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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\u003EResults of the PROMISE trial demonstrated that anatomic testing with computed tomographic angiography in symptomatic patients with suspected coronary artery disease did not improve clinical outcomes when compared with functional testing. The economic substudy also revealed that there was no significant difference in cumulative health care costs between testing strategies.\u003C\/p\u003E\n\u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Ecomputed tomographic angiography\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ecost analysis\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ecoronary artery disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Emyocardial infarction\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPROMISE\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENCT01174550\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ecardiology \u0026amp; cardiovascular medicine clinical trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eimaging modalities\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ecardiology \u0026amp; cardiovascular medicine screening \u0026amp; prevention\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n\n\u003Cp id=\u0022p-2\u0022\u003EPamela S. Douglas, MD, Duke University Medical Center, Durham, North Carolina, USA, presented results of the PROMISE trial [Douglas PS et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E. 2015], demonstrating that a strategy of initial computed tomographic angiography (CTA) in symptomatic patients with suspected coronary artery disease (CAD) who required noninvasive testing did not improve clinical outcomes over a median follow-up of 2 years when compared with functional testing. Daniel B. Mark, MD, Duke University Medical Center, Durham, North Carolina, USA, also reported the results of an economic substudy, revealing that the difference in net cost between the 2 testing strategies was not significantly different.\u003C\/p\u003E\n\u003Cp id=\u0022p-3\u0022\u003EDr Douglas highlighted that new-onset stable chest pain leads to approximately 4 million stress tests annually in the United States in patients without diagnosed heart disease [Ladapo JA et al. \u003Cem\u003EAnn Intern Med\u003C\/em\u003E. 2014]. CTA has the potential to reduce unnecessary invasive testing and improve outcomes due to higher accuracy when compared with functional testing and its ability to detect prognostically important nonobstructive CAD. However, the relative impact of data derived from noninvasive anatomic testing vs functional testing on subsequent management and clinical outcomes had not been elucidated.\u003C\/p\u003E\n\u003Cp id=\u0022p-4\u0022\u003EThe PROMISE trial was a multicenter randomized pragmatic comparative effectiveness trial analyzing whether anatomic testing with CTA, as compared with functional testing with a stress test (ie, exercise electrocardiogram, stress echocardiography, or stress testing with nuclear imaging), would improve the health outcomes of patients with symptoms of potential CAD who require further testing [Douglas PS et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E. 2015]. The primary end points were all-cause mortality, nonfatal myocardial infarction (MI), hospitalization for unstable angina, and major complications from cardiovascular (CV) procedures (eg, stroke, bleeding, renal failure, or anaphylaxis). The secondary end points included the primary end point plus invasive catheterization without obstructive CAD, other components of the primary end point, invasive catheterization without obstructive CAD, cumulative radiation exposure at \u2264\u200590 days, and an economic analysis that was reported separately by Dr Mark.\u003C\/p\u003E\n\u003Cp id=\u0022p-5\u0022\u003EThe study included patients with clinically necessary, nonurgent, noninvasive CV testing; no history of CAD or recent CAD evaluation; men who were aged \u0026gt;\u200554 years or women aged \u0026gt;\u200564 years; or men aged 45 to 54 years or women aged 50 to 64 years with \u2265\u20051 major cardiac risk factor.\u003C\/p\u003E\n\u003Cp id=\u0022p-6\u0022\u003EA total of 10\u2005003 patients were enrolled: 4996 were randomized to CTA and 5007 to a functional testing strategy. Baseline characteristics were similar between the groups. The median follow-up time was 25 months, with a maximum follow-up of 50 months. Nearly 94% of patients received the testing to which they were randomized. At 12 months, loss to follow-up was 2.4% and 3.2% in the CTA and functional-testing strategy arms, respectively, and withdrawal of consent was 2.5% and 4.9%, respectively.\u003C\/p\u003E\n\u003Cp id=\u0022p-7\u0022\u003EDuring follow-up, 3.3% of patients in the CTA group and 3.0% in the functional testing group had a primary end point event (HR, 1.04; 95% CI, 0.83 to 1.29; \u003Cem\u003EP\u2005\u003C\/em\u003E=\u2005.75; \u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E). Results of the prespecified subgroup analyses were consistent with those in the overall population.\u003C\/p\u003E\n\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\/16210\/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\/16210\/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\/16210\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 \u003Cp id=\u0022p-8\u0022 class=\u0022first-child\u0022\u003EClinical End Point Events\u003C\/p\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n\u003Cp id=\u0022p-11\u0022\u003EResults were also not significant for the secondary end point of the composite of the primary end point plus invasive cardiac catheterization (HR, 0.91; 95% CI, 0.78 to 1.06; \u003Cem\u003EP\u003C\/em\u003E\u2005=\u2005.22) or for death or nonfatal MI (HR, 0.88; 95% CI, 0.67 to 1.15; \u003Cem\u003EP\u003C\/em\u003E\u2005=\u2005.35). A lower-than-anticipated event rate may have contributed to these null findings.\u003C\/p\u003E\n\u003Cp id=\u0022p-12\u0022\u003EHowever, the exploratory secondary end point of catheterization showed no obstructive CAD at \u2264\u200590 days and occurred in 3.4% of patients in the CTA group vs 4.3% of those in the functional testing group (\u003Cem\u003EP\u003C\/em\u003E\u2005=\u2005.022). The difference in the cumulative radiation exposure at \u2264\u200590 days was driven by the type of functional test ordered. A comparison of CTA vs stress testing with nuclear imaging revealed lower radiation in the CTA group (10.1 vs 12.0 mSv); however, in comparison to those patients undergoing a stress electrocardiogram or stress echocardiography, radiation in the CTA group was higher. No ionizing radiation exposure was received by 4% of patients in the CTA group vs 33% in the functional group (\u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.001).\u003C\/p\u003E\n\u003Cp id=\u0022p-13\u0022\u003EDr Mark reported results of the economic substudy, whose primary objective was to measure and compare cumulative total costs of each strategy and to estimate the cost-effectiveness of anatomic strategy if it was shown to be superior. Medical costs considered in the calculation included initial diagnostic test technical fees, hospital-based facility costs, and physicians\u2019 fees for testing and hospital services. A total of 96% of patients were included in economic substudy across both testing groups. The results demonstrated that despite somewhat lower testing fees for CTA compared with functional testing, the net cost for CTA was higher, although the increase was not statistically significant (no \u003Cem\u003EP\u003C\/em\u003E value reported). However, Dr Mark cautioned that outpatient medication costs were not included in the cost calculation, and the analysis of data on quality of life and the employment status was not yet completed.\u003C\/p\u003E\n\u003Cp id=\u0022p-14\u0022\u003EDr Douglas concluded that an initial strategy of CTA was not associated with better clinical outcomes than functional testing over a median follow-up of 25 months in this large, community-based population of symptomatic patients with suspected CAD who required noninvasive testing.\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\/4.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?nzlope\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?nzlope\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}