Current State of Bioabsorbable Polymer-Coated Drug-Eluting Stents
Identifieur interne : 001297 ( Pmc/Curation ); précédent : 001296; suivant : 001298Current State of Bioabsorbable Polymer-Coated Drug-Eluting Stents
Auteurs : Abhilash Akinapelli [États-Unis] ; Jack P. Chen [États-Unis] ; Kristine Roy [États-Unis] ; Joseph Donnelly [États-Unis] ; Keith Dawkins [États-Unis] ; Barbara Huibregtse [États-Unis] ; Dongming Hou [États-Unis]Source :
- Current Cardiology Reviews [ 1573-403X ] ; 2017.
Abstract
Drug-eluting stents (DES) have been shown to significantly reduce clinical and angiograph-ic restenosis compared to bare metal stents (BMS). The polymer coatings on DES elute antiproliferative drugs to inhibit intimal proliferation and prevent restenosis after stent implantation. Permanent poly-mers which do not degrade in vivo may increase the likelihood of stent-related delayed arterial healing or polymer hypersensitivity. In turn, these limitations may contribute to an increased risk of late clinical events. Intuitively, a polymer which degrades after completion of drug release, leaving an inert metal scaffold in place, may improve arterial healing by removing a chronic source of inflammation, neoath-erosclerosis, and/or late thrombosis. In this way, a biodegradable polymer may reduce late ischemic events. Additionally, improved healing after stent implantation could reduce the requirement for long-term dual antiplatelet therapy and the associated risk of bleeding and cost. This review will focus on bioabsorbable polymer-coated DES currently being evaluated in clinical trials.
Url:
DOI: 10.2174/1573403X12666161222155230
PubMed: 28017123
PubMed Central: 5452149
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Chen</name><affiliation wicri:level="1"><nlm:aff id="aff2">Northside Hospital, Atlanta, GA,<country>USA</country>;</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Roy, Kristine" sort="Roy, Kristine" uniqKey="Roy K" first="Kristine" last="Roy">Kristine Roy</name><affiliation wicri:level="1"><nlm:aff id="aff3">Boston Scientific, Marlborough, MA,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Donnelly, Joseph" sort="Donnelly, Joseph" uniqKey="Donnelly J" first="Joseph" last="Donnelly">Joseph Donnelly</name><affiliation wicri:level="1"><nlm:aff id="aff3">Boston Scientific, Marlborough, MA,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Dawkins, Keith" sort="Dawkins, Keith" uniqKey="Dawkins K" first="Keith" last="Dawkins">Keith Dawkins</name><affiliation wicri:level="1"><nlm:aff id="aff3">Boston Scientific, Marlborough, MA,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Huibregtse, Barbara" sort="Huibregtse, Barbara" uniqKey="Huibregtse B" first="Barbara" last="Huibregtse">Barbara Huibregtse</name><affiliation wicri:level="1"><nlm:aff id="aff3">Boston Scientific, Marlborough, MA,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Hou, Dongming" sort="Hou, Dongming" uniqKey="Hou D" first="Dongming" last="Hou">Dongming Hou</name><affiliation wicri:level="1"><nlm:aff id="aff3">Boston Scientific, Marlborough, MA,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></analytic><series><title level="j">Current Cardiology Reviews</title><idno type="ISSN">1573-403X</idno><idno type="eISSN">1875-6557</idno><imprint><date when="2017">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>Drug-eluting stents (DES) have been shown to significantly reduce clinical and angiograph-ic restenosis compared to bare metal stents (BMS). The polymer coatings on DES elute antiproliferative drugs to inhibit intimal proliferation and prevent restenosis after stent implantation. Permanent poly-mers which do not degrade in vivo may increase the likelihood of stent-related delayed arterial healing or polymer hypersensitivity. In turn, these limitations may contribute to an increased risk of late clinical events. Intuitively, a polymer which degrades after completion of drug release, leaving an inert metal scaffold in place, may improve arterial healing by removing a chronic source of inflammation, neoath-erosclerosis, and/or late thrombosis. In this way, a biodegradable polymer may reduce late ischemic events. Additionally, improved healing after stent implantation could reduce the requirement for long-term dual antiplatelet therapy and the associated risk of bleeding and cost. 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Curr Cardiol Rev</journal-id><journal-id journal-id-type="iso-abbrev">Curr Cardiol Rev</journal-id><journal-id journal-id-type="publisher-id">CCR</journal-id><journal-title-group><journal-title>Current Cardiology Reviews</journal-title></journal-title-group><issn pub-type="ppub">1573-403X</issn><issn pub-type="epub">1875-6557</issn><publisher><publisher-name>Bentham Science Publishers</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">28017123</article-id><article-id pub-id-type="pmc">5452149</article-id><article-id pub-id-type="publisher-id">CCR-13-139</article-id><article-id pub-id-type="doi">10.2174/1573403X12666161222155230</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>Current State of Bioabsorbable Polymer-Coated Drug-Eluting Stents</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Akinapelli</surname><given-names>Abhilash</given-names></name><xref ref-type="aff" rid="aff1">1</xref></contrib><contrib contrib-type="author"><name><surname>Chen</surname><given-names>Jack P.