial injury is common, with most MINSs detected only by troponin screening. They recommend monitoring troponin concentrations on the first and second days after moderate\u2013to high\u2013risk surgery, with concentrations \u2265 0.03 prompting a cardiology consult.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EThe Perioperative Ischemic Evaluation\u20132 Trial [POISE\u20132; Devereaux PJ et al. \u003Cem\u003EAm Heart J.\u003C\/em\u003E 2014] was a 2 \u00d7 2 factorial controlled phase 3 trial to assess the impact of low\u2013dose clonidine vs placebo and low\u2013dose aspirin vs placebo in patients having noncardiac surgery. The study included surgical inpatients aged \u2265 45 years with a history of vascular disease. Patients who had received bare\u2013metal stents \u0026lt; 6 weeks before surgery or drug\u2013eluting stents \u0026lt; 1 year before surgery were excluded, as were those who took aspirin within 72 hours before surgery.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EParticipants (n = 10 010) were randomized in a 1:1:1:1 ratio to receive clonidine plus aspirin, clonidine plus an aspirin placebo, a clonidine placebo plus aspirin, or a clonidine placebo plus an aspirin placebo. Clonidine (0.2 mg\/d) was started just before surgery and continued until 72 hours after surgery. Aspirin (200 mg) was also started just before surgery but continued at 100 mg\/d for 30 days in patients already taking aspirin (initiation cohort) or 7 days for aspirinna\u00efve patients (continuation cohort). The primary outcome was a death or nonfatal myocardial infarction (MI) at 30 days.\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003EPhilip Devereaux, MD, PhD, McMaster University, Hamilton, Ontario, Canada, discussed the recent results for patients randomized to aspirin vs placebo [Devereaux PJ et al. \u003Cem\u003EN Engl J Med.\u003C\/em\u003E 2014]. There was no difference for aspirin compared with placebo on either the primary or secondary outcomes. There were no interactions with clonidine. Patients taking aspirin had a higher rate of acute kidney injury leading to dialysis when compared with those receiving placebo (HR, 1.75; 95% CI, 1.00 to 3.09; \u003Cem\u003EP\u003C\/em\u003E = .05), as well as an increased incidence of major bleeding (HR, 1.23; 95% CI, 1.01 to 1.49; \u003Cem\u003EP\u003C\/em\u003E = .04). The results were consistent in both the initiation and continuation groups.\u003C\/p\u003E\u003Cp id=\u0022p-11\u0022\u003EUsing multivariable regression analysis, the investigators determined that life\u2013threatening\/ major bleeding preceding an MI independently predicted that a patient would proceed to an infarction. Among patients taking aspirin chronically, there was no increase in thrombotic events due to perioperative withholding of aspirin. The optimal time to restart aspirin appears to be 8 to 10 days after surgery, balancing the benefits against the risk of surgical bleeding.\u003C\/p\u003E\u003Cp id=\u0022p-12\u0022\u003EDaniel I. Sessler, MD, Cleveland Clinic Foundation, Cleveland, Ohio, USA, presented the clonidine results from POISE\u20132 [Devereaux PJ et al. \u003Cem\u003EN Engl J Med.\u003C\/em\u003E 2014]. There was no difference in either the primary or secondary outcome between clonidine and placebo (\u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E). There were no interactions with aspirin. Significantly more subjects in the clonidine group (n = 16) had a non\u2013fatal cardiac arrest as compared with subjects treated with placebo (n = 5; HR, 3.20; 95% CI, 1.17 to 8.73; \u003Cem\u003EP\u003C\/em\u003E = .02).\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\/15104\/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\/15104\/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\/15104\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-13\u0022 class=\u0022first-child\u0022\u003EThirty\u2013Day Results: Primary and Secondary Outcomes\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-16\u0022\u003EClonidine was associated with significantly more clinically important hypotension (HR, 1.32; 95% CI, 1.24 to 1.40) and bradycardia (HR, 1.49; 95% CI, 1.32 to 1.69; both, \u003Cem\u003EP\u003C\/em\u003E \u0026lt; .001). The incidence of stroke did not differ. Hypotension was a clinically important and significant predictor of MI (HR, 1.37; 95% CI, 1.16 to 1.62; \u003Cem\u003EP\u003C\/em\u003E \u0026lt; .001).\u003C\/p\u003E\u003Cp id=\u0022p-17\u0022\u003ERegarding both aspects of the POISE\u20132 trial, neither clonidine nor aspirin reduced postoperative MI or death. Clonidine significantly increased the risk of hypotension, while aspirin increased the risk of major bleeding\u2014both of which are independent predictors of MIs. A safe and effective way of preventing postoperative MI remains to be determined.\u003C\/p\u003E\u003Cp id=\u0022p-18\u0022\u003EThe Nitrous Oxide Anesthesia and Cardiac Morbidity After Major Surgery: A Randomised Controlled Trial [ENIGMA\u2013II; Myles PS et al. \u003Cem\u003ELancet.\u003C\/em\u003E 2014] tested the hypothesis that avoiding nitrous oxide (N\u003Csub\u003E2\u003C\/sub\u003EO) in anesthesia during major surgery reduces the incidence of cardiac complications or death. The results were presented by Paul S. Myles, MB, BS, MPH, MD, Alfred Hospital, Melbourne, Australia.\u003C\/p\u003E\u003Cp id=\u0022p-19\u0022\u003EENIGMA\u2013II was a multinational double\u2013blind phase 4 trial including 7000 noncardiac patients having surgery lasting at least 2 hours. Participants were randomized in a 1:1 ratio to 70% N\u003Csub\u003E2\u003C\/sub\u003EO and 30% O\u003Csub\u003E2\u003C\/sub\u003E (n = 3543) or nitrogen and 30% O\u003Csub\u003E2\u003C\/sub\u003E (n = 3569). The primary end point was death and cardiovascular complications (MI, stroke, cardiac arrest, pulmonary embolism) 30 days after surgery. Secondary outcomes included MI, wound infection, nausea or vomiting, and hospital stay.\u003C\/p\u003E\u003Cp id=\u0022p-20\u0022\u003ESubjects averaged 70 years old; 69% were American Society of Anesthesiologists status 3 or 4. The mean duration of anesthesia was 3.2 hours (range, 2.2 to 4.4). Among patients receiving N\u003Csub\u003E2\u003C\/sub\u003EO, there was a significant reduction in the dose of the volatile anesthetic used as part of the general anesthetic regimen and a significant increase in the use of antiemetic prophylaxis (both \u003Cem\u003EP\u003C\/em\u003E \u0026lt;.001). The 2 groups did not differ in the occurrence of the primary end point, which largely comprised MI in both groups (\u003Ca id=\u0022xref-table-wrap-2-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T2\u0022\u003ETable 2\u003C\/a\u003E). Persistent nausea or vomiting was significantly (\u003Cem\u003EP\u003C\/em\u003E \u0026lt; .001) more common in patients receiving N\u003Csub\u003E2\u003C\/sub\u003EO and persisted for 48 hours. There was no difference in recovery room stay or wound infections.\u003C\/p\u003E\u003Cdiv id=\u0022T2\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\/15105\/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\/15105\/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\/15105\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 2.\u003C\/span\u003E \n            \u003Cp id=\u0022p-21\u0022 class=\u0022first-child\u0022\u003EPrimary Outcomes\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-23\u0022\u003EDr Myles concluded that N\u003Csub\u003E2\u003C\/sub\u003EO is safe to use in most circumstances and its emetogenic properties can be controlled with antiemetic prophylaxis.\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\/40\/17.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?nzomq2\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?nzomq2\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}