{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T03:01:54Z","timestamp":1787022114641,"version":"build-2736575974"},"reference-count":88,"publisher":"Public Library of Science (PLoS)","issue":"10","license":[{"start":{"date-parts":[[2022,10,13]],"date-time":"2022-10-13T00:00:00Z","timestamp":1665619200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"the research grants council of hong kong","award":["17308420"],"award-info":[{"award-number":["17308420"]}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Clinical benefit of paclitaxel-coated devices for patients with peripheral arterial disease has been confirmed in randomized controlled trials (RCTs). A meta-analysis published in 2018 identified late mortality risk over a long follow-up period due to use of paclitaxel-coated devices in the femoropopliteal arteries, which caused enormous controversy and debates globally. This study aims to further evaluate the safety of paclitaxel-coated devices by incorporating the most recently published data.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec002\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We searched for candidate studies in PubMed (MEDLINE), Scopus, EMBASE (Ovid) online databases, government web archives and international cardiovascular conferences. Safety endpoints of interest included all-cause mortality rates at one, two and five years and the risk ratio (RR) was used as the summary measure. The primary analysis was performed using random-effects models to account for potential clinical heterogeneity.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec003\">\n                    <jats:title>Findings<\/jats:title>\n                    <jats:p>Thirty-nine RCTs including 9164 patients were identified. At one year, the random-effects model yielded a pooled RR of 1.06 (95% CI [0.87, 1.29]) indicating no difference in short-term all-cause deaths between the paclitaxel and control groups (crude mortality, 4.3%, 214\/5025 versus 4.5%, 177\/3965). Two-year mortality was reported in 26 RCTs with 382 deaths out of 3788 patients (10.1%) in the paclitaxel arm and 299 out of 2955 patients (10.1%) in the control arm and no association was found between increased risk of death and usage of paclitaxel-coated devices (RR 1.08, 95% CI [0.93, 1.25]). Eight RCTs recorded all-cause deaths up to five years and a pooled RR of 1.18 (95% CI [0.92, 1.51]) demonstrated no late mortality risk due to use of paclitaxel-coated devices (crude mortality, paclitaxel 18.2%, 247\/1360 versus control 15.2%, 122\/805).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec004\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>We found no significant difference in either short- or long-term all-cause mortalities between patients receiving paclitaxel-coated and uncoated devices. Further research on the longer-term safety of paclitaxel usage (e.g., 8- or 10-year) is warranted.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec005\">\n                    <jats:title>Registration<\/jats:title>\n                    <jats:p>PROSPERO, CRD42021246291.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1371\/journal.pone.0275888","type":"journal-article","created":{"date-parts":[[2022,10,13]],"date-time":"2022-10-13T13:31:01Z","timestamp":1665667861000},"page":"e0275888","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":7,"title":["Safety of paclitaxel-coated devices in the femoropopliteal arteries: A systematic review and meta-analysis"],"prefix":"10.1371","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1628-8638","authenticated-orcid":true,"given":"Chenyang","family":"Zhang","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guosheng","family":"Yin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2022,10,13]]},"reference":[{"key":"pone.0275888.ref001","doi-asserted-by":"crossref","first-page":"e5208","DOI":"10.1136\/bmj.e5208","article-title":"Diagnosis and management of peripheral arterial disease","volume":"345","author":"G Peach","year":"2012","journal-title":"BMJ"},{"key":"pone.0275888.ref002","doi-asserted-by":"crossref","first-page":"e4947","DOI":"10.1136\/bmj.e4947","article-title":"Diagnosis