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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\u003Cp id=\u0022p-1\u0022\u003EThe ORBIT II study demonstrates that a coronary orbital atherectomy is a potential treatment option for patients with calcified coronary lesions, with potential cost-saving benefits. Patients with diabetes treated with a coronary orbital atherectomy system have similar results to patients without diabetes.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Ecalcified coronary lesion\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ecoronary orbital atherectomy system\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eeconomic analysis\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EORBIT II\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EOAS\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPCI\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Epercutaneous coronary intervention\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ecoronary artery disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ecardiology \u0026amp; cardiovascular medicine clinical trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Einterventional techniques \u0026amp; devices\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Emyocardial infarction\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\u003Cp id=\u0022p-2\u0022\u003EJeffrey W. Chambers, MD, Metropolitan Heart and Vascular Institute, Mercy Hospital, Minneapolis, Minnesota, USA, presented 2-year results of the ORBIT II study [G\u00e9n\u00e9reux P et al. \u003Cem\u003EAm J Cardiol\u003C\/em\u003E. 2015], demonstrating that a coronary orbital atherectomy system (OAS) can be used as a lesion preparation tool prior to stent implantation in patients with severely calcified coronary lesions, and also had potential cost-saving benefits over standard treatment.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe prevalence of risk factors for arterial calcification (eg, advanced age, diabetes, and kidney disease) is increasing rapidly in the United States. Coronary calcium is a predictor of adverse outcomes in patients undergoing percutaneous coronary intervention for acute coronary syndromes [G\u00e9n\u00e9reux P et al. \u003Cem\u003EJ Am Coll Cardiol\u003C\/em\u003E. 2014]. Diamondback 360 is the first novel coronary OAS technology approved by the FDA to specifically treat severely calcified lesions. It utilizes centrifugal sanding action, and Dr Chambers specifically highlighted its simplicity of use.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EORBIT II [G\u00e9n\u00e9reux P et al. \u003Cem\u003EAm J Cardiol\u003C\/em\u003E. 2015] was a prospective, multicenter, nonblinded, single-arm study that evaluated the long-term safety and efficacy of coronary OAS in patients with severely calcified coronary lesions who underwent percutaneous coronary intervention. The objective of the study was to determine whether OAS successfully facilitated stent deployment and was safe in this patient population. The major inclusion criteria were evidence of severe calcification and the target vessel reference diameter between 2.5 mm and 4.0 mm, with the lesion length \u2264\u200540 mm.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EThe study enrolled 443 patients (64.6% men; mean age 71.4 years), with 97.7% of patients obtaining successful stent delivery that resulted in 98.6% of patients having \u0026lt;\u200550% residual stenosis [Chambers JW et al. \u003Cem\u003EJACC Cardiovasc Interv\u003C\/em\u003E. 2014]. The adjudicated safety analysis showed that at 2-year follow-up, cardiac death occurred in 4.3% of patients, target vessel revascularization (TVR)\/ target lesion revascularization (TLR) in 8.1% (TLR, 6.2%; TVR, 2.9%), myocardial infarction in 10.9%, and the composite end point of major adverse cardiac events in 19.4% (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). The subanalysis of the diabetic population revealed that coronary OAS produced similar outcomes in patients with diabetes (n\u2005=\u2005160) vs those without (n\u2005=\u2005283) at 2-year follow-up, with major adverse cardiac events occurring in 20.6% vs 18.7%, respectively.\u003C\/p\u003E\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\/10\/6\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022ORBIT II Safety Outcomes at 2-Year Follow-upCEC, Clinical Events Classification; MACE, major adverse cardiac event; MI, myocardial infarction; TVR\/TLR, target vessel revascularization\/target lesion revascularization.aNot per protocol analysis. Clinically driven evaluation based on CEC adjudication of MI.Reproduced with permission from JW Chambers, MD.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1197661811\u0022 data-figure-caption=\u0022\u0026amp;lt;div xmlns=\u0026amp;quot;http:\/\/www.w3.org\/1999\/xhtml\u0026amp;quot;\u0026amp;gt;ORBIT II Safety Outcomes at 2-Year Follow-upCEC, Clinical Events Classification; MACE, major adverse cardiac event; MI, myocardial infarction; TVR\/TLR, target vessel revascularization\/target lesion revascularization.\u0026amp;lt;sup\u0026amp;gt;a\u0026amp;lt;\/sup\u0026amp;gt;Not per protocol analysis. Clinically driven evaluation based on CEC adjudication of MI.Reproduced with permission from JW Chambers, MD.\u0026amp;lt;\/div\u0026amp;gt;\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\/10\/6\/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\/10\/6\/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\/10\/6\/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\/16673\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-6\u0022 class=\u0022first-child\u0022\u003EORBIT II Safety Outcomes at 2-Year Follow-up\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003ECEC, Clinical Events Classification; MACE, major adverse cardiac event; MI, myocardial infarction; TVR\/TLR, target vessel revascularization\/target lesion revascularization.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003E\u003Csup\u003Ea\u003C\/sup\u003ENot per protocol analysis. Clinically driven evaluation based on CEC adjudication of MI.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EReproduced with permission from JW Chambers, MD.\u003C\/p\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-10\u0022\u003EThe economic analysis compared OAS in elderly patients in the ORBIT II study (\u0026gt;\u200564 years; n\u2005=\u2005297) with standard treatment in Medicare patients (n\u2005=\u2005308) from hospitals reporting more than 10% of stent patients with calcification during the same time period. The baseline characteristics were comparable between these patient populations. The cost-model framework analysis revealed that the average projected cost offsets in the first year would fully cover the cost of OAS at $3795 and possibly extend to an additional $1118 in savings, yielding a total of $4913 in potential cost offset at 1 year. The incremental cost-effectiveness ratio (ICER) analysis demonstrated that OAS offered good value, with an ICER of $11\u2005895 per life-year gained, which was substantially below the \u201chigh value\u201d threshold of $50\u2005000 per quality-adjusted life-year.\u003C\/p\u003E\u003Cp id=\u0022p-11\u0022\u003EDr Chambers concluded that the ORBIT II study showed that coronary OAS is a safe and effective treatment option in complex patients with calcified coronary lesions that is also cost-effective and potentially cost saving.\u003C\/p\u003E\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\/10\/6.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?nzll01\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?nzll01\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}