{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,25]],"date-time":"2026-03-25T20:37:33Z","timestamp":1774471053611,"version":"3.50.1"},"reference-count":16,"publisher":"MDPI AG","issue":"16","license":[{"start":{"date-parts":[[2021,8,23]],"date-time":"2021-08-23T00:00:00Z","timestamp":1629676800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>This study used independent, real-world, patient-level data to examine whether the dosage or frequency of paclitaxel exposure correlated with mortality during follow up. We conducted a retrospective analysis of patients treated with a drug-coated balloon (DCB) for an atherosclerotic femoropopliteal lesion from February 2013 to December 2018, excluding patients with non-atherosclerotic lesions or restenosis after DCB treatment in another hospital. We investigated the causes of death, comorbidities (including cancer status), and the initial and total cumulative dosages and frequency of paclitaxel use. To determine whether the dosage or frequency of paclitaxel exposure affected mortality during follow up, we analyzed the risk factors for all-cause death by conducting a time-dependent Cox regression analysis that considered demographics, comorbidities, lesion and procedural characteristics, and paclitaxel exposure data (dosage and frequency). Our analysis examined 225 patients (mean age 71 \u00b1 9 years, range 38\u201393 years, male 81%). During a mean follow-up duration of 35 months (range 1\u201389 months), 56 patients (24.9%) died from cardiac disorders (16%, including acute myocardial infarction, heart failure, or sudden cardiac arrest), malignancy (14.3%), respiratory failure with pneumonia (12.5%), septic shock (12.5%), or another cause. Univariable and multivariable Cox regression analyses identified age (hazard ratio, HR, 1.057; 95% confidence interval, CI, 1019\u20131096; p = 0.0032), critical limb ischemia (CLI) (HR, 4135; 95% CI, 2171\u20137876; p &lt; 0.0001), and the total dosage of paclitaxel (mg) (HR, 1.040; 95% CI, 1006\u20131074; p = 0.0210) as predictors of mortality during follow up. The subgroup analysis found that the total dosage of paclitaxel (mg) was also a predictor of mortality during follow up in the CLI group (HR, 1.046; 95% CI, 1007\u20131087, p = 0.0198). The estimated cut-off value of total cumulative paclitaxel dosage for predicting mortality was 12 mg as evaluated by minimum p value approach. This patient-level analysis identified the total cumulative dosage of paclitaxel as a predictor of mortality after the use of paclitaxel-coated balloons. Our results provide limited information about the potential dose\u2013response relationship underlying paclitaxel-associated mortality concerns.<\/jats:p>","DOI":"10.3390\/jcm10163747","type":"journal-article","created":{"date-parts":[[2021,8,23]],"date-time":"2021-08-23T10:24:17Z","timestamp":1629714257000},"page":"3747","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Mortality after Use of Paclitaxel-Coated Balloons Correlates with Total Cumulative Dosage of Paclitaxel in Real-World Analysis"],"prefix":"10.3390","volume":"10","author":[{"given":"Seon-Hee","family":"Heo","sequence":"first","affiliation":[{"name":"Department of Surgery, Yonsei University College of Medicine, Seoul 03722, Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shin-Young","family":"Woo","sequence":"additional","affiliation":[{"name":"Vascular Surgery, Department of Surgery, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Seung-Hyuk","family":"Choi","sequence":"additional","affiliation":[{"name":"Intervention Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Taek-Kyu","family":"Park","sequence":"additional","affiliation":[{"name":"Intervention Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Young-Soo","family":"Do","sequence":"additional","affiliation":[{"name":"Department of Radiology and Center for Imaging Science, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kwang-Bo","family":"Park","sequence":"additional","affiliation":[{"name":"Department of Radiology and Center for Imaging Science, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dong-Ik","family":"Kim","sequence":"additional","affiliation":[{"name":"Vascular Surgery, Department of Surgery, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Young-Wook","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Surgery, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul 03181, Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yang-Jin","family":"Park","sequence":"additional","affiliation":[{"name":"Vascular Surgery, Department of Surgery, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2021,8,23]]},"reference":[{"key":"ref_1","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":"Rosenfield","year":"2015","journal-title":"N. Engl. J. Med."