and management of lower limb peripheral arterial disease: summary of NICE guidance","volume":"345","author":"Guideline Development G","year":"2012","journal-title":"BMJ"},{"issue":"1","key":"pone.0275888.ref003","doi-asserted-by":"crossref","first-page":"44","DOI":"10.1093\/eurheartj\/ehn514","article-title":"Routine stent implantation vs. percutaneous transluminal angioplasty in femoropopliteal artery disease: a meta-analysis of randomized controlled trials","volume":"30","author":"C Kasapis","year":"2009","journal-title":"Eur Heart J"},{"issue":"4","key":"pone.0275888.ref004","doi-asserted-by":"crossref","first-page":"582","DOI":"10.1161\/CIRCINTERVENTIONS.112.969972","article-title":"Paclitaxel-coated versus uncoated balloon angioplasty reduces target lesion revascularization in patients with femoropopliteal arterial disease: a meta-analysis of randomized trials","volume":"5","author":"S Cassese","year":"2012","journal-title":"Circ Cardiovasc Interv"},{"key":"pone.0275888.ref005","doi-asserted-by":"crossref","first-page":"42","DOI":"10.1016\/j.eclinm.2019.09.004","article-title":"Benefit and risk from paclitaxel-coated balloon angioplasty for the treatment of femoropopliteal artery disease: A systematic review and meta-analysis of randomised controlled trials","volume":"16","author":"C Klumb","year":"2019","journal-title":"EClinicalMedicine"},{"issue":"6","key":"pone.0275888.ref006","doi-asserted-by":"crossref","first-page":"e007702","DOI":"10.1161\/CIRCINTERVENTIONS.118.007702","article-title":"Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions","volume":"12","author":"JA Laird","year":"2019","journal-title":"Circ Cardiovasc Interv"},{"issue":"24","key":"pone.0275888.ref007","doi-asserted-by":"crossref","first-page":"e011245","DOI":"10.1161\/JAHA.118.011245","article-title":"Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta-Analysis of Randomized Controlled Trials","volume":"7","author":"K Katsanos","year":"2018","journal-title":"J Am Heart Assoc"},{"key":"pone.0275888.ref008","unstructured":"FDA. Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality\u2014Letter to Health Care Providers. FDA; January 17, 2019."},{"key":"pone.0275888.ref009","unstructured":"FDA. UPDATE: Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality\u2014Letter to Health Care Providers. In: FDA, editor. March 15, 2019."},{"issue":"26","key":"pone.0275888.ref010","doi-asserted-by":"crossref","first-page":"2538","DOI":"10.1056\/NEJMoa2005206","article-title":"Mortality with Paclitaxel-Coated Devices in Peripheral Artery Disease","volume":"383","author":"J Nordanstig","year":"2020","journal-title":"N Engl J Med"},{"issue":"1","key":"pone.0275888.ref011","doi-asserted-by":"crossref","first-page":"224","DOI":"10.1186\/s13063-017-1968-6","article-title":"BAlloon versus Stenting in severe Ischaemia of the Leg-3 (BASIL-3): study protocol for a randomised controlled trial","volume":"18","author":"BD Hunt","year":"2017","journal-title":"Trials"},{"key":"pone.0275888.ref012","unstructured":"Agency MHpR. Recommendations from the independent Expert Advisory Group on the use of Paclitaxel Drug Coated Balloons (DCBs) and Drug Eluting Stents (DESs) to the MHRA. In: Agency MHpR, editor. June 3, 2019."},{"issue":"16","key":"pone.0275888.ref013","doi-asserted-by":"crossref","first-page":"1342","DOI":"10.1161\/CIRCULATIONAHA.119.041099","article-title":"Paclitaxel-Coated Balloons and Eluting Stents: Is There a Mortality Risk in Patients With Peripheral Artery Disease?","volume":"140","author":"JA Beckman","year":"2019","journal-title":"Circulation"},{"key":"pone.0275888.ref014","doi-asserted-by":"crossref","first-page":"n71","DOI":"10.1136\/bmj.n71","article-title":"The PRISMA 2020 statement: an updated guideline for reporting systematic reviews","volume":"372","author":"MJ Page","year":"2021","journal-title":"BMJ"},{"key":"pone.0275888.ref015","doi-asserted-by":"crossref","first-page":"l4898","DOI":"10.1136\/bmj.l4898","article-title":"RoB 2: a revised tool for assessing risk of bias in randomised trials","volume":"366","author":"JAC