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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\u003EDrug-coated balloons (DCB) offer homogeneous drug distribution to the vessel wall without the need for a permanent implant. This article discusses issues related to DCB development and evidence.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EThrombotic Disorders\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EDrug-coated balloons (DCB) offer homogeneous drug distribution to the vessel wall without the need for a permanent implant. Bruno Scheller, MD, Universit\u00e4tsklinikum des Saarlandes, Homburg\/Saar, Germany, discussed issues related to DCB development and evidence.\u003C\/p\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EEndovascular Indications\u003C\/h2\u003E\n         \u003Cp id=\u0022p-3\u0022\u003EIn the Local Taxane with Short Time Contact for Reduction of Restenosis in Distal Arteries [THUNDER; Tepe G et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2008] trial, patients with femoropopliteal artery stenosis or occlusion were randomly assigned to treatment with paclitaxel-coated balloons (n=48), uncoated balloons with paclitaxel in the contrast medium (n=52), or uncoated balloons without paclitaxel (control; n=54). Mean late lumen loss at 6 months was significantly lower in the paclitaxel-coated balloon group (0.4 mm) versus the control group (1.7 mm; p\u0026lt;0.001).\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003EIn five trials of DCB versus percutaneous transluminal angioplasty (PTA) in the superficial femoral artery (SFA), patients treated with DCB had significantly reduced restenosis at 6 and 12 months and clinical and functional benefit maintained up to 2 or more years [BIOLUX P-I, \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01221610\u0026amp;atom=%2Fspmdc%2F12%2F17%2F28.atom\u0022\u003ENCT01221610\u003C\/a\u003E; FEMPac, \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00472472\u0026amp;atom=%2Fspmdc%2F12%2F17%2F28.atom\u0022\u003ENCT00472472\u003C\/a\u003E; LEVANT I, \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00930813\u0026amp;atom=%2Fspmdc%2F12%2F17%2F28.atom\u0022\u003ENCT00930813\u003C\/a\u003E; PACIFIER, \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01083030\u0026amp;atom=%2Fspmdc%2F12%2F17%2F28.atom\u0022\u003ENCT01083030\u003C\/a\u003E; THUNDER, \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00156624\u0026amp;atom=%2Fspmdc%2F12%2F17%2F28.atom\u0022\u003ENCT00156624\u003C\/a\u003E]. A subanalysis of the Paclitaxel-coated Balloons in Femoral Indication to Defeat Restenosis [PACIFIER] trial showed that DCB benefited patients with de novo stenosis and total occlusion in the SFA, independent of lesion length [Werk M et al. \u003Cem\u003ECirc Cardiovasc Int\u003C\/em\u003E 2012. In press].\u003C\/p\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EA nonrandomized study of patients with below-the-knee (BTK) lesions \u223c17 to 18 cm long reported a restenosis rate after 3 months of 27.4% with DCB versus 69% with PTA [Schmidt A et al. \u003Cem\u003ECath Card\u003C\/em\u003E Int 2010; Schmidt A et al. \u003Cem\u003EJ Am Coll Cardiol\u003C\/em\u003E 2011]. The randomized Drug Eluting Balloon in Peripheral Intervention for Below the Knee Angioplasty Evaluation [DEBATE-BTK; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01558505\u0026amp;atom=%2Fspmdc%2F12%2F17%2F28.atom\u0022\u003ENCT01558505\u003C\/a\u003E] trial demonstrated significantly reduced 12-month restenosis and reocclusion with DCB versus conventional balloon angioplasty in patients with diabetes and critical limb ischemia [Liistro F et al. LINC 2012].\u003C\/p\u003E\n         \u003Cp id=\u0022p-6\u0022\u003EIn a nonrandomized series of patients with intracranial in-stent restenosis (ISR), high-grade restenosis rate occurred in 9% with DCB versus 50% with conventional balloon treatment [Vajda Z et al. \u003Cem\u003EAm J Neuroradiol\u003C\/em\u003E 2011]. In patients with arteriovenous fistulas, target lesion primary patency was 70% with DCB versus 25% with conventional balloon at 6 months (p\u0026lt;0.001) [Karnabatidis D. CIRSE 2011 Abstract 1905.3].