{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,15]],"date-time":"2026-04-15T22:23:01Z","timestamp":1776291781122,"version":"3.50.1"},"reference-count":17,"publisher":"Public Library of Science (PLoS)","issue":"7","license":[{"start":{"date-parts":[[2022,7,7]],"date-time":"2022-07-07T00:00:00Z","timestamp":1657152000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Purpose<\/jats:title>\n<jats:p>Drug-eluting stents (DESs) play an important role in endovascular therapy (EVT) for femoropopliteal (FP) lesions. Cilostazol improves patency after bare-metal nitinol stent (BNS) implantation for femoropopliteal lesions. This study aimed to establish whether cilostazol is effective in improving the patency of DESs and determine whether BNS or DESs with or without cilostazol are more effective in improving the 12-month patency after EVT for FP lesions.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Materials and methods<\/jats:title>\n<jats:p>In this prospective, open-label, multicenter study, 85 patients with symptomatic peripheral artery disease due to de novo FP lesions were enrolled and treated with DESs with cilostazol from eight cardiovascular centers between April 2018 and May 2019. They were compared with 255 patients from the DEBATE SFA study, in which patients were randomly assigned to the BNS, BNS with cilostazol, or DES groups. The primary endpoint was the 12-month patency rate using duplex ultrasound (peak systolic velocity ratio &lt; 2.5). This study was approved by the ethics committee of each hospital.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Results<\/jats:title>\n<jats:p>The 12-month patency rates for the BNS, BNS with cilostazol, DES, and DES with cilostazol groups were 77.6%, 93.1%, 82.8%, and 94.2%, respectively (p = 0.007). The 12-month patency rate was higher in the DES with cilostazol group than in the DES group (p = 0.044). In small vessels, the DES with cilostazol group had a higher patency rate than the DES group (100.0% vs. 83.4%, p = 0.023).<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Conclusions<\/jats:title>\n<jats:p>DES with cilostazol showed better patency than DES alone. Cilostazol improved patency after EVT with DES in FP lesions and small vessels.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec005\">\n<jats:title>Clinical trial registration<\/jats:title>\n<jats:p>University Hospital Medical Information Network Clinical Trials Registry (no. <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/center6.umin.ac.jp\/cgi-open-bin\/ctr_e\/ctr_view.cgi?recptno=000032473\" xlink:type=\"simple\">UMIN 000032473<\/jats:ext-link>).<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0270992","type":"journal-article","created":{"date-parts":[[2022,7,7]],"date-time":"2022-07-07T17:39:30Z","timestamp":1657215570000},"page":"e0270992","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":6,"title":["Cilostazol effectiveness in reducing drug-coated stent restenosis in the superficial femoral artery: The ZERO study"],"prefix":"10.1371","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5443-0530","authenticated-orcid":true,"given":"Takashi","family":"Miura","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yusuke","family":"Miyashita","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Koji","family":"Hozawa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tatsuki","family":"Doijiri","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tamon","family":"Kato","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naoki","family":"Hayakawa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naoto","family":"Hashizume","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masatsugu","family":"Nakano","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Uichi","family":"Ikeda","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Koichiro","family":"Kuwahara","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"on 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Werk","year":"2008","journal-title":"Circulation"},{"issue":"3","key":"pone.0270992.ref003","doi-asserted-by":"crossref","first-page":"282","DOI":"10.1016\/j.jcin.2013.01.128","article-title":"2-Year restenosis of paclitaxel-eluting balloons for femoropopliteal artery disease: evidence from a multicenter registry","volume":"6","author":"A Micari","year":"2013","journal-title":"JACC Cardiovasc Intv"},{"issue":"15","key":"pone.0270992.ref004","doi-asserted-by":"crossref","first-page":"1472","DOI":"10.1161\/CIRCULATIONAHA.115.016900","article-title":"Durable clinical effectiveness with paclitaxel-eluting stents in the femoropopliteal artery: 5-year results of the Zilver PTX randomized trial","volume":"133","author":"MD Dake","year":"2016","journal-title":"Circulation"},{"issue":"10157","key":"pone.0270992.ref005","doi-asserted-by":"crossref","first-page":"1541","DOI":"10.1016\/S0140-6736(18)32262-1","article-title":"A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a 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femoropopliteal lesions: the Viabahn-25 cm trial","volume":"21","author":"T Zeller","year":"2014","journal-title":"J Endovasc Ther"},{"issue":"1","key":"pone.0270992.ref016","doi-asserted-by":"crossref","first-page":"16","DOI":"10.1016\/j.jacc.2011.09.036","article-title":"Classification and clinical impact of restenosis after femoropopliteal stenting","volume":"59","author":"A Tosaka","year":"2012","journal-title":"J Am Coll Cardiol"},{"issue":"8","key":"pone.0270992.ref017","doi-asserted-by":"crossref","first-page":"828","DOI":"10.1016\/j.jcin.2016.01.007","article-title":"The characteristics of in-stent restenosis after drug-eluting stent implantation in femoropopliteal lesions and 1-year prognosis after repeat endovascular therapy for these lesions","volume":"9","author":"O Iida","year":"2016","journal-title":"JACC Cardiovasc Intv"}],"container-title":["PLOS 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