Sterne","year":"2019","journal-title":"BMJ"},{"key":"pone.0275888.ref016","article-title":"Summing Up: The Science of Reviewing Research","author":"D.B LRJP","year":"1984","journal-title":"Cambridge: Harvard University Press"},{"issue":"7109","key":"pone.0275888.ref017","doi-asserted-by":"crossref","first-page":"629","DOI":"10.1136\/bmj.315.7109.629","article-title":"Bias in meta-analysis detected by a simple, graphical test","volume":"315","author":"M Egger","year":"1997","journal-title":"BMJ"},{"issue":"1","key":"pone.0275888.ref018","doi-asserted-by":"crossref","first-page":"230","DOI":"10.1016\/j.jvs.2009.08.073","article-title":"Critical limb ischemia","volume":"51","author":"VN Varu","year":"2010","journal-title":"Journal of Vascular Surgery"},{"issue":"10","key":"pone.0275888.ref019","first-page":"1123","article-title":"1-Year Results From the RANGER II SFA Randomized Trial of the Ranger Drug-Coated Balloon","volume":"14","author":"R Sachar","year":"2021","journal-title":"JACC: Cardiovascular Interventions"},{"key":"pone.0275888.ref020","unstructured":"Brodmann M, editor 2-Year Results of the RANGER II SFA Randomized Trial. LINC symposium; June 2022."},{"issue":"10","key":"pone.0275888.ref021","doi-asserted-by":"crossref","first-page":"934","DOI":"10.1016\/j.jcin.2018.01.276","article-title":"12-Month Results From the First-in-Human Randomized Study of the Ranger Paclitaxel-Coated Balloon for Femoropopliteal Treatment","volume":"11","author":"S Steiner","year":"2018","journal-title":"JACC Cardiovasc Interv"},{"issue":"18","key":"pone.0275888.ref022","doi-asserted-by":"crossref","first-page":"1941","DOI":"10.1016\/j.jcin.2016.06.055","article-title":"Acotec Drug-Coated Balloon Catheter: Randomized, Multicenter, Controlled Clinical Study in Femoropopliteal Arteries: Evidence From the AcoArt I Trial","volume":"9","author":"X Jia","year":"2016","journal-title":"JACC Cardiovasc Interv"},{"issue":"10","key":"pone.0275888.ref023","doi-asserted-by":"crossref","first-page":"1535","DOI":"10.1007\/s00270-017-1713-2","article-title":"Angiographic and Clinical Outcomes After Treatment of Femoro-Popliteal Lesions with a Novel Paclitaxel-Matrix-Coated Balloon Catheter","volume":"40","author":"G Tepe","year":"2017","journal-title":"Cardiovasc Intervent Radiol"},{"issue":"1 Pt A","key":"pone.0275888.ref024","doi-asserted-by":"crossref","first-page":"102","DOI":"10.1016\/j.jcin.2014.07.023","article-title":"Angioplasty of femoral-popliteal arteries with drug-coated balloons: 5-year follow-up of the THUNDER trial","volume":"8","author":"G Tepe","year":"2015","journal-title":"JACC Cardiovasc Interv"},{"issue":"7","key":"pone.0275888.ref025","doi-asserted-by":"crossref","first-page":"2221","DOI":"10.3390\/jcm9072221","article-title":"Assessment of Mortality and Factors Affecting Outcome of Use of Paclitaxel-Coated Stents and Bare Metal Stents in Femoropopliteal PAD","volume":"9","author":"A Falkowski","year":"2020","journal-title":"Journal of Clinical Medicine"},{"key":"pone.0275888.ref026","unstructured":"FDA. Circulatory System Devices Panel June 19, 2019 FDA Executive Summary. In: FDA, editor. 2019."},{"issue":"2","key":"pone.0275888.ref027","first-page":"207","article-title":"The \"DEBELLUM\"\u2014lower limb multilevel treatment with drug eluting balloon\u2014randomized trial: 1-year results","volume":"55","author":"F Fanelli","year":"2014","journal-title":"J Cardiovasc Surg (Torino)"},{"issue":"6","key":"pone.0275888.ref028","first-page":"679","article-title":"Drug coated balloon supported Supera stent versus Supera stent in intermediate and long-segment lesions of the superficial femoral artery: 2-year results of the RAPID Trial","volume":"60","author":"SW de Boer","year":"2019","journal-title":"J Cardiovasc Surg (Torino)"},{"issue":"23","key":"pone.0275888.ref029","doi-asserted-by":"crossref","first-page":"2347","DOI":"10.1016\/j.jcin.2018.07.041","article-title":"Drug-Coated Balloon Angioplasty Compared With Uncoated Balloons in the Treatment of 200 Chinese Patients With Severe Femoropopliteal Lesions: 24-Month Results of AcoArt I","volume":"11","author":"Y