\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-2\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003ECoronary Indications\u003C\/h2\u003E\n         \u003Cp id=\u0022p-7\u0022\u003ECompared with implantation of another DES, DCBs for coronary ISR may eliminate the need for a second or third stent, and reduce the need for prolonged dual antiplatelet therapy. Scheller et al. [\u003Cem\u003EN Engl J Med\u003C\/em\u003E 2006] found that in-segment late lumen loss in DES patients treated for ISR was 0.03 mm with DCB versus 0.74 mm with a conventional balloon. Follow-up to 6 years demonstrated reduced target lesion revascularization with DCB (9.3%) versus conventional balloon (38.9%; p=0.004) [Scheller B et al. \u003Cem\u003EJACC Cardiovasc Interv\u003C\/em\u003E 2012]. In patients with coronary ISR from a bare-metal stent (BMS), Unverdorben et al. [\u003Cem\u003ECirculation\u003C\/em\u003E 2009] reported reduced in-stent late loss (0.19 mm vs 0.45 mm; p=0.01), in-segment late loss (0.17 mm vs 0.38 mm; p=0.03), and in-segment restenosis (7.0% vs 20.3%; p=0.06) with DCB versus DES.\u003C\/p\u003E\n         \u003Cp id=\u0022p-8\u0022\u003EPatients with sirolimus-eluting ISR had significantly reduced restenosis (8.7% vs 62.5%; p=0.0001) with DCB versus a conventional balloon [Habara S et al. \u003Cem\u003EJACC Cardiovasc Interv\u003C\/em\u003E 2011]. The Paclitaxel-Eluting PTCA-Balloon Catheter to Treat Small Vessel Coronary Artery Disease [PEPCAD I; Unverdorben M et al. \u003Cem\u003EClin Res Cardiol\u003C\/em\u003E 2010] study in patients with de novo coronary lesions reported 6-month restenosis of \u223c5.5% with DCB and \u223c45% with DCB plus bare-metal stent (p=0.0001 for both).\u003C\/p\u003E\n         \u003Cp id=\u0022p-9\u0022\u003EThe German consensus group recommendations for DCB use are shown in \u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E [Kleber FX et al. \u003Cem\u003EEuroIntervention\u003C\/em\u003E 2011].\u003C\/p\u003E\n         \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\/12\/17\/28\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022German Consensus Group Recommendations for DCB Use.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1952025067\u0022 data-figure-caption=\u0022German Consensus Group Recommendations for DCB Use.\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\/12\/17\/28\/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\/12\/17\/28\/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\/12\/17\/28\/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\/15227\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 attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n               \u003Cp id=\u0022p-10\u0022 class=\u0022first-child\u0022\u003EGerman Consensus Group Recommendations for DCB Use.\u003C\/p\u003E\n            \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003ESource: Kleber FX et al. \u003Cem\u003EEuroIntervention\u003C\/em\u003E 2011.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-11\u0022\u003EDCBs can be used for a variety of endovascular and coronary indications. Results thus far have been promising for both endovascular therapy and treatment of ISR in the coronary bed. De novo disease is more of a challenge but trials are ongoing to clarify DCB use for this indication. Prof. Scheller said that DCBs are not a replacement for DES but may become an important new option in endovascular and coronary intervention. Compared with bioabsorbable stents, DCB have much better evidence from randomized clinical trials and large registries. However, both methods appear complementary toward the goal of avoiding permanent implants. According to Prof. Scheller, DCB and bioabsorbable stents represent technology for a new age of vascular therapy with the aim of leaving nothing behind.\u003C\/p\u003E\n      \u003C\/div\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\/17\/28.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?nzn7cb\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?nzn7cb\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}