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Patients were allocated 1:1 to either Luminor\u00ae 35 DCB angioplasty or plain old balloon angioplasty (POBA). Assessment at 5\u00a0years included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), clinical improvement, and target limb amputation. Long-term vital status was ascertained in 97.1% of the participants.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      <jats:italic>Kaplan<\/jats:italic>\n                      \u2013Meier curves at 5\u00a0years demonstrate a primary patency of 61.4% after DCB angioplasty and 53.5% after POBA (log-rank\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.040) with a decreasing difference throughout the observation period. Freedom from TLR was 82.1% and 73.7%, respectively (log-rank\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.050). Incidence of primary clinical improvement was similar between groups (61% DCB vs. 64% POBA,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.94). Major target limb amputation was necessary in one POBA-group participant. Freedom from all-cause death at 5\u00a0years was 88.5% after DCB and 86.0% after POBA (log-rank\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.34).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Primary patency after femoropopliteal DCB angioplasty remained superior to POBA throughout 5\u00a0years, however, with decreasing difference. Clinical improvement, freedom from TLR, and all-cause mortality were similar between groups over the long term. (Effectiveness of Paclitaxel-Coated Luminor\u00ae Balloon Catheter Versus Uncoated Balloon Catheter in the Superficial Femoral Artery [EffPac]; NCT02540018).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00270-022-03265-1","type":"journal-article","created":{"date-parts":[[2022,9,11]],"date-time":"2022-09-11T10:02:11Z","timestamp":1662890531000},"page":"1774-1783","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":28,"title":["Long-Term Effectiveness and Safety of Femoropopliteal Drug-Coated Balloon Angioplasty : 5-Year Results of the Randomized Controlled EffPac Trial"],"prefix":"10.1007","volume":"45","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4048-3938","authenticated-orcid":false,"given":"Ulf","family":"Teichgr\u00e4ber","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Lehmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maja","family":"Ingwersen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ren\u00e9","family":"Aschenbach","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Zeller","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Klaus","family":"Brechtel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erwin","family":"Blessing","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Lichtenberg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"von Flotow","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Britta","family":"Heilmeier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sebastian","family":"Sixt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steffen","family":"Brucks","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Erbel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ulrich","family":"Beschorner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Werk","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vicen\u00e7","family":"Riambau","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Wienke","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christof","family":"Klumb","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Markus","family":"Thieme","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dierk","family":"Scheinert","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,9,11]]},"reference":[{"issue":"1","key":"3265_CR1","doi-asserted-by":"publisher","first-page":"528","DOI":"10.1186\/s13063-016-1657-x","volume":"17","author":"U Teichgr\u00e4ber","year":"2016","unstructured":"Teichgr\u00e4ber U, Aschenbach R, Scheinert D, et al. 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TZ is co-principal investigator of the ILICO study, a study sponsored by iVascular. All other authors declare that they have no conflict of interest with respect to this article.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The study protocol was approved by the Friedrich-Schiller-University ethics committee. In addition, the study protocol had been approved by the local ethics committees of all participating sites. The study was conducted according to the Declaration of Helsinki.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}},{"value":"Written, informed consent to participate in the study was obtained from all patients.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed Consent"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for Publication"}}]}}