Xu","year":"2018","journal-title":"JACC Cardiovasc Interv"},{"issue":"2","key":"pone.0275888.ref030","doi-asserted-by":"crossref","first-page":"478","DOI":"10.1148\/radiol.2020191619","article-title":"Drug-coated Balloon Angioplasty of Femoropopliteal Lesions Maintained Superior Efficacy over Conventional Balloon: 2-year Results of the Randomized EffPac Trial","volume":"295","author":"U Teichgraber","year":"2020","journal-title":"Radiology"},{"issue":"23","key":"pone.0275888.ref031","doi-asserted-by":"crossref","first-page":"2230","DOI":"10.1161\/CIRCULATIONAHA.115.017364","article-title":"Drug-Coated Balloon Versus Standard Balloon for Superficial Femoral Artery In-Stent Restenosis: The Randomized Femoral Artery In-Stent Restenosis (FAIR) Trial","volume":"132","author":"H Krankenberg","year":"2015","journal-title":"Circulation"},{"issue":"5","key":"pone.0275888.ref032","doi-asserted-by":"crossref","first-page":"495","DOI":"10.1161\/CIRCULATIONAHA.114.011004","article-title":"Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial","volume":"131","author":"G Tepe","year":"2015","journal-title":"Circulation"},{"issue":"4","key":"pone.0275888.ref033","doi-asserted-by":"crossref","first-page":"664","DOI":"10.1002\/ccd.28048","article-title":"Drug-coated balloon versus uncoated percutaneous transluminal angioplasty for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery: 2-year results of the MDT-2113 SFA Japan randomized trial","volume":"93","author":"O Iida","year":"2019","journal-title":"Catheter Cardiovasc Interv"},{"issue":"1","key":"pone.0275888.ref034","doi-asserted-by":"crossref","first-page":"109","DOI":"10.1177\/1526602817745565","article-title":"Drug-Coated Balloon vs Standard Percutaneous Transluminal Angioplasty for the Treatment of Atherosclerotic Lesions in the Superficial Femoral and Proximal Popliteal Arteries: One-Year Results of the MDT-2113 SFA Japan Randomized Trial","volume":"25","author":"O Iida","year":"2018","journal-title":"J Endovasc Ther"},{"key":"pone.0275888.ref035","doi-asserted-by":"crossref","first-page":"36","DOI":"10.1016\/j.avsg.2018.04.042","article-title":"Drug-Coated versus Plain Balloon Angioplasty in Bypass Vein Grafts (the DRECOREST I-Study)","volume":"55","author":"P Bjorkman","year":"2019","journal-title":"Ann Vasc Surg"},{"issue":"12","key":"pone.0275888.ref036","doi-asserted-by":"crossref","first-page":"1295","DOI":"10.1016\/j.jcin.2013.07.010","article-title":"Drug-eluting balloon in peripheral intervention for the superficial femoral artery: the DEBATE-SFA randomized trial (drug eluting balloon in peripheral intervention for the superficial femoral artery)","volume":"6","author":"F Liistro","year":"2013","journal-title":"JACC Cardiovasc Interv"},{"key":"pone.0275888.ref037","doi-asserted-by":"crossref","first-page":"165","DOI":"10.1016\/j.avsg.2018.04.014","article-title":"Drug-Eluting Stent Shows Similar Patency Results as Prosthetic Bypass in Patients with Femoropopliteal Occlusion in a Randomized Trial","volume":"53","author":"P Bj\u00f6rkman","year":"2018","journal-title":"Annals of Vascular Surgery"},{"issue":"8","key":"pone.0275888.ref038","doi-asserted-by":"crossref","first-page":"e006564","DOI":"10.1161\/CIRCINTERVENTIONS.118.006564","article-title":"Drug-Eluting Versus Bare-Metal Stent Implantation With or Without Cilostazol in the Treatment of the Superficial Femoral Artery","volume":"11","author":"T Miura","year":"2018","journal-title":"Circ Cardiovasc Interv"},{"issue":"21","key":"pone.0275888.ref039","doi-asserted-by":"crossref","first-page":"2329","DOI":"10.1016\/j.jacc.2015.09.063","article-title":"Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA","volume":"66","author":"JR Laird","year":"2015","journal-title":"J Am Coll Cardiol"},{"issue":"15","key":"pone.0275888.ref040","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":"18","key":"pone.0275888.ref041","doi-asserted-by":"crossref","first-page":"e1633","DOI":"10.4244\/EIJ-D-19-00292","article-title":"Efficacy and safety of a novel paclitaxel-nano-coated balloon for femoropopliteal angioplasty: one-year results of the EffPac trial","volume":"15","author":"U Teichgraber","year":"2020","journal-title":"EuroIntervention"},{"key":"pone.0275888.ref042","unstructured":"Gou\u00ebffic Y, editor EMINENT: Randomized Trial of Eluvia DES vs Bare Metal Stents 12-month Effectiveness, Safety and Subgroup Analysis. LINC symposium; June 2022."