</given-names></name><xref ref-type="aff" rid="aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Roy</surname><given-names>Kristine</given-names></name><xref ref-type="aff" rid="aff3">3</xref></contrib><contrib contrib-type="author"><name><surname>Donnelly</surname><given-names>Joseph</given-names></name><xref ref-type="aff" rid="aff3">3</xref></contrib><contrib contrib-type="author"><name><surname>Dawkins</surname><given-names>Keith</given-names></name><xref ref-type="aff" rid="aff3">3</xref></contrib><contrib contrib-type="author"><name><surname>Huibregtse</surname><given-names>Barbara</given-names></name><xref ref-type="aff" rid="aff3">3</xref></contrib><contrib contrib-type="author"><name><surname>Hou</surname><given-names>Dongming</given-names></name><xref ref-type="aff" rid="aff3">3</xref><xref ref-type="corresp" rid="cor1">*</xref></contrib><aff id="aff1"><label>1</label>Creighton University Medical Center, Omaha, NE,<country>USA</country>;</aff><aff id="aff2"><label>2</label>Northside Hospital, Atlanta, GA,<country>USA</country>;</aff><aff id="aff3"><label>3</label>Boston Scientific, Marlborough, MA,<country>USA</country></aff></contrib-group><author-notes><corresp id="cor1"><label>*</label>Address correspondence to this author at the One Scimed Pl., A300, Maple Grove, MN 55311, USA; Tel: 763-203-0606;, E-mail: <email xlink:href="Dongming.Hou@bsci.com">Dongming.Hou@bsci.com</email></corresp></author-notes><pub-date pub-type="ppub"><month>5</month><year>2017</year></pub-date><pub-date pub-type="epub"><month>5</month><year>2017</year></pub-date><volume>13</volume><issue>2</issue><fpage>139</fpage><lpage>154</lpage><history><date date-type="received"><day>18</day><month>8</month><year>2016</year></date><date date-type="rev-recd"><day>06</day><month>10</month><year>2016</year></date><date date-type="accepted"><day>18</day><month>10</month><year>2016</year></date></history><permissions><copyright-statement>© 2017 Bentham Science Publishers</copyright-statement><copyright-year>2017</copyright-year><license license-type="open-access" xlink:href="https://creativecommons.org/licenses/by-nc/4.0/legalcode"><license-p>This is an open access article licensed under the terms of the Creative Commons Attribution-Non-Commercial 4.0 International Public License (CC BY-NC 4.0) <uri xlink:type="simple" xlink:href="https://creativecommons.org/licenses/by-nc/4.0/legalcode">(https://creativecommons.org/licenses/by-nc/4.0/legalcode</uri>), which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.</license-p></license></permissions><abstract><p>Drug-eluting stents (DES) have been shown to significantly reduce clinical and angiograph-ic restenosis compared to bare metal stents (BMS). The polymer coatings on DES elute antiproliferative drugs to inhibit intimal proliferation and prevent restenosis after stent implantation. Permanent poly-mers which do not degrade in vivo may increase the likelihood of stent-related delayed arterial healing or polymer hypersensitivity. In turn, these limitations may contribute to an increased risk of late clinical events. Intuitively, a polymer which degrades after completion of drug release, leaving an inert metal scaffold in place, may improve arterial healing by removing a chronic source of inflammation, neoath-erosclerosis, and/or late thrombosis. In this way, a biodegradable polymer may reduce late ischemic events. Additionally, improved healing after stent implantation could reduce the requirement for long-term dual antiplatelet therapy and the associated risk of bleeding and cost. This review will focus on bioabsorbable polymer-coated DES currently being evaluated in clinical trials.</p></abstract><kwd-group kwd-group-type="author"><title>Keywords: </title><kwd>Bioabsorbable polymer</kwd><kwd>drug-eluting stent</kwd><kwd>abluminal coating</kwd><kwd>BMS</kwd><kwd>clinical trials</kwd></kwd-group></article-meta></front><floats-group><fig id="F1" fig-type="figure" position="float"><label>Fig. (1)</label><caption><p>Time Course For Polymer Bioabsorption.</p></caption><graphic xlink:href="CCR-13-139_F1"></graphic></fig><fig id="F2" fig-type="figure" position="float"><label>Fig. (1)</label><caption><p>Time Course For Polymer Bioabsorption.</p></caption><graphic xlink:href="CCR-13-139_F2"></graphic></fig><table-wrap id="T1" position="float"><label>Table 1</label><caption><p>Current bioabsorbable-polymer coated drug-eluting stents tested in clinical trials.</p></caption><table frame="border" rules="all" width="100%"><thead><tr><th valign="top" align="center" scope="col" rowspan="1" colspan="1"><bold>Name</bold></th><th valign="top" align="center" scope="col" rowspan="1" colspan="1"><bold>Company</bold></th><th valign="top" align="center" scope="col" rowspan="1" colspan="1"><bold>Platform</bold></th><th valign="top" align="center" scope="col" rowspan="1" colspan="1"><bold>Thickness (µm)</bold></th><th valign="top" align="center" scope="col" rowspan="1" colspan="1"><bold>Polymer</bold></th><th valign="top" align="center" scope="col" rowspan="1" colspan="1"><bold>Polymer Distribution/ Thickness</bold></th><th valign="top" align="center" scope="col" rowspan="1" colspan="1"><bold>Drug</bold></th><th valign="top" align="center" scope="col" rowspan="1" colspan="1"><bold>Drug Release/</bold><break></break><bold>Polymer Absorption</bold></th></tr></thead><tbody><tr><td valign="top" align="center" scope="row" rowspan="1" colspan="1">Biomatrix [<xref rid="r49" ref-type="bibr">49</xref>]</td><td valign="top" align="center" rowspan="1" colspan="1">Biosensors</td><td valign="top" align="center" rowspan="1" colspan="1">Stainless Steel</td><td valign="top" align="center" rowspan="1" colspan="1">120</td><td valign="top" align="center" rowspan="1" colspan="1">Polylactic acid</td><td valign="top" align="center" rowspan="1" colspan="1">Abluminal/10 µm</td><td valign="top" align="center" rowspan="1" colspan="1">Biolimus A9</td><td valign="top" align="center" rowspan="1" colspan="1">6 mo/9 mo</td></tr><tr><td valign="top" align="center" scope="row" rowspan="1" colspan="1">Nobori [<xref rid="r53" ref-type="bibr">53</xref>]</td><td valign="top" align="center" rowspan="1" colspan="1">Terumo</td><td valign="top" align="center" rowspan="1" colspan="1">Stainless Steel</td><td valign="top" align="center" rowspan="1" colspan="1">125</td><td valign="top" align="center" rowspan="1" colspan="1">Polylactic acid</td><td valign="top" align="center" rowspan="1" colspan="1">Abluminal/20 µm</td><td valign="top" align="center" rowspan="1" colspan="1">Biolimus A9</td><td