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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\u003EA drug-eluting stent is a \u201ccombination product\u201d in which changes to one component may affect others; small alterations to strut thickness and geometry, polymer, drug, dose, and kinetics may result in big outcome changes, for better or worse. This article discusses the many factors involved in the development and deployment of novel stents.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EA drug-eluting stent (DES) is a \u201ccombination product\u201d in which changes to one component may affect others; small alterations to strut thickness and geometry, polymer, drug, dose, and kinetics may result in big outcome changes, for better or worse. Mitchell W. Krucoff, MD, Duke University Medical Center Durham, North Carolina, USA, discussed the many factors involved in the development and deployment of novel stents.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EAccording to Dr. Krucoff, the respective a priori and corollary rules for assessing breakthrough medical device technology are 1) the first generation is the worst generation; 2) just because a product is new does not prove that it is better; and 3) expect the unexpected.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EFor example, Daemen et al. [\u003Cem\u003ELancet\u003C\/em\u003E 2007] found that late stent thrombosis (beyond 30 days) was encountered at a steady rate over time, with no evidence of diminution up to 3 years of follow-up. Early and late stent thromboses were observed with sirolimus-eluting stents (SES; n=3823) and with paclitaxel-eluting stents (PES; n=4323). Acute coronary syndrome at presentation and diabetes were independent predictors of stent thrombosis.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EThe US Food and Drug Administration considers DES combination products with 3 components: stent platform design (ie, material composition, strut thickness, surface area, durability), polymer (ie, biocompatibility, consistency, durability), and drug (ie, dose, kinetics).\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EOrmiston et al. [\u003Cem\u003EJACC Cardiovasc Interv\u003C\/em\u003E 2011] undertook standardized bench-top compression and elongation testing to assess the longitudinal strength of contemporary stents. They found that a stent design change ensuring 3 connectors, especially at the proximal end of a stent, should increase longitudinal integrity but perhaps at the expense of stent flexibility.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EAlthough the polymer used in manufacturing has also been an issue, advances in polymer engineering now enable the production of DESs that are biocompatible, bioabsorbable, and have zero polymer. The Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects with De Novo Native Coronary Artery Lesions clinical trial [SPIRIT] evaluated the safety and efficacy of an everolimus stent versus a paclitaxel-eluting coronary stent. The primary outcome was ischemia-driven target lesion failure at 1 year. The authors found that the everolimus-eluting stent led to reduced rates of target lesion failure at 1 year compared with the PES. Results were consistent in all patients except those with diabetes [Stone GW et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2010].\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EKrucoff and colleagues [\u003Cem\u003EJACC Cardiovasc Interv\u003C\/em\u003E 2011] found similar results in the XIENCE V Everolimus Eluting Coronary Stent System Condition-of-Approval Post-Market [XIENCE V USA] study. There was a notable absence of stent thrombosis (ST) after dual antiplatelet therapy interruption beyond 6 months in standard- and high-risk patients.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EBased on these outcomes and other factors of importance in the design and development of DES, Dr. Krucoff concluded that engineering and design objectives are the key to better and safer DES; design endpoints range from procedural (deliverability) to biological (late loss, endothelialization) to clinical (angina, myocardial infarction, ST, death); design targets include novel aspects of stent platform, drug, and drug-delivery systems; and achieving novel design changes is not enough to claim noninferiority or superiority until clinical data confirm better outcomes.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2012 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\/12\/8\/24.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?nznakp\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}