},{"key":"pone.0275888.ref043","unstructured":"Brodmann M, editor Final Long-Term Mortality Results of Paclitaxel-Coated DCBs from the ILLUMENATE RCTs 5-Year Data from EU RCT and Pivotal studies. LINC symposium; January 2021."},{"issue":"13","key":"pone.0275888.ref044","doi-asserted-by":"crossref","first-page":"1358","DOI":"10.1161\/CIRCULATIONAHA.107.735985","article-title":"Inhibition of Restenosis in Femoropopliteal Arteries","volume":"118","author":"M Werk","year":"2008","journal-title":"Circulation"},{"issue":"7","key":"pone.0275888.ref045","article-title":"ISAR-PEBIS (Paclitaxel-Eluting Balloon Versus Conventional Balloon Angioplasty for In-Stent Restenosis of Superficial Femoral Artery): A Randomized Trial","volume":"6","author":"I Ott","year":"2017","journal-title":"J Am Heart Assoc"},{"issue":"1","key":"pone.0275888.ref046","doi-asserted-by":"crossref","first-page":"10","DOI":"10.1016\/j.jcin.2013.05.022","article-title":"The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty","volume":"7","author":"D Scheinert","year":"2014","journal-title":"JACC Cardiovasc Interv"},{"issue":"7","key":"pone.0275888.ref047","doi-asserted-by":"crossref","first-page":"689","DOI":"10.1056\/NEJMoa0706356","article-title":"Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg","volume":"358","author":"G Tepe","year":"2008","journal-title":"N Engl J Med"},{"key":"pone.0275888.ref048","article-title":"Long-term safety and efficacy of angioplasty of femoropopliteal artery disease with drug-coated balloons from the AcoArt I trial","author":"Y Xu","year":"2021","journal-title":"J Vasc Surg"},{"issue":"23","key":"pone.0275888.ref049","doi-asserted-by":"crossref","first-page":"2227","DOI":"10.1161\/CIRCULATIONAHA.116.026493","article-title":"Low-Dose Paclitaxel-Coated Versus Uncoated Percutaneous Transluminal Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease: One-Year Results of the ILLUMENATE European Randomized Clinical Trial (Randomized Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon)","volume":"135","author":"H Schroeder","year":"2017","journal-title":"Circulation"},{"key":"pone.0275888.ref050","unstructured":"Rosenfield K, editor The LUTONIX DCB Program Safety Track Record and Other Considerations. Cardiovascular Research Technologies Conference; May 2019."},{"issue":"4","key":"pone.0275888.ref051","doi-asserted-by":"crossref","first-page":"401","DOI":"10.1177\/1358863X20988360","article-title":"Microcrystalline paclitaxel-coated balloon for revascularization of femoropopliteal artery disease: Three-year outcomes of the randomized BIOPAC trial","volume":"26","author":"P Nowakowski","year":"2021","journal-title":"Vascular Medicine"},{"key":"pone.0275888.ref052","article-title":"A Multicenter Randomized Trial Assessing ZENFlow Carrier-Free Drug-Coated Balloon for the Treatment of Femoropopliteal Artery Lesions","volume":"9","author":"L Ni","year":"2022","journal-title":"Frontiers in Cardiovascular Medicine"},{"key":"pone.0275888.ref053","unstructured":"Teichgr\u00e4ber U, editor New safety and effectiveness data of Luminor DCB at 5 years: the EffPAC trial. LINC symposium; June 2022."},{"issue":"0","key":"pone.0275888.ref054","first-page":"15266028211068769","article-title":"No Mortality Signal With Stellarex Low-Dose Paclitaxel DCB: ILLUMENATE Pivotal 4-Year Outcomes","volume":"0","author":"SP Lyden","journal-title":"Journal of Endovascular Therapy"},{"issue":"3","key":"pone.0275888.ref055","doi-asserted-by":"crossref","first-page":"448","DOI":"10.1177\/17085381211013968","article-title":"Orchid drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of femoropopliteal artery disease: 12-month result of the randomized controlled trial","volume":"30","author":"C-J Liao","year":"2022","journal-title":"Vascular"},{"issue":"2","key":"pone.0275888.ref056","doi-asserted-by":"crossref","first-page":"276","DOI":"10.1177\/1526602820907917","article-title":"Paclitaxel-Coated