valign="top" align="center" rowspan="1" colspan="1">6 mo/9 mo</td></tr><tr><td valign="top" align="center" scope="row" rowspan="1" colspan="1">Ultimaster [<xref rid="r65" ref-type="bibr">65</xref>]</td><td valign="top" align="center" rowspan="1" colspan="1">Terumo</td><td valign="top" align="center" rowspan="1" colspan="1">Cobalt <break></break>Chromium</td><td valign="top" align="center" rowspan="1" colspan="1">80</td><td valign="top" align="center" rowspan="1" colspan="1">Poly (DL-lactide-co-caprolactone)</td><td valign="top" align="center" rowspan="1" colspan="1">Abluminal/15 µm</td><td valign="top" align="center" rowspan="1" colspan="1">Sirolimus</td><td valign="top" align="center" rowspan="1" colspan="1">For both 3-4 mo</td></tr><tr><td valign="top" align="center" scope="row" rowspan="1" colspan="1">SYNERGY [<xref rid="r41" ref-type="bibr">41</xref>]</td><td valign="top" align="center" rowspan="1" colspan="1">Boston Scientific</td><td valign="top" align="center" rowspan="1" colspan="1">Platinum <break></break>chromium</td><td valign="top" align="center" rowspan="1" colspan="1">74</td><td valign="top" align="center" rowspan="1" colspan="1">Polylactic co-glycolic acid</td><td valign="top" align="center" rowspan="1" colspan="1">Abluminal/4 µm</td><td valign="top" align="center" rowspan="1" colspan="1">Everolimus</td><td valign="top" align="center" rowspan="1" colspan="1">3 mo/4 mo</td></tr><tr><td valign="top" align="center" scope="row" rowspan="1" colspan="1">Orsiro [<xref rid="r114" ref-type="bibr">114</xref>]</td><td valign="top" align="center" rowspan="1" colspan="1">Biotronik</td><td valign="top" align="center" rowspan="1" colspan="1">Cobalt <break></break>chromium</td><td valign="top" align="center" rowspan="1" colspan="1">61</td><td valign="top" align="center" rowspan="1" colspan="1">Poly L lactic acid</td><td valign="top" align="center" rowspan="1" colspan="1">Conformal/up to 7.5µm</td><td valign="top" align="center" rowspan="1" colspan="1">Sirolimus</td><td valign="top" align="center" rowspan="1" colspan="1">3 mo/15 mo</td></tr><tr><td valign="top" align="center" scope="row" rowspan="1" colspan="1">MiStent [<xref rid="r75" ref-type="bibr">75</xref>]</td><td valign="top" align="center" rowspan="1" colspan="1">Micell</td><td valign="top" align="center" rowspan="1" colspan="1">Cobalt <break></break>Chromium</td><td valign="top" align="center" rowspan="1" colspan="1">64</td><td valign="top" align="center" rowspan="1" colspan="1">Polylactic co-glycolic acid</td><td valign="top" align="center" rowspan="1" colspan="1">Conformal/Not reported</td><td valign="top" align="center" rowspan="1" colspan="1">Crystalline sirolimus</td><td valign="top" align="center" rowspan="1" colspan="1">9 mo/3 mo</td></tr><tr><td valign="top" align="center" scope="row" rowspan="1" colspan="1">DESyne BD [<xref rid="r78" ref-type="bibr">78</xref>]</td><td valign="top" align="center" rowspan="1" colspan="1">Elixir Medical Corporation</td><td valign="top" align="center" rowspan="1" colspan="1">Cobalt <break></break>chromium</td><td valign="top" align="center" rowspan="1" colspan="1">81</td><td valign="top" align="center" rowspan="1" colspan="1">Poly L Lactide (PLLA)-based polymer</td><td valign="top" align="center" rowspan="1" colspan="1">Conformal/<3 µm</td><td valign="top" align="center" rowspan="1" colspan="1">Novolimus</td><td valign="top" align="center" rowspan="1" colspan="1">3 mo/9 mo</td></tr><tr><td valign="top" align="center" scope="row" rowspan="1" colspan="1">TIVOLI [<xref rid="r81" ref-type="bibr">81</xref>]</td><td valign="top" align="center" rowspan="1" colspan="1">Essen Tech</td><td valign="top" align="center" rowspan="1" colspan="1">Cobalt <break></break>chromium</td><td valign="top" align="center" rowspan="1" colspan="1">80</td><td valign="top" align="center" rowspan="1" colspan="1">Polylactic co-glycolic acid</td><td valign="top" align="center" rowspan="1" colspan="1">5.5 µm</td><td valign="top" align="center" rowspan="1" colspan="1">Sirolimus</td><td valign="top" align="center" rowspan="1" colspan="1">80% by 1 mo/3-6 mo</td></tr><tr><td valign="top" align="center" scope="row" rowspan="1" colspan="1">EXCEL [<xref rid="r82" ref-type="bibr">82</xref>]</td><td valign="top" align="center" rowspan="1" colspan="1">JW Medical Systems</td><td valign="top" align="center" rowspan="1" colspan="1">Stainless steel</td><td valign="top" align="center" rowspan="1" colspan="1">119</td><td valign="top" align="center" rowspan="1" colspan="1">Polylactic acid</td><td valign="top" align="center" rowspan="1" colspan="1">10-15 µm</td><td valign="top" align="center" rowspan="1" colspan="1">Sirolimus</td><td valign="top" align="center" rowspan="1" colspan="1">6 mo/6-9 mo</td></tr><tr><td valign="top" align="center" scope="row" rowspan="1" colspan="1">EXCEL II [<xref rid="r85" ref-type="bibr">85</xref>]</td><td valign="top" align="center" rowspan="1" colspan="1">JW Medical Systems</td><td valign="top" align="center" rowspan="1" colspan="1">Cobalt <break></break>chromium</td><td valign="top" align="center" rowspan="1" colspan="1">88</td><td valign="top" align="center" rowspan="1" colspan="1">Polylactic acid</td><td valign="top" align="center" rowspan="1" colspan="1">4 µm</td><td valign="top" align="center" rowspan="1" colspan="1">Sirolimus</td><td valign="top" align="center" rowspan="1" colspan="1">NR/6-9 mo</td></tr><tr><td valign="top" align="center" scope="row" rowspan="1" colspan="1">Inspiron [<xref rid="r86" ref-type="bibr">86</xref>]</td><td valign="top" align="center" rowspan="1" colspan="1">Scitech</td><td valign="top" align="center" rowspan="1" colspan="1">Cobalt <break></break>chromium</td><td valign="top" align="center" rowspan="1" colspan="1">75</td><td valign="top" align="center" rowspan="1" colspan="1">Polylactic acid + Polylactic co-glycolic acid</td><td valign="top" align="center" rowspan="1" colspan="1">Abluminal/5 µm</td><td valign="top" align="center" rowspan="1" colspan="1">Sirolimus</td><td