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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\u003ECalcified coronary lesions are difficult to treat for several reasons. Researchers of the Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions trial [ORBIT II; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01092416\u0026amp;atom=%2Fspmdc%2F14%2F13%2F16.atom\u0022\u003ENCT01092416\u003C\/a\u003E] examined the safety and efficacy of the coronary Orbital Atherectomy System (OAS) to prepare de novo, severely calcified coronary lesions for enabling stent placement.\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\u003Ecardiology clinical trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ecoronary artery disease\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \n         \u003Cp id=\u0022p-2\u0022\u003ECalcified coronary lesions are difficult to treat for several reasons. They are prone to dissection of the arterial wall and can prevent adequate stent expansion. They are also difficult to dilate completely [Cavusoglu E et al. \u003Cem\u003ECatheter Cardiovasc Interv\u003C\/em\u003E 2004] and can preclude stent delivery to the desired location [Gilutz H et al. \u003Cem\u003ECatheter Cardiovasc Interv\u003C\/em\u003E 2000]. These factors result in poor clinical outcomes, including higher major adverse cardiac events (MACEs) and angiographic complications.\u003C\/p\u003E\n         \u003Cp id=\u0022p-3\u0022\u003EResearchers of the Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions trial [ORBIT II; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01092416\u0026amp;atom=%2Fspmdc%2F14%2F13%2F16.atom\u0022\u003ENCT01092416\u003C\/a\u003E], presented by Jeffrey Chambers, MD, Mercy Hospital, Minneapolis, Minnesota, USA, examined the safety and efficacy of the coronary Orbital Atherectomy System (OAS) to prepare de novo, severely calcified coronary lesions for enabling stent placement.\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003EThis prospective multicenter single-arm trial comprised 443 patients at 49 US sites. Inclusion criteria included fluoroscopic or intravascular ultrasound evidence of severe calcification in the target lesion, a target vessel reference diameter \u2265 2.5 mm and \u2264 4.0 mm, and target lesion length \u2264 40 mm. Almost 65% of the patients were male, and the mean age was 71.4 years. The efficacy end point was successful facilitation of stent deployment in severely calcified coronary lesions. Safety end points included cardiac death, target vessel revascularization, myocardial infarction, and MACE. The patients were followed for 1 year.\u003C\/p\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EStent implantation was successful in 97.7% of patients, with \u0026lt; 50% residual stenosis in 98.6% of patients. Low safety end point rates at 30 days and 1 year showed that the OAS was safe for treating de novo, severely calcified coronary lesions.\u003C\/p\u003E\n         \u003Cp id=\u0022p-6\u0022\u003EUnivariate analysis showed that only a history of coronary artery bypass graft was associated with an increased risk of MACE at 1 year (odds ratio, 1.89; 95% CI, 1.10 to 3.26; p = .0214). Safety comparisons with the ROTAXUS trial [Abdel-Wahab M et al. \u003Cem\u003EJACC Cardiovasc Interv\u003C\/em\u003E 2013] and the ACUITY and HORIZONS trials [Genereux P et al. \u003Cem\u003EJ Am Coll Cardiol\u003C\/em\u003E 2013] revealed lower rates of MACE, all-cause mortality, and target lesion revascularization in the ORBIT II trial [Chambers J, data on file at Cardiovascular Systems, Inc].\u003C\/p\u003E\n         \u003Cp id=\u0022p-7\u0022\u003EBased on both inpatient and outpatient procedures, mean costs were $3198 lower in ORBIT II patients compared with Medicare stent patients with calcified lesions (p = .003).\u003C\/p\u003E\n         \u003Cp id=\u0022p-8\u0022\u003EThe Diamondback Coronary OAS is the first Food and Drug Administration\u2013approved novel technology for treating patients with severely calcified coronary lesions. Dr. Chambers concluded that using the OAS for lesion preparation before stent implantation offers patients with severely calcified coronary lesions a new treatment option with potential cost benefits.\u003C\/p\u003E\n      \u003C\/div\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\/13\/16.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?nzoyzq\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}