Balloon vs Uncoated Balloon Angioplasty for Treatment of In-Stent Restenosis in the Superficial Femoral and Popliteal Arteries: The COPA CABANA Trial","volume":"27","author":"G Tepe","year":"2020","journal-title":"J Endovasc Ther"},{"issue":"6","key":"pone.0275888.ref057","doi-asserted-by":"crossref","first-page":"831","DOI":"10.1161\/CIRCINTERVENTIONS.112.971630","article-title":"Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial","volume":"5","author":"M Werk","year":"2012","journal-title":"Circ Cardiovasc Interv"},{"issue":"13","key":"pone.0275888.ref058","doi-asserted-by":"crossref","first-page":"1386","DOI":"10.1016\/j.jcin.2016.04.012","article-title":"Paclitaxel-Eluting Balloon Versus Standard Balloon Angioplasty in In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Artery: 1-Year Results of the PACUBA Trial","volume":"9","author":"CM Kinstner","year":"2016","journal-title":"JACC Cardiovasc Interv"},{"issue":"5","key":"pone.0275888.ref059","doi-asserted-by":"crossref","first-page":"495","DOI":"10.1161\/CIRCINTERVENTIONS.111.962324","article-title":"Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results","volume":"4","author":"MD Dake","year":"2011","journal-title":"Circ Cardiovasc Interv"},{"issue":"1","key":"pone.0275888.ref060","doi-asserted-by":"crossref","first-page":"14","DOI":"10.1177\/1526602814564383","article-title":"Paclitaxel-releasing balloon in femoropopliteal lesions using a BTHC excipient: twelve-month results from the BIOLUX P-I randomized trial","volume":"22","author":"D Scheinert","year":"2015","journal-title":"J Endovasc Ther"},{"issue":"4","key":"pone.0275888.ref061","doi-asserted-by":"crossref","first-page":"447","DOI":"10.1016\/j.jcin.2019.12.028","article-title":"A Polymer-Free Paclitaxel-Eluting Stent Versus a Bare-Metal Stent for De Novo Femoropopliteal Lesions: The BATTLE Trial","volume":"13","author":"Y Goueffic","year":"2020","journal-title":"JACC Cardiovasc Interv"},{"issue":"23","key":"pone.0275888.ref062","doi-asserted-by":"crossref","first-page":"2218","DOI":"10.1161\/CIRCULATIONAHA.116.025329","article-title":"Randomized Comparison of Paclitaxel-Eluting Balloon and Stenting Versus Plain Balloon Plus Stenting Versus Directional Atherectomy for Femoral Artery Disease (ISAR-STATH)","volume":"135","author":"I Ott","year":"2017","journal-title":"Circulation"},{"issue":"5","key":"pone.0275888.ref063","first-page":"365","article-title":"Randomized controlled trial of orchid drug-coated balloon versus standard percutaneous transluminal angioplasty for treatment of femoropopliteal artery in-stent restenosis","volume":"38","author":"CJ Liao","year":"2019","journal-title":"Int Angiol"},{"issue":"11","key":"pone.0275888.ref064","doi-asserted-by":"crossref","first-page":"1513","DOI":"10.1007\/s00270-019-02309-3","article-title":"The Randomized Freeway Stent Study: Drug-Eluting Balloons Outperform Standard Balloon Angioplasty for Postdilatation of Nitinol Stents in the SFA and PI Segment","volume":"42","author":"J Tacke","year":"2019","journal-title":"Cardiovasc Intervent Radiol"},{"key":"pone.0275888.ref065","doi-asserted-by":"crossref","first-page":"164","DOI":"10.1016\/j.ijcard.2020.10.060","article-title":"Reewarm\u2122 PTX drug-coated balloon in the treatment of femoropopliteal artery disease: A multi-center, randomized controlled trial in China","volume":"326","author":"W Ye","year":"2021","journal-title":"International Journal of Cardiology"},{"issue":"24","key":"pone.0275888.ref066","doi-asserted-by":"crossref","first-page":"2515","DOI":"10.1016\/j.jcin.2019.08.025","article-title":"Safety of Paclitaxel-Coated Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease","volume":"12","author":"K Ouriel","year":"2019","journal-title":"JACC Cardiovasc Interv"},{"issue":"6","key":"pone.0275888.ref067","doi-asserted-by":"crossref","first-page":"783","DOI":"10.1177\/1526602817725062","article-title":"Short-term Results of the RAPID Randomized Trial of the Legflow Paclitaxel-Eluting Balloon With Supera Stenting vs Supera