valign="top" align="center" rowspan="1" colspan="1">80% by 1 mo/6-9 mo</td></tr><tr><td valign="top" align="center" scope="row" rowspan="1" colspan="1">Firehawk [<xref rid="r95" ref-type="bibr">95</xref>]</td><td valign="top" align="center" rowspan="1" colspan="1">Microport Medical</td><td valign="top" align="center" rowspan="1" colspan="1">Cobalt <break></break>chromium</td><td valign="top" align="center" rowspan="1" colspan="1">86</td><td valign="top" align="center" rowspan="1" colspan="1">Polylactic acid</td><td valign="top" align="center" rowspan="1" colspan="1">Abluminal</td><td valign="top" align="center" rowspan="1" colspan="1">Sirolimus</td><td valign="top" align="center" rowspan="1" colspan="1">3 mo/9 mo</td></tr><tr><td valign="top" align="center" scope="row" rowspan="1" colspan="1">Yukon Choice Flex [<xref rid="r100" ref-type="bibr">100</xref>]</td><td valign="top" align="center" rowspan="1" colspan="1">Translumina GmbH</td><td valign="top" align="center" rowspan="1" colspan="1">Stainless Steel</td><td valign="top" align="center" rowspan="1" colspan="1">79</td><td valign="top" align="center" rowspan="1" colspan="1">Polylactic acid</td><td valign="top" align="center" rowspan="1" colspan="1">Abluminal/Not reported</td><td valign="top" align="center" rowspan="1" colspan="1">Sirolimus</td><td valign="top" align="center" rowspan="1" colspan="1">4 wk/ 6-9 mo</td></tr><tr><td valign="top" align="center" scope="row" rowspan="1" colspan="1">BuMA [<xref rid="r102" ref-type="bibr">102</xref>]</td><td valign="top" align="center" rowspan="1" colspan="1">Sino Medical</td><td valign="top" align="center" rowspan="1" colspan="1">Stainless Steel</td><td valign="top" align="center" rowspan="1" colspan="1">100-110</td><td valign="top" align="center" rowspan="1" colspan="1">Polylactic co-glycolic acid</td><td valign="top" align="center" rowspan="1" colspan="1">Conformal/10 µm</td><td valign="top" align="center" rowspan="1" colspan="1">Sirolimus</td><td valign="top" align="center" rowspan="1" colspan="1">30 d/2-3 mo</td></tr><tr><td valign="top" align="center" scope="row" rowspan="1" colspan="1">Svelte [<xref rid="r105" ref-type="bibr">105</xref>]</td><td valign="top" align="center" rowspan="1" colspan="1">Svelte Medical Systems</td><td valign="top" align="center" rowspan="1" colspan="1">Cobalt <break></break>chromium</td><td valign="top" align="center" rowspan="1" colspan="1">81</td><td valign="top" align="center" rowspan="1" colspan="1">Poly(ester amide)</td><td valign="top" align="center" rowspan="1" colspan="1">Conformal/6 µm</td><td valign="top" align="center" rowspan="1" colspan="1">Sirolimus</td><td valign="top" align="center" rowspan="1" colspan="1">2 mo/12 mo</td></tr><tr><td valign="top" align="center" scope="row" rowspan="1" colspan="1">BioMime [<xref rid="r106" ref-type="bibr">106</xref>]</td><td valign="top" align="center" rowspan="1" colspan="1">Meril Life Sciences</td><td valign="top" align="center" rowspan="1" colspan="1">Cobalt <break></break>chromium</td><td valign="top" align="center" rowspan="1" colspan="1">65</td><td valign="top" align="center" rowspan="1" colspan="1">PLLA+PLGA</td><td valign="top" align="center" rowspan="1" colspan="1">Conformal/2 µm</td><td valign="top" align="center" rowspan="1" colspan="1">Sirolimus</td><td valign="top" align="center" rowspan="1" colspan="1">75% in 15 d/60 d</td></tr></tbody></table></table-wrap><table-wrap id="T2" position="float"><label>Table 2</label><caption><p>Summary of clinical trials for the SYNERGY everolimus-eluting bioabsorbable polymer stent.</p></caption><table frame="border" rules="all" width="100%"><thead><tr><th valign="top" align="center" scope="col" rowspan="1" colspan="1"><bold>Trial</bold></th><th valign="top" align="center" scope="col" rowspan="1" colspan="1"><bold>Control</bold></th><th valign="top" align="center" scope="col" rowspan="1" colspan="1"><bold># of patients/study design</bold></th><th valign="top" align="center" scope="col" rowspan="1" colspan="1"><bold>Results</bold></th></tr></thead><tbody><tr><td valign="top" align="left" scope="row" rowspan="1" colspan="1">EVOLVE<break></break>6-months [<xref rid="r39" ref-type="bibr">39</xref>]<break></break>5-year [<xref rid="r40" ref-type="bibr">40</xref>]<break></break>NCT01135225</td><td valign="top" align="left" rowspan="1" colspan="1">EES</td><td valign="top" align="left" rowspan="1" colspan="1">N=291; Prospective, multisite, randomized (1:1:1), single-blind, noninferiority; 29 sites (Europe, Australia, New Zealand,) Single target lesion ≤28mm, ≥2.25 to ≤3.5 mm RVD</td><td valign="top" align="left" rowspan="1" colspan="1"><bold>Clinical 1° endpoint:</bold> 30-d TLF EES 0 (0%), SYNERGY 1(1.1%), and SYNERGY ½ Dose 3 (3.1%); SYNERGY vs EES <italic>P</italic>=0.49 and SYNERGY ½ dose vs EES <italic>P</italic>=0.25, respectively<break></break><bold>Angiographic 1° Endpoint:</bold> 6 m in-stent late loss in EES 0.15±0.34 mm; SYNERGY (0.10±0.25 mm) and SYNERGY ½ Dose group (0.13±0.26 mm) were both noninferior to EES; <italic>P</italic><sub>noninferiority</sub><0.001)<break></break><bold>2° endpoints:</bold><break></break>• At 5 years, rates of cardiac death, MI, TVR, TLR, TLF, and TVF remained low and not significantly different between treatment groups; no incidence of definite/probable ST in any treatment group</td></tr><tr><td valign="top" align="left" scope="row" rowspan="1" colspan="1">EVOLVE II<break></break>1 year [<xref rid="r41" ref-type="bibr">41</xref>]<break></break>2 years [<xref rid="r42" ref-type="bibr">42</xref>]<break></break>EVOLVE II Diabetes [<xref rid="r43" ref-type="bibr">43</xref>, <xref rid="r44" ref-type="bibr">44</xref>] NCT01665053</td><td valign="top" align="left" rowspan="1" colspan="1">EES</td><td valign="top" align="left" rowspan="1" colspan="1">N=1684; Prospective, multisite, single-blind, randomized (1:1) noninferiority; 125 sites (US, Canada, Europe, Australia, New Zealand, Singapore, and Japan); ≤3 target lesions ≤34mm, ≥2.25 to ≤4.0 mm RVD</td><td valign="top" align="left" rowspan="1" colspan="1"><bold>1° endpoint:</bold> 12 m TLF was 6.5% of EES and 6.7% SYNERGY treated subjects (ITT: 97.5% upper confidence bound=2.68%; <italic>P<sub>noninferiority</sub></italic>=0.0005; Per Protocol: TLF EES 6.4%, 6.4% SYNERGY, 97.5% upper confidence bound=2.51%; <italic>P<sub>noninferiority</sub></italic> =0.0003)<break></break><bold>2° endpoints:</bold><break></break>At 2 years, cardiac death (EES 1.5% vs SYNERGY 1.0%; <italic>P</italic>=0.35), MI (5.4% vs 5.5% based on 3x CK-MB ULN; <italic>P</italic>=0.89), TLR (3.1% vs 4.3%; <italic>P</italic>=0.17), or ST (0. 