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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 new generation of drug-eluting stent that is coated with biolimus and released from a biodegradable polymer demonstrated similar safety and efficacy through 9 months as compared with stents releasing sirolimus from a durable polymer in patients who were undergoing percutaneous coronary intervention, according to findings from the Limus Eluted from A Durable versus ERodable Stent [LEADERS] trial.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Einterventional techniques \u0026amp; devices clinical trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \n         \u003Cp id=\u0022p-2\u0022\u003EA new generation of drug-eluting stent that is coated with biolimus and released from a biodegradable polymer demonstrated similar safety and efficacy through 9 months as compared with stents releasing sirolimus from a durable polymer in patients who were undergoing percutaneous coronary intervention (PCI), according to findings from the LEADERS (Limus Eluted from A Durable versus ERodable Stent) trial. The biolimus stent may have the potential to minimize late complications related to the polymer component.\u003C\/p\u003E\n         \u003Cp id=\u0022p-3\u0022\u003EStephan Windecker, MD, Inselspital University Hospital, Bern, Switzerland, reported initial findings from the LEADERS trial, which were simultaneously published online in \u003Cem\u003EThe Lancet\u003C\/em\u003E [Windecker S et al. \u003Cem\u003ELancet\u003C\/em\u003E 2008].\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003EBiolimus is a highly lipophilic, semi-synthetic sirolimus analog that is immersed in a biodegradable polymer and applied only to the abluminal vessel side of the stent, thereby reducing the amount of drug that is released into the circulation. By 6 to 9 months following PCI, the polymer completely dissolves into carbon dioxide and water, leaving only the stainless steel stent in the affected vessel. This novel design escapes the durable polymer surface coatings of current drug-eluting stents, which have been implicated in delayed healing and late stent thrombosis.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-2\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EA \u201cReal-World\u201d Trial\u003C\/h2\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EIn the LEADERS trial (\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00389220\u0026amp;atom=%2Fspmdc%2F8%2F6%2F20.atom\u0022\u003ENCT00389220\u003C\/a\u003E), 1707 patients who were undergoing PCI were randomly assigned to receive a biolimus stent (n=857) or sirolimus stent (n=850). In a factorial design, 1 in 4 patients also was randomly selected for angiographic follow-up at 9 months.\u003C\/p\u003E\n         \u003Cp id=\u0022p-6\u0022\u003EIn an attempt to reflect routine clinical practice, the study design employed broad inclusion criteria and few exclusion criteria. Patients with stable coronary artery disease (CAD) or acute coronary syndrome (ACS) that presented as unstable angina, non-ST-elevation myocardial infarction (NSTEMI), or STEMI were enrolled. Patients had to have at least one lesion that had at least 50% diameter stenosis, but there were no limits on the lesion length or number of lesions or diseased vessels. Major exclusions included known allergy to standard antithrombotic agents, contrast, or stent material that was used in the study; elective surgery that required interruption of antiplatelet therapy; pregnancy; or participation in another trial.\u003C\/p\u003E\n         \u003Cp id=\u0022p-7\u0022\u003E\u201cLEADERS is the first all-comers study of PCI comparing two drug-eluting stents,\u201d said Laura Mauri, MD, MSc, Brigham and Women\u0027s Hospital, Boston, MA. With predominantly off-label and high-risk characteristics, the complex patient population includes diabetes mellitus in 24% of patients, multivessel stenting in 23%, and acute myocardial infarction (MI) in 34%. \u201cThis reflects the breadth of practice we see today and [permitted evaluation of] safety and efficacy across a broad population,\u201d Dr. Mauri said.\u003C\/p\u003E\n         \u003Cp id=\u0022p-8\u0022\u003EThe primary endpoint was the composite of cardiac death, MI, or clinically indicated target vessel revascularization (TVR) at 9 months. In those who were selected for angiographic evaluation (n=427), the primary endpoint was in-stent percent diameter stenosis as assessed by a blinded core laboratory.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-3\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003ENon-Inferior Efficacy and Safety\u003C\/h2\u003E\n         \u003Cp id=\u0022p-9\u0022\u003ENine months after PCI, a similar proportion of patients with biolimus-eluting stents and sirolimus-eluting stents reached the primary endpoint (9.2% vs 10.5%; RR=0.88; 95% CI, 0.64 to 1.19; p=0.003 for non-inferiority). Regarding individual safety and efficacy outcomes at 9 months, patients in the biolimus and sirolimus groups had similar rates of death (2.6% vs 2.8%; p=0.74), cardiac death (1.6% vs 2.5%; p=0.22), MI (5.7% vs 4.6%; p=0.30), and clinically indicated TVR (4.4% vs 5.5%; p=0.29) (p values for superiority).\u003C\/p\u003E\n         \u003Cp id=\u0022p-10\u0022\u003EThe cumulative rate of definite stent thrombosis (ST) at 9 months was 1.9% with biolimus versus 2.0% with sirolimus (RR=0.93; 95% CI, 0.47 to 1.85). The majority of ST events occurred during the first 30 days in both groups. A detailed analysis of definite, probable, and possible ST events over various time periods (0 to 30 days, 31 days to 9 months, 0 to 9 months) showed no differences between the stent groups.\u003C\/p\u003E\n         \u003Cp id=\u0022p-11\u0022\u003EIn subgroup analyses, the primary endpoint results were consistent across a broad range of patient characteristics and angiographic findings, including patients with diabetes mellitus; presentation with ACS; and presence of multivessel disease, de novo lesions, and small-vessel disease. The only exception was in the subgroup of STEMI patients (interaction p=0.02) who showed a treatment effect that favored biolimus (RR=0.37; 95% CI, 0.16 to 0.84), while patients without STEMI had equivalent risk, regardless of stent type (RR=1.03; 95% CI, 0.74 to 1.44).\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-4\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EComparable Angiographic Outcomes\u003C\/h2\u003E\n         \u003Cp id=\u0022p-12\u0022\u003EBiolimus stents also achieved the criteria for non-inferiority in the angiographic substudy with an in-stent diameter stenosis rate of 20.9% compared with 23.3% in the sirolimus group (p=0.001 for non-inferiority). No coronary aneurysms occurred in either stent group. Other angiographic outcomes, including in-stent percentage diameter stenosis, late loss, and binary restenosis, showed no significant differences between biolimus-eluting and sirolimus-eluting stents on superiority testing.\u003C\/p\u003E\n         \u003Cp id=\u0022p-13\u0022\u003EThe next question is whether biolimus-eluting stents can improve long-term safety. In the ongoing follow-up of the LEADERS trial, the secondary endpoints are scheduled for annual re-evaluation beginning at Year 1 and continuing through Year 5; however, a larger trial would be required to assess for superiority of the biolimus stent.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2008 MD Conference Express\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\/8\/6\/20.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?nzmd0d\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}