},{"key":"ref_2","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":"Katsanos","year":"2018","journal-title":"J. Am. Heart Assoc."},{"key":"ref_3","unstructured":"Food and Drug Administration (2020, January 01). Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality\u2013Letter to Health Care Providers (7 August 2019UPDATE), Available online: www.fda.gov\/medical-devices\/letters-health-care-providers\/update-treatment-peripheral-arterial-disease-paclitaxel-coated-balloons-and-paclitaxel-eluting."},{"key":"ref_4","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":"Nordanstig","year":"2020","journal-title":"N. Engl. J. Med."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"2550","DOI":"10.1016\/j.jacc.2019.01.013","article-title":"Mortality Not Correlated With Paclitaxel Exposure: An Independent Patient-Level Meta-Analysis of a Drug-Coated Balloon","volume":"73","author":"Schneider","year":"2019","journal-title":"J. Am. Coll. Cardiol."},{"key":"ref_6","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":"Secemsky","year":"2019","journal-title":"JAMA Cardiol."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"587","DOI":"10.1016\/j.ejvs.2019.12.034","article-title":"Editor\u2019s Choice\u2013Long Term Survival after Femoropopliteal Artery Revascularisation with Paclitaxel Coated Devices: A Propensity Score Matched Cohort Analysis","volume":"59","author":"Behrendt","year":"2020","journal-title":"Eur. J. Vasc. Endovasc. Surg."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"3732","DOI":"10.1093\/eurheartj\/ehz698","article-title":"Mortality after use of paclitaxel-based devices in peripheral arteries: A real-world safety analysis","volume":"41","author":"Freisinger","year":"2020","journal-title":"Eur. Hearth J."},{"key":"ref_9","first-page":"295","article-title":"The environment and disease: Association or causation?","volume":"58","author":"Hill","year":"1965","journal-title":"Proc. R. Soc. Med."},{"key":"ref_10","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":"Duval","year":"2020","journal-title":"Circulation"},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"1950","DOI":"10.1016\/j.jvs.2019.03.072","article-title":"Clinical outcome of drug-coated balloon angioplasty in patients with femoropopliteal disease: A real-world single-center experience","volume":"70","author":"AbuRahma","year":"2019","journal-title":"J. Vasc. Surg."},{"key":"ref_12","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":"Katsanos","year":"2020","journal-title":"J. Vasc. Interv. Radiol."},{"key":"ref_13","doi-asserted-by":"crossref","unstructured":"Katsanos, K., Spiliopoulos, S., Teichgr\u00e4ber, U., Kitrou, P., Del Giudice, C., Bj\u00f6rkman, P., Bisdas, T., de Boer, S., Krokidis, M., and Karnabatidis, D. (2021). Risk of major amputation following application of paclitaxel coated balloons in the lower limb arteries: A systematic review and meta-analysis of randomised controlled trials. Eur. J. Vasc. Endovasc. Surg., in press.","DOI":"10.1016\/j.jvs.2021.12.018"},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"e005654","DOI":"10.1161\/CIRCINTERVENTIONS.117.005654","article-title":"IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease","volume":"11","author":"Scheinert","year":"2018","journal-title":"Circ. Cardiovasc. Interv."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"2113","DOI":"10.1016\/j.jcin.2017.06.018","article-title":"IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The IN.PACT Global Study De Novo In-Stent Restenosis Imaging Cohort","volume":"10","author":"Brodmann","year":"2017","journal-title":"JACC Cardiovasc. Interv."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"1682","DOI":"10.1016\/j.jcin.2017.04.041","article-title":"The 24-Month Results of the Lutonix Global SFA Registry: Worldwide Experience With Lutonix Drug-Coated Balloon","volume":"10","author":"Thieme","year":"2017","journal-title":"JACC Cardiovasc. Interv."}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/10\/16\/3747\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T06:49:50Z","timestamp":1760165390000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/10\/16\/3747"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,8,23]]},"references-count":16,"journal-issue":{"issue":"16","published-online":{"date-parts":[[2021,8]]}},"alternative-id":["jcm10163747"],"URL":"https:\/\/doi.org\/10.3390\/jcm10163747","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,8,23]]}}}