8% vs 0.4%; <italic>P</italic>=0.31).<break></break><bold>Diabetes Substudy:</bold><break></break><bold>1° endpoint</bold>: 12 m TLF occurred in 7.5% of SYNERGY-treated patients with diabetes, significantly less than the performance goal (<italic>P</italic><0.0001). The 2-year rate of TLF was 11.2% and definite/probable ST occurred in 1.1% of patients.</td></tr><tr><td valign="top" align="left" scope="row" rowspan="1" colspan="1">EVOLVE II QCA<break></break>12-month [<xref rid="r45" ref-type="bibr">45</xref>]<break></break>NCT01787799</td><td valign="top" align="left" rowspan="1" colspan="1">N/A</td><td valign="top" align="left" rowspan="1" colspan="1">N=100; Prospective, multisite, single-arm; 12 sites (Australia, New Zealand, Singapore, and Japan) ; ≤3 target lesions ≤34mm, ≥2.25 to ≤4.0 mm RVD</td><td valign="top" align="left" rowspan="1" colspan="1"><bold>1° endpoint:</bold> 9 m in-stent late loss 0.23 mm (1-sided 97.5% upper confidence bound 0.40 mm), and was significantly below the prespecified performance goal of 0.4 mm (<italic>P</italic><0.0001).<break></break>Post-procedure incomplete stent apposition was also low (2.1%), and 9-month % volume obstruction by IVUS was 5.2%. At 12 m follow-up, there were no deaths or ST. Five patients had peri-procedural non-Q wave MI (based on CK-MB>3x upper limit of normal), and 1 TLR.</td></tr><tr><td valign="top" align="left" scope="row" rowspan="1" colspan="1">EVOLVE China<break></break>12-month [<xref rid="r115" ref-type="bibr">115</xref>]<break></break>NCT01966159</td><td valign="top" align="left" rowspan="1" colspan="1">EES</td><td valign="top" align="left" rowspan="1" colspan="1">N=412; Prospective, multisite, single-blind, randomized (1:1) noninferiority; 14 sites in China; ≤2 target lesions ≤34mm, ≥2.25 to ≤4.0 mm RVD</td><td valign="top" align="left" rowspan="1" colspan="1"><bold>1° endpoint</bold>: 9 m in stent late loss (SYNERGY 0.20mm±0.33mm vs EES 0.17mm± 0.37mm). The upper 1-sided 97.3% confidence interval of the difference (0.10 mm) was significantly less than the noninferiority margin of 0.15 mm (<italic>P</italic><0.0008).<break></break>Clinical adverse event rates were low and not significantly different at 12 months (all <italic>P</italic>>0.05).</td></tr></tbody></table><table-wrap-foot><p>Abbreviations: CAD = coronary artery disease; EES = everolimus-eluting stents; IVUS = intravascular ultrasound; MI = myocardial infarction; RVD = reference vessel diameter; TLF = target lesion failure; TLR = target lesion revascularization; TVR = target-vessel revascularization; ST = stent thrombosis.</p></table-wrap-foot></table-wrap><table-wrap id="T3" position="float"><label>Table 3</label><caption><p>Summary of clinical trials for the Biomatrix biolimus-eluting bioabsorbable polymer stent.</p></caption><table frame="border" rules="all" width="100%"><thead><tr><th valign="top" align="center" scope="col" rowspan="1" colspan="1"><bold>Trial</bold></th><th valign="top" align="center" scope="col" rowspan="1" colspan="1"><bold>Control</bold></th><th valign="top" align="center" scope="col" rowspan="1" colspan="1"><bold># of patients/study design</bold></th><th valign="top" align="center" scope="col" rowspan="1" colspan="1"><bold>Results</bold></th></tr></thead><tbody><tr><td valign="top" align="left" scope="row" rowspan="1" colspan="1">STEALTH 6-month results (2005) [<xref rid="r116" ref-type="bibr">116</xref>]</td><td valign="top" align="left" rowspan="1" colspan="1">BMS</td><td valign="top" align="left" rowspan="1" colspan="1">D<italic>e novo</italic> coronary lesions <24mm in length, diameter ≥2.7mm to ≤3.7mm<break></break>120 patients randomized 2:1; double-blind; multicenter</td><td valign="top" align="left" rowspan="1" colspan="1"><bold>1° endpoint:</bold> LLL at 6 months: Biomatrix 0.14mm±0.45mm vs BMS 0.40mm±0.41mm; <italic>P</italic>=0.004<break></break><bold>2° endpoint:</bold> Similar event free survival (Biomatix 96.3% vs BMS 97.5%; <italic>P</italic>=0.72) and TLR (Biomatix 3.9% vs BMS 7.7%; <italic>P</italic>=NS) in both groups</td></tr><tr><td valign="top" align="left" scope="row" rowspan="1" colspan="1">LEADERS 9-month results(2008) [<xref rid="r49" ref-type="bibr">49</xref>];<break></break>LEADERS 5-year results (2013) [<xref rid="r50" ref-type="bibr">50</xref>]<break></break>NCT00389220</td><td valign="top" align="left" rowspan="1" colspan="1">SES</td><td valign="top" align="left" rowspan="1" colspan="1">Patients with chronic, stable CAD or ACS; RVD 2.25mm to 3.5mm<break></break>1,707 patients randomized 1:1; multicenter; noninferiority</td><td valign="top" align="left" rowspan="1" colspan="1"><bold>1° endpoint:</bold> MACE at 9 months: Biomatrix 9% vs SES 11%; <italic>P</italic><sub>noninferiority</sub>=0.003, <italic>P</italic><sub>superiority</sub>=0.39)<break></break><bold>2° endpoints:</bold><break></break>9-month in-stent %DS Biomatrix 20.9% vs SES 23.3%; <italic>P</italic><sub>noninferiority</sub>=0.001, <italic>P</italic><sub>superiority</sub>=0.26)<break></break>5-year MACE Biomatrix 22.3% vs SES 26.1%; <italic>P</italic><sub>noninferiority</sub><0.0001, <italic>P</italic><sub>superiority</sub>=0.07)<break></break>Very late definite ST (1 to 5 years): Biomatrix 0.7% vs SES 2.5%; RR: 0.26 [CI: 0.10 to 0.68], <italic>P</italic>=0.003)</td></tr><tr><td valign="top" align="left" scope="row" rowspan="1" colspan="1">COMFORTABLE<break></break>1-year