Stenting Alone for the Treatment of Intermediate and Long Superficial Femoral Artery Lesions","volume":"24","author":"SW de Boer","year":"2017","journal-title":"J Endovasc Ther"},{"issue":"12","key":"pone.0275888.ref068","doi-asserted-by":"crossref","first-page":"1102","DOI":"10.1161\/CIRCULATIONAHA.117.028893","article-title":"Stellarex Drug-Coated Balloon for Treatment of Femoropopliteal Disease: Twelve-Month Outcomes From the Randomized ILLUMENATE Pivotal and Pharmacokinetic Studies","volume":"136","author":"P Krishnan","year":"2017","journal-title":"Circulation"},{"key":"pone.0275888.ref069","unstructured":"FDA. Summary of safety and effectiveness data (SSED, P190019B) In: FDA, editor.: FDA; 2019."},{"issue":"23","key":"pone.0275888.ref070","doi-asserted-by":"crossref","first-page":"2357","DOI":"10.1016\/j.jcin.2018.08.034","article-title":"Sustainable Antirestenosis Effect With a Low-Dose Drug-Coated Balloon: The ILLUMENATE European Randomized Clinical Trial 2-Year Results","volume":"11","author":"M Brodmann","year":"2018","journal-title":"JACC Cardiovasc Interv"},{"issue":"24","key":"pone.0275888.ref071","doi-asserted-by":"crossref","first-page":"2417","DOI":"10.1016\/j.jacc.2013.03.034","article-title":"Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: 2-year follow-up from the Zilver PTX randomized and single-arm clinical studies","volume":"61","author":"MD Dake","year":"2013","journal-title":"J Am Coll Cardiol"},{"issue":"2","key":"pone.0275888.ref072","doi-asserted-by":"crossref","first-page":"145","DOI":"10.1056\/NEJMoa1406235","article-title":"Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease","volume":"373","author":"K Rosenfield","year":"2015","journal-title":"N Engl J Med"},{"key":"pone.0275888.ref073","article-title":"Twelve-Month Results From the First-in-China Prospective, Multi-Center, Randomized, Controlled Study of the FREEWAY Paclitaxel-Coated Balloon for Femoropopliteal Treatment","volume":"8","author":"B Zhang","year":"2021","journal-title":"Frontiers in Cardiovascular Medicine"},{"issue":"7","key":"pone.0275888.ref074","doi-asserted-by":"crossref","first-page":"1008","DOI":"10.1007\/s00270-018-1940-1","article-title":"Two-Year Clinical Outcomes of the CONSEQUENT Trial: Can Femoropopliteal Lesions be Treated with Sustainable Clinical Results that are Economically Sound?","volume":"41","author":"T Albrecht","year":"2018","journal-title":"Cardiovasc Intervent Radiol"},{"issue":"7","key":"pone.0275888.ref075","doi-asserted-by":"crossref","first-page":"949","DOI":"10.1007\/s00270-019-02194-w","article-title":"Two-Year Mortality After Angioplasty of the Femoro-Popliteal Artery with Uncoated Balloons and Paclitaxel-Coated Balloons-A Pooled Analysis of Four Randomized Controlled Multicenter Trials","volume":"42","author":"T Albrecht","year":"2019","journal-title":"Cardiovasc Intervent Radiol"},{"issue":"24","key":"pone.0275888.ref076","doi-asserted-by":"crossref","first-page":"2528","DOI":"10.1016\/j.jcin.2019.09.028","article-title":"Bayes Factor Meta-Analysis of the Mortality Claim for Peripheral Paclitaxel-Eluting Devices","volume":"12","author":"JA Bittl","year":"2019","journal-title":"JACC Cardiovasc Interv"},{"issue":"23","key":"pone.0275888.ref077","doi-asserted-by":"crossref","first-page":"1859","DOI":"10.1161\/CIRCULATIONAHA.119.044697","article-title":"Mortality and Paclitaxel-Coated Devices: An Individual Patient Data Meta-Analysis","volume":"141","author":"KJ Rocha-Singh","year":"2020","journal-title":"Circulation"},{"issue":"20","key":"pone.0275888.ref078","doi-asserted-by":"crossref","first-page":"2550","DOI":"10.1016\/j.jacc.2019.01.013","article-title":"Mortality Not Correlated With Paclitaxel Exposure","volume":"73","author":"PA Schneider","year":"2019","journal-title":"Journal of the American College of Cardiology"},{"issue":"5","key":"pone.0275888.ref079","doi-asserted-by":"crossref","first-page":"755","DOI":"10.1177\/15266028211023505","article-title":"Mortality Rates After Paclitaxel-Coated Device Use in Patients With Occlusive Femoropopliteal Disease: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials","volume":"28","author":"K