{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,16]],"date-time":"2026-02-16T09:09:58Z","timestamp":1771232998835,"version":"3.50.1"},"reference-count":31,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2020,8,24]],"date-time":"2020-08-24T00:00:00Z","timestamp":1598227200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004374","name":"Medtronic","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004374","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2020,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Paclitaxel drug\u2010coated balloons (DCB) prevent recurrent claudication after angioplasty, yet data from randomized trials with incomplete follow\u2010up have raised uncertainty regarding long\u2010term mortality.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objectives<\/jats:title><jats:p>To evaluate the effect of paclitaxel exposure on the long\u2010term safety and efficacy of angioplasty of femoropopliteal artery lesions in the combined IN.PACT randomized trials.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The IN.PACT randomized trials (SFA, <jats:italic>N<\/jats:italic> =\u2009331 and Japan, <jats:italic>N<\/jats:italic> =\u2009100) each compared the DCB with standard percutaneous transluminal angioplasty (PTA) for claudication, and consented patients for 5 and 3\u2009years, respectively. To address long\u2010term safety, sites were requested to obtain vital status follow\u2010up. In the pooled, updated data set, we examined the association between randomized treatment and mortality by cumulative incidence and hazard ratio (HR), and freedom from clinically driven target lesion revascularization (CD\u2010TLR). Multivariable Cox regression with adjustment for baseline characteristics was used to evaluate the dose effect. Causes of death were adjudicated by a blinded clinical events committee that included oncologists with paclitaxel expertise.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The rate of long\u2010term vital status ascertainment increased from 81% to 97% for DCB and from 85% to 97% for PTA in the IN.PACT SFA trial. The cumulative incidence of mortality was 14.7% DCB versus 12.0% PTA at 5\u2009years, HR 1.39, log\u2010rank <jats:italic>p<\/jats:italic> =\u2009.286. Paclitaxel dose (mg) was not an independent predictor of mortality (HR 1.02, <jats:italic>p<\/jats:italic> =\u2009.381), but was an independent predictor of reduced risk of CD\u2010TLR (HR 0.79; <jats:italic>p<\/jats:italic> &lt;\u2009.001). Causes of death did not differ by treatment arm.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>In pooled randomized trial data with updated vital status ascertainment, paclitaxel was associated with improved efficacy but was not associated with increased mortality.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.29152","type":"journal-article","created":{"date-parts":[[2020,8,24]],"date-time":"2020-08-24T18:59:08Z","timestamp":1598295548000},"page":"1087-1099","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":22,"title":["Paclitaxel exposure: Long\u2010term safety and effectiveness of a <scp>drug\u2010coated<\/scp> balloon for claudication in pooled randomized trials"],"prefix":"10.1002","volume":"96","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4498-5150","authenticated-orcid":false,"given":"Peter A.","family":"Schneider","sequence":"first","affiliation":[{"name":"Division of Vascular and Endovascular Surgery University of California at San Francisco  San Francisco California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6493-3799","authenticated-orcid":false,"given":"Marianne","family":"Brodmann","sequence":"additional","affiliation":[{"name":"Division of Angiology Medical University Graz  Graz Austria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura","family":"Mauri","sequence":"additional","affiliation":[{"name":"Medtronic Inc.  Minneapolis Minnesota"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Laird","sequence":"additional","affiliation":[{"name":"Adventist Heart and Vascular Institute  St. Helena California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoshimitsu","family":"Soga","sequence":"additional","affiliation":[{"name":"Kokura Memorial Hospital  Fukuoka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Antonio","family":"Micari","sequence":"additional","affiliation":[{"name":"Humanitas Gavazzeni Hospital  Bergamo Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gary","family":"Ansel","sequence":"additional","affiliation":[{"name":"Ohio Health Riverside Methodist Hospital  Columbus Ohio"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mehdi H.","family":"Shishehbor","sequence":"additional","affiliation":[{"name":"Heart and Vascular Institute University Hospitals Cleveland Medical Center, Case Western Reserve University School of Medicine  Cleveland Ohio"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Prakash","family":"Krishnan","sequence":"additional","affiliation":[{"name":"The Mount Sinai Hospital  New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qi","family":"Gao","sequence":"additional","affiliation":[{"name":"Baim Institute for Clinical Research  Boston Massachusetts"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kenneth","family":"Ouriel","sequence":"additional","affiliation":[{"name":"Syntactx  New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Zeller","sequence":"additional","affiliation":[{"name":"Universit\u00e4ts\u2010Herzzentrum Freiburg\u2013Bad Krozingen  Bad Krozingen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,8,24]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa032441"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.0000086926.62288.A6"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2011.03.005"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2019.01.080"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.27484"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.114.011004"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1177\/1526602817745565"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.118.007702"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1161\/JAHA.118.011245"},{"key":"e_1_2_10_11_1","volume-title":"The Food and Drug Administration Executive Summary: Circulatory System Devices Panel Meeting","author":"U.S. Food and Drug Administration"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2017.12.048"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2019.01.013"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1517\/14656566.3.6.755"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2015.09.063"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.117.005891"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-1-4684-6265-4"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2013.11.063"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.2215\/CJN.04411007"},{"key":"e_1_2_10_20_1","unstructured":"MayerEL. Use of paclitaxel as a primary therapy in oncology: outcomes benefits adverse events and doses compared to devices. Presented at: the VIVA: Vascular Leaders Forum meeting; February2019; Washington DC."},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(04)01466-4"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamacardio.2019.0325"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2019.04.106"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00270-019-02329-z"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehz698"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2019.10.100"},{"key":"e_1_2_10_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejvs.2019.12.034"},{"key":"e_1_2_10_28_1","doi-asserted-by":"publisher","DOI":"10.1177\/1526602820904783"},{"key":"e_1_2_10_29_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00270-019-02324-4"},{"key":"e_1_2_10_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2019.08.025"},{"key":"e_1_2_10_31_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.119.040518"},{"key":"e_1_2_10_32_1","article-title":"Two\u2010year mortality after angioplasty of the femoro\u2010popliteal artery with uncoated balloons and paclitaxel\u2010coated balloons\u2010a pooled analysis of four randomized controlled Multicenter trials","volume":"42","author":"Albrecht T","year":"2019","journal-title":"Cardiovasc Intervent Radiol"}],"container-title":["Catheterization and Cardiovascular Interventions"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ccd.29152","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/ccd.29152","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ccd.29152","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,4]],"date-time":"2023-09-04T05:59:30Z","timestamp":1693807170000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/ccd.29152"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,8,24]]},"references-count":31,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2020,11]]}},"alternative-id":["10.1002\/ccd.29152"],"URL":"https:\/\/doi.org\/10.1002\/ccd.29152","archive":["Portico"],"relation":{},"ISSN":["1522-1946","1522-726X"],"issn-type":[{"value":"1522-1946","type":"print"},{"value":"1522-726X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,8,24]]},"assertion":[{"value":"2020-06-04","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-07-03","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-08-24","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}