results (2012) [<xref rid="r51" ref-type="bibr">51</xref>]; 2-year follow-up (2014) [<xref rid="r52" ref-type="bibr">52</xref>]<break></break>NCT00962416</td><td valign="top" align="left" rowspan="1" colspan="1">BMS</td><td valign="top" align="left" rowspan="1" colspan="1">1,161 patients with STEMI randomized 1:1; multicenter</td><td valign="top" align="left" rowspan="1" colspan="1"><bold>1° endpoint:</bold> 1-year MACE: Biomatrix 4.3% vs BMS 8.7%; <italic>P</italic>=0.004<break></break><bold>2° endpoints:</bold><break></break>1-year Definite ST with Biomatrix 0.9% vs BMS 2.1%; <italic>P=</italic>0 .10<break></break>13-month in-stent %DS Biomatrix 12.0mm±7.2mm vs BMS 39.6mm±25.2mm; <italic>P</italic><0.001<break></break>2-year MACE Biomatrix 5.8% vs BMS 11.9%; <italic>P</italic><0.001</td></tr><tr><td valign="top" align="left" scope="row" rowspan="1" colspan="1">e-Biomatrix Registry<break></break>[<xref rid="r117" ref-type="bibr">117</xref>]<break></break>NCT01289002 and NCT01254487</td><td valign="top" align="left" rowspan="1" colspan="1">N/A</td><td valign="top" align="left" rowspan="1" colspan="1">Consists of 2 registries: e-BioMatrix PMS N= 1,106 patients; and e-BioMatrix PMR N=4,453 patients</td><td valign="top" align="left" rowspan="1" colspan="1"><bold>1° endpoint:</bold> 12-month MACE was 4.5%<break></break><bold>2° endpoints:</bold> 2-year MACE was 6.8% (cardiac death 1.5%, MI 2.4%, TVR 4.3%). ST occurred in 0.8% of patients</td></tr></tbody></table><table-wrap-foot><p>Abbreviations: BMS = bare metal stents; LLL = late lumen loss; TLR = target lesion revascularization; NS = non-significant; RVD = reference vessel diameter; CAD = coronary artery disease; ACS = acute coronary syndrome; SES = sirolimus-eluting stent; ST = stent thrombosis; %DS = percent diameter stenosis; MACE = major adverse coronary event; TV-MI = target-vessel myocardial infarction; TVR = target-vessel restenosis.</p></table-wrap-foot></table-wrap><table-wrap id="T4" position="float"><label>Table 4</label><caption><p>Summary of clinical trials for the Nobori and Ultimaster biolimus-eluting bioabsorbable polymer stent.</p></caption><table frame="border" rules="all" width="100%"><thead><tr><th valign="top" align="center" scope="col" rowspan="1" colspan="1"> <bold>Trial</bold></th><th valign="top" align="center" scope="col" rowspan="1" colspan="1"> <bold>Control</bold></th><th valign="top" align="center" scope="col" rowspan="1" colspan="1"> <bold># of patients/study design</bold></th><th valign="top" align="center" scope="col" rowspan="1" colspan="1"> <bold>Key Results</bold></th></tr></thead><tbody><tr><td valign="top" align="left" scope="row" rowspan="1" colspan="1"> NOBORI CORE 9-month results (2008) [<xref rid="r53" ref-type="bibr">53</xref>]</td><td valign="top" align="left" rowspan="1" colspan="1"> SES</td><td valign="top" align="left" rowspan="1" colspan="1"> 107 patients with <italic>de novo</italic> CAD, randomized 1:1, 5 centers</td><td valign="top" align="left" rowspan="1" colspan="1"> <bold>1° endpoint:</bold> 9-month in-stent LLL Nobori 0.10mm±0.26mm vs SES 0.13mm±0.44mm; <italic>P</italic>=0.660)<break></break> <bold>2° endpoints:</bold><break></break> 12-month MACE Nobori 1.9% vs SES 4.1%<break></break> 9-month in-stent % diameter stenosis for Nobori 13%±10% vs SES 20%±12%; <italic>P</italic>=0.002</td></tr><tr><td valign="top" align="left" scope="row" rowspan="1" colspan="1"> NOBORI 1 Trial – Phase 1<break></break> 9-month results (2007) [<xref rid="r54" ref-type="bibr">54</xref>]</td><td valign="top" align="left" rowspan="1" colspan="1"> PES (TAXUS Express)</td><td valign="top" align="left" rowspan="1" colspan="1"> 120 patients with native CAD, prospective, controlled, noninferiority, randomized 2:1, 29 centers</td><td valign="top" align="left" rowspan="1" colspan="1"> <bold>1° endpoint:</bold> 9-month in-stent LLL with 0.15mm<underline>±</underline>0.27mm vs PES 0.32mm<underline>±</underline>0.33mm; <italic>P</italic>=0.006<break></break> 0% ST for both groups</td></tr><tr><td valign="top" align="left" scope="row" rowspan="1" colspan="1"> NOBORI 1 Trial - Phase 2<break></break> 9-month results (2009) [<xref rid="r118" ref-type="bibr">118</xref>]</td><td valign="top" align="left" rowspan="1" colspan="1"> PES (TAXUS Liberté)</td><td valign="top" align="left" rowspan="1" colspan="1"> 243 patients with native CAD, prospective, controlled, noninferiority, randomized 2:1, 29 centers</td><td valign="top" align="left" rowspan="1" colspan="1"> <bold>1° endpoint:</bold> 9-month in-stent LLL Nobori 0.11mm<underline>±</underline>0.30mm vs PES 0.32mm<underline>±</underline>0.50mm; <italic>P</italic><sub>noninferiority</sub><0.001, <italic>P</italic><sub>superiority</sub>=0.001<break></break> <bold>2° endpoints:</bold><break></break> 9-month MACE Nobori 4.6% vs PES 5.6%<break></break> ST rate Nobori 0% vs PES 4.4%</td></tr><tr><td valign="top" align="left" scope="row" rowspan="1" colspan="1"> NOBORI 1 Trial – Phases 1 & 2 5-year results (2015) [<xref rid="r55" ref-type="bibr">55</xref>]</td><td valign="top" align="left" rowspan="1" colspan="1"> PES</td><td valign="top" align="left" rowspan="1" colspan="1"> 363 patients with native CAD, prospective, controlled, noninferiority, randomized 2:1, 29 centers</td><td valign="top" align="left" rowspan="1" colspan="1"> <bold>1° endpoint:</bold> 5-year TLF Nobori 9.2% vs PES 10.4%<break></break> <bold>2° endpoints:</bold><break></break> TLR Nobori 6.3% vs PES 16.0%)<break></break> Def/prob ST Nobori 0.0% vs PES 3.2%; <italic>P</italic>=0.014</td></tr><tr><td valign="top" align="left" scope="row" rowspan="1" colspan="1"> NOBORI Japan<break></break> 9-month results (2012) [<xref rid="r56" ref-type="bibr">56</xref>]</td><td valign="top" align="left" rowspan="1" colspan="1"> SES</td><td valign="top" align="left" rowspan="1" colspan="1"> 335 patients with <italic>de novo</italic> lesions in up to2 native coronary arteries, controlled, randomized 