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The aim of the current study was to investigate inhibition of neointimal formation and potential adverse effects after treatment with a novel double-dose DCB in swine.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Material and methods<\/jats:title>\n                <jats:p>A four-week study was performed in peripheral arteries of 12 domestic pigs after vessel injury and stent implantation. The novel double-dose DCB with 6-\u00b5g paclitaxel (Ptx)\/mm<jats:sup>2<\/jats:sup> balloon surface (1\u2009\u00d7\u20096) was compared to a standard DCB with 3.5\u00a0\u00b5g Ptx\/mm<jats:sup>2<\/jats:sup> (3.5) and uncoated balloons (POBA). Potential adverse effects were stimulated by using three fully overlapping DCBs with 6\u00a0\u00b5g Ptx\/mm<jats:sup>2<\/jats:sup> each (3\u2009\u00d7\u20096). Quantitative angiography, histomorphometry and histopathological analyses were performed.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Higher paclitaxel doses per square millimeter of treated arteries were associated with reduced late lumen loss (LLL) in quantitative angiography 4\u00a0weeks after treatment (POBA: 0.91\u2009\u00b1\u20090.75\u00a0mm; 3.5: 0.45\u2009\u00b1\u20090.53\u00a0mm; 1\u2009\u00d7\u20096: 0.21\u2009\u00b1\u20090.41\u00a0mm; 3\u2009\u00d7\u20096:\u2009\u2212\u20090.38\u2009\u00b1\u20090.65\u00a0mm). In histomorphometry, maximal neointimal thickness and neointimal area were the lowest for the 1\u2009\u00d7\u20096 group (0.15\u2009\u00b1\u20090.06\u00a0mm\/1.5\u2009\u00b1\u20090.4\u00a0mm<jats:sup>2<\/jats:sup>), followed by 3\u2009\u00d7\u20096 (0.20\u2009\u00b1\u20090.07\u00a0mm\/1.8\u2009\u00b1\u20090.4\u00a0mm<jats:sup>2<\/jats:sup>), 3.5\u00a0(0.22\u2009\u00b1\u20090.12\u00a0mm\/2.2\u2009\u00b1\u20091.1\u00a0mm<jats:sup>2<\/jats:sup>) and POBA (0.30\u2009\u00b1\u20090.07\u00a0mm\/3.2\u2009\u00b1\u20090.7\u00a0mm<jats:sup>2<\/jats:sup>). Downstream tissue showed histopathological changes in all groups including POBA, in larger number and different quality (e.g., edema, inflammation, vessel wall necrosis, vasculitis and perivasculitis) in the 3\u2009\u00d7\u20096 group, which did not cause clinical or functional abnormalities throughout the study.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>Treatment with the double-dose DCB (6\u00a0\u00b5g Ptx\/mm<jats:sup>2<\/jats:sup>) tended to increase inhibition of in-stent neointimal formation and to diminish LLL after peripheral intervention in the porcine model compared to a market-approved DCB with 3.5\u00a0\u00b5g Ptx\/mm<jats:sup>2<\/jats:sup>.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s00270-022-03277-x","type":"journal-article","created":{"date-parts":[[2022,9,15]],"date-time":"2022-09-15T20:02:51Z","timestamp":1663272171000},"page":"1822-1831","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Improvement of Outcome for Treatment of \u2018Restenosis-prone\u2019 Vascular Lesions? Potential Impact of the Paclitaxel dose on Late Lumen Loss in Porcine Peripheral Arteries"],"prefix":"10.1007","volume":"45","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6090-865X","authenticated-orcid":false,"given":"Ole","family":"Gemeinhardt","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tobias","family":"Haase","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beatrix","family":"Schnorr","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Xie","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melanie","family":"L\u00f6chel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Denise","family":"Sch\u00fctt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antje","family":"Mittag","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wolfram","family":"Haider","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephanie","family":"Bettink","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ulrich","family":"Speck","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gunnar","family":"Tepe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,9,15]]},"reference":[{"issue":"7","key":"3277_CR1","doi-asserted-by":"publisher","first-page":"949","DOI":"10.1007\/s00270-019-02194-w","volume":"42","author":"T Albrecht","year":"2019","unstructured":"Albrecht T, Schnorr B, Kutschera M, Waliszewski MW. 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