Dinh","year":"2021","journal-title":"Journal of Endovascular Therapy"},{"issue":"2","key":"pone.0275888.ref080","doi-asserted-by":"crossref","first-page":"548","DOI":"10.1016\/j.jvs.2020.05.061","article-title":"Increased mortality with paclitaxel-eluting stents is driven by lesion length","volume":"73","author":"A Mathlouthi","year":"2021","journal-title":"Journal of Vascular Surgery"},{"issue":"2","key":"pone.0275888.ref081","doi-asserted-by":"crossref","first-page":"e008528","DOI":"10.1161\/CIRCINTERVENTIONS.119.008528","article-title":"Mortality After Paclitaxel Coated Balloon Angioplasty and Stenting of Superficial Femoral and Popliteal Artery in the Vascular Quality Initiative","volume":"13","author":"DJ Bertges","year":"2020","journal-title":"Circ Cardiovasc Interv"},{"issue":"4","key":"pone.0275888.ref082","doi-asserted-by":"crossref","first-page":"587","DOI":"10.1016\/j.ejvs.2019.12.034","article-title":"Editor\u2019s Choice\u2014Long Term Survival after Femoropopliteal Artery Revascularisation with Paclitaxel Coated Devices: A Propensity Score Matched Cohort Analysis","volume":"59","author":"CA Behrendt","year":"2020","journal-title":"Eur J Vasc Endovasc Surg"},{"issue":"20","key":"pone.0275888.ref083","doi-asserted-by":"crossref","first-page":"2636","DOI":"10.1016\/j.jacc.2019.02.020","article-title":"Drug-Eluting Stent Implantation and Long-Term Survival Following Peripheral Artery Revascularization","volume":"73","author":"EA Secemsky","year":"2019","journal-title":"J Am Coll Cardiol"},{"issue":"4","key":"pone.0275888.ref084","doi-asserted-by":"crossref","first-page":"332","DOI":"10.1001\/jamacardio.2019.0325","article-title":"Association of Survival With Femoropopliteal Artery Revascularization With Drug-Coated Devices","volume":"4","author":"EA Secemsky","year":"2019","journal-title":"JAMA Cardiol"},{"issue":"12","key":"pone.0275888.ref085","doi-asserted-by":"crossref","first-page":"1889","DOI":"10.1007\/s00270-020-02651-x","article-title":"Safety of Paclitaxel-Eluting Stents in Below-the-Knee Arteries for Critical Limb Ischemia Treatment: the Devil is in the Details","volume":"43","author":"K Katsanos","year":"2020","journal-title":"CardioVascular and Interventional Radiology"},{"issue":"2","key":"pone.0275888.ref086","doi-asserted-by":"crossref","first-page":"265","DOI":"10.1016\/j.ejvs.2019.10.002","article-title":"Editor\u2019s Choice\u2013Drug Coated Balloon Angioplasty vs. Standard Percutaneous Transluminal Angioplasty in Below the Knee Peripheral Arterial Disease: A Systematic Review and Meta-Analysis","volume":"59","author":"J Ipema","year":"2020","journal-title":"European Journal of Vascular and Endovascular Surgery"},{"issue":"2","key":"pone.0275888.ref087","doi-asserted-by":"crossref","first-page":"202","DOI":"10.1016\/j.jvir.2019.11.015","article-title":"Risk of Death and Amputation with Use of Paclitaxel-Coated Balloons in the Infrapopliteal Arteries for Treatment of Critical Limb Ischemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials","volume":"31","author":"K Katsanos","year":"2020","journal-title":"Journal of Vascular and Interventional Radiology"},{"key":"pone.0275888.ref088","doi-asserted-by":"crossref","first-page":"303","DOI":"10.1016\/j.jss.2022.04.055","article-title":"Safety and Efficacy of Drug-Coated Balloon in the Treatment of Below-The-Knee Artery: A Meta-analysis","volume":"278","author":"H Cai","year":"2022","journal-title":"Journal of Surgical Research"}],"container-title":["PLOS ONE"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0275888","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,10,13]],"date-time":"2022-10-13T13:32:26Z","timestamp":1665667946000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0275888"}},"subtitle":[],"editor":[{"given":"Salvatore","family":"De Rosa","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2022,10,13]]},"references-count":88,"journal-issue":{"issue":"10","published-online":{"date-parts":[[2022,10,13]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0275888","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,10,13]]}}}