3:2, 15 centers in Japan</td><td valign="top" align="left" rowspan="1" colspan="1"> <bold>1° endpoint:</bold> Freedom from TVF Nobori 92.6% vs SES 93.8%; <italic>P</italic><sub>noninferiority</sub><0.001<break></break> <bold>2° endpoints:</bold><break></break> 9-month in-stent LLL Nobori 0.12mm±0.30mm vs SES 0.14mm±0.34mm<break></break> 9-month TLR Nobori 0.5% vs 3.9%; <italic>P</italic>=0.04<break></break> 0% def/prob ST for both groups</td></tr><tr><td valign="top" align="left" scope="row" rowspan="1" colspan="1"> SORT OUT V<break></break> 9-month results (2013) [<xref rid="r60" ref-type="bibr">60</xref>]<break></break> NCT01254981</td><td valign="top" align="left" rowspan="1" colspan="1"> SES</td><td valign="top" align="left" rowspan="1" colspan="1"> 1,229, all-comers, noninferiority, randomized 1:1, 3 sites</td><td valign="top" align="left" rowspan="1" colspan="1"> <bold>1° endpoint:</bold> 9-month MACE Nobori 4.1% vs SES 3.1%; <italic>P</italic><sub>noninferiority</sub>=0.06<break></break> <bold>2° endpoint:</bold> 9-month definite ST Nobori 0.7% vs SES 0.2%; <italic>P</italic>=0.03</td></tr><tr><td valign="top" align="left" scope="row" rowspan="1" colspan="1"> COMPARE II 1-year results (2013) [<xref rid="r119" ref-type="bibr">119</xref>]; 3-year results (2015) [<xref rid="r58" ref-type="bibr">58</xref>]<break></break> NCT01233453</td><td valign="top" align="left" rowspan="1" colspan="1"> EES</td><td valign="top" align="left" rowspan="1" colspan="1"> 2,707 patients with RVD between 2.0mm and 4.0mm, prospective, controlled, noninferiority, randomized 2:1, 12 sites</td><td valign="top" align="left" rowspan="1" colspan="1"> <bold>1° endpoint:</bold> 1-year MACE Nobori 5.2% vs EES 4.8%; <italic>P</italic><sub>noninferiority</sub> <0.0001<break></break> <bold>2° endpoints:</bold><break></break> 1-year def/prob ST Nobori 0.8% vs EES 1.0%; <italic>P</italic>=0.58<break></break> 3-year MACE Nobori 11.9% vs EES 11.1%; <italic>P</italic>=0.57<break></break> 3-year ST Nobori 1.2% vs EES 0.8%; <italic>P</italic>=0.33</td></tr><tr><td valign="top" align="left" scope="row" rowspan="1" colspan="1"> NEXT trial 1-year results (2013) [<xref rid="r57" ref-type="bibr">57</xref>]<break></break> NCT01303640</td><td valign="top" align="left" rowspan="1" colspan="1"> EES</td><td valign="top" align="left" rowspan="1" colspan="1"> 3,235 patients with native and graft vessel disease scheduled for PCI, prospective, noninferiority, randomized 1:1, multicenter</td><td valign="top" align="left" rowspan="1" colspan="1"> <bold>1° endpoint:</bold> 1-year TLR Nobori 4.2% vs EES 4.2%; <italic>P</italic><sub>noninferiority</sub> <0.0001, <italic>P</italic><sub>superiority</sub>= 0.93<break></break> <bold>2° endpoints:</bold><break></break> 1-year def ST Nobori 0.25% vs EES 0.06%; <italic>P</italic>=0.18<break></break> 9-month in-segment LLL Nobori 0.03mm±0.39mm vs EES 0.06mm±0.45mm; <italic>P</italic><sub>noninferiority</sub> <0.0001, <italic>P</italic><sub>superiority</sub>=0.52 (266±43 days after stent implantation)</td></tr><tr><td valign="top" align="center" scope="row" rowspan="1" colspan="1"> <bold>Trial</bold></td><td valign="top" align="center" rowspan="1" colspan="1"> <bold>Control</bold></td><td valign="top" align="center" rowspan="1" colspan="1"> <bold># of patients/study design</bold></td><td valign="top" align="center" rowspan="1" colspan="1"> <bold>Key Results</bold></td></tr><tr><td valign="top" align="left" scope="row" rowspan="1" colspan="1"> BASKET-PROVE II<break></break> 2-year results (2015) [<xref rid="r59" ref-type="bibr">59</xref>]<break></break> NCT01166685</td><td valign="top" align="left" rowspan="1" colspan="1"> EES and BMS</td><td valign="top" align="left" rowspan="1" colspan="1"> 2,291 patients with acute or stable CAD, lesions ≥3.0mm in diameter, randomized 1:1:1</td><td valign="top" align="left" rowspan="1" colspan="1"> <bold>1° endpoint:</bold> 2-year MACE Nobori 7.6% vs EES 6.8% vs BMS 12.7%; Nobori vs EES: <italic>P</italic><sub>noninferiority</sub>=0.04, Nobori vs BMS: <italic>P</italic>=0.001<break></break> <bold>2° endpoints:</bold><break></break> 2-year safety end point (combination of VLST, MI, cardiac death) was similar in all three groups</td></tr><tr><td valign="top" align="left" scope="row" rowspan="1" colspan="1"> LONG-DES V trial<break></break> 9-month results (2014) [<xref rid="r61" ref-type="bibr">61</xref>]<break></break> NCT01186120</td><td valign="top" align="left" rowspan="1" colspan="1"> EES</td><td valign="top" align="left" rowspan="1" colspan="1"> 500 patients, long (≥25mm) coronary lesions, prospective, randomized 1:1, multicenter</td><td valign="top" align="left" rowspan="1" colspan="1"> <bold>1° endpoint:</bold> 9-month in-segment LLL Nobori 0.14mm±0.38mm vs EES 0.11mm±0.37mm; <italic>P</italic><sub>non-inferiroity</sub>=0.03, <italic>P</italic><sub>superiority</sub>=0.45<break></break> <bold>2° endpoint:</bold> MACE Nobori 16.7% vs EES 16.5%; <italic>P</italic>=0.94</td></tr><tr><td valign="top" align="left" scope="row" rowspan="1" colspan="1"> INSPIRE 1<break></break> 1-year results [<xref rid="r64" ref-type="bibr">64</xref>]</td><td valign="top" align="left" rowspan="1" colspan="1"> N/A</td><td valign="top" align="left" rowspan="1" colspan="1"> 1066 patients, all-comers registry, multicenter</td><td valign="top" align="left" rowspan="1" colspan="1"> <bold>1° endpoint:</bold> Cardiac death, MI, and clinically driven TVR 4.0% patients; the rate was higher in the complex lesions (5.2% vs 2.5%, <italic>P</italic>=0.03)</td></tr><tr><td valign="top" align="left" scope="row" rowspan="1" colspan="1"> Nobori 2<break></break> 2-year results [<xref rid="r63" ref-type="bibr">63</xref>]<break></break> ISRCTN81649913</td><td valign="top" align="left" rowspan="1" colspan="1"> N/A</td><td valign="top" align="left" rowspan="1" colspan="1"> 3067 patients, all-comers registry, multicenter</td><td valign="top" align="left" rowspan="1" colspan="1"> <bold>1° endpoint:</bold> 2-year TLF 3.9% at 1 year, 5.1% at 2 years<break></break> <bold>2° endpoint:</bold> ARC def/prob ST: 0.68% at 1 year, 0.82% at 2 years</td></tr><tr><td valign="top" align="left" scope="row" rowspan="1" colspan="1"> CENTURY I<break></break> 6 months [<xref rid="r65" ref-type="bibr">65</xref>]<break></break> 4 year [<xref rid="r66" ref-type="bibr">66</xref>]</td><td valign="top" align="left" rowspan="1" colspan="1"> N/A</td><td valign="top" align="left" rowspan="1" colspan="1"> 105 patients, Single-arm, prospective, multicenter</td><td valign="top" align="left" rowspan="1" colspan="1"> <bold>1° endpoint:</bold> late loss at 6 months was 0.04±0.35 mm<break></break> <bold>2° endpoints:</bold> At 4 years: TLF was 6.7% and ARC definite/probable ST was 0.9%</td></tr><tr><td valign="top" align="left" scope="row" rowspan="1" colspan="1"> CENTURY II<break></break> 9 months [<xref rid="r67" ref-type="bibr">67</xref>]; 2 years [<xref rid="r120" ref-type="bibr">120</xref>]</td><td valign="top" align="left" rowspan="1" colspan="1"> EES</td><td valign="top" align="left" rowspan="1" colspan="1"> 1101 patients, prospective, randomized 1:1, multicenter</td><td valign="top" align="left" rowspan="1" colspan="1"> <bold>1° endpoint:</bold> 9-month freedom from TLF Ultimaster 95.6% vs XIENCE 95.1% (P<sub>noninferiority</sub><0.0001).<break></break> <bold>2° endpoint:</bold> 2-year TLF Ultimaster 6.5% vs XIENCE 6.6%<break></break> ARC definite/probable ST 1.1% in each arm</td></tr></tbody></table><table-wrap-foot><p>Abbreviations: BMS = bare metal stents; CAD = coronary artery disease; EES = everolimus-eluting stents; LLL = late lumen loss; MACE = major adverse coronary event; MI = myocardial infarction; PES = paclitaxel-eluting stent; RVD = reference vessel diameter; SES = sirolimus-eluting stent; ST = stent thrombosis; TLF = target lesion failure; TLR = target lesion revascularization; TVR = target-vessel revascularization; VLST = very late stent thrombosis.</p></table-wrap-foot></table-wrap><table-wrap id="T5" position="float"><label>Table 5</label><caption><p>Summary of clinical trials for the Orsiro sirolimus-eluting bioabsorbable polymer stent.</p></caption><table frame="border" rules="all" width="100%"><thead><tr><th valign="top" align="center" scope="col" rowspan="1" colspan="1"><bold>Trial</bold></th><th valign="top" align="center" scope="col" rowspan="1" colspan="1"><bold>Control</bold></th><th valign="top" align="center" scope="col" rowspan="1" colspan="1"><bold># of patients/study design</bold></th><th valign="top" align="center" scope="col" rowspan="1" colspan="1"><bold>Results</bold></th></tr></thead><tbody><tr><td valign="top" align="left" scope="row" rowspan="1" colspan="1">BIOFLOW-I Registry<break></break>[<xref rid="r69" ref-type="bibr">69</xref>]<break></break>NCT01214148</td><td valign="top" align="left" rowspan="1" colspan="1">None</td><td valign="top" align="left" rowspan="1" colspan="1">First-in-human, single-arm registry of 30 patients with a single <italic>de novo</italic> lesion ≥22 mm, RVD 2.5 - 3.5 mm, and<break></break>>50% to <90% diameter stenosis were enrolled at two sites</td><td valign="top" align="left" rowspan="1" colspan="1"><bold>1° endpoint:</bold> In-stent late loss at 9 mos was 0.05±0.22 mm<break></break>1y clinical outcomes:<break></break>MACE was 10%, no MI or ST</td></tr><tr><td valign="top" align="left" scope="row" rowspan="1" colspan="1">BIOFLOW II<break></break>[<xref rid="r70" ref-type="bibr">70</xref>]<break></break>NCT01356888</td><td valign="top" align="left" rowspan="1" colspan="1">EES</td><td valign="top" align="left" rowspan="1" colspan="1">N=452 prospective, multicenter, randomized (2:1), excluded AMI, LM, 3VD, LVEF<30%</td><td valign="top" align="left" rowspan="1" colspan="1"><bold>1° endpoint:</bold> In stent late loss at 9 mos: Orsiro 0.10 ± 0.32 vs EES 0.11 ± 0.29 mm <italic>P</italic><sub>noninferiority</sub><0.0001<break></break>TLF: Orsiro 6.5% vs 8.0% <italic>P</italic>=0.58<break></break>ST: 0 in each arm</td></tr><tr><td valign="top" align="left" scope="row" rowspan="1" colspan="1">BIOSCIENCE<break></break>[<xref rid="r71" ref-type="bibr">71</xref>]<break></break>NCT01443104</td><td valign="top" align="left" rowspan="1" colspan="1">EES</td><td valign="top" align="left" rowspan="1" colspan="1">N=2,119; Prospective, multisite, randomized (1:1), single-blind, noninferiority; 9 European sites, unselected patient population</td><td valign="top" align="left" rowspan="1" colspan="1">Primary Endpoint: 12-mo TLF occurred in 6.5% vs 6.6% of subjects in the Orsiro and XIENCE groups (<italic>P<sub>noninferiority</sub></italic><0.0004)<break></break>No significant differences were noted in rates of definite ST (0.9% vs 0.4%, <italic>P</italic>=0.16).<break></break>STEMI patients<break></break>12-mo TLF 3.3% vs 8.7%, <italic>P</italic>=0.024</td></tr><tr><td valign="top" align="left" scope="row" rowspan="1" colspan="1">BIOFLOW III Registry<break></break>[<xref rid="r72" ref-type="bibr">72</xref>]<break></break>NCT01553526</td><td valign="top" align="left" rowspan="1" colspan="1">None</td><td valign="top" align="left" rowspan="1" colspan="1">N=1356 prospective, multicenter, all-comers</td><td valign="top" align="left" rowspan="1" colspan="1"><bold>1° endpoint:</bold> TLF at 12 months: 5.1%</td></tr></tbody></table><table-wrap-foot><p>Abbreviations: 3VD = 3 vessel disease; AMI = acute myocardial infarction; EES = everolimus-eluting stents; LM = left main; LVEF = left ventricular ejection fraction; MI = myocardial infarction; PES = paclitaxel-eluting stent; RVD = reference vessel diameter; SES = sirolimus-eluting stent; ST = stent thrombosis; STEMI = ST-elevation myocardial infarction; TLF = target lesion failure; TLR = target lesion revascularization; TVR = target-vessel revascularization.</p></table-wrap-foot></table-wrap></floats-group></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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