Charlott Fuß, Hans Krankenberg, Pawel Aftanski, P Christian Schulze, Marcus Thieme
{"title":"Clinical benefits of paclitaxel-coated balloons in the treatment of infrapopliteal limb-threatening peripheral artery disease.","authors":"Charlott Fuß, Hans Krankenberg, Pawel Aftanski, P Christian Schulze, Marcus Thieme","doi":"10.1024/0301-1526/a001217","DOIUrl":null,"url":null,"abstract":"<p><p><b></b> <i>Background:</i> Infrapopliteal lesions account for one-third of peripheral artery disease (PAD) cases; however, its endovascular treatment data are insufficient. Although paclitaxel-coated drug-coated-balloons (DCBs) reduce restenosis and the need for re-interventions in femoropopliteal arteries, their effectiveness in below-the-knee (BTK) vessels is uncertain. This study evaluated the real-world effectiveness and safety of paclitaxel-coated DCBs in BTK vessels. <i>Patients and methods:</i> This retrospective single-centre study included consecutive patients treated with paclitaxel-coated Luminor™ DCB in BTK arteries between August 2017 and March 2022. The follow-up extended to 60 months. Data were retrieved from archives, phone interviews and physician inquiries. <i>Results:</i> Seventy-nine patients (65.5% male; mean age 74.9±9.2 years) underwent 84 interventions with 114 DCBs. The overall and treated lesion lengths averaged 102.1±80.3 and 117.2±75.5 mm, respectively. The median preoperative Rutherford score was 5 [interquartile range (IQR), 5-5; n=80]. The ankle-brachial index (ABI, 0.8±0.4-1.0±0.2, P=.002) and toe-brachial index (TBI, 0.3±0.3-0.6±0.2, P=.039) significantly improved post-intervention. The wound, ischaemia and foot infection score components showed median value reductions from the pre- to the postinterventional assessment: wound, from 1 (IQR, 1-2) to 1 (0-1); ischaemia, from 1 (IQR, 0-2) to 0 (0-1); and foot infection, from 1 (IQR, 0-2) to 0 (0-1). Kaplan-Meier analysis revealed 25 major adverse limb events, 17 re-interventions, 15 major adverse cardiac events, and 8 major amputation events over 5 years. Re-intervention-free survival was lower in men than in women (P=.036). Diabetic status or renal function was not significantly different. The 3-year mortality was 46.4%. <i>Conclusions:</i> This study highlights the clinical benefit of infrapopliteal paclitaxel-coated DCBs in real-world patients. ABI and TBI improvements reflect ischaemia relief. Wound-healing trends suggest reduced ischaemia and infection within 3 days, but requires longer follow-up. High mortality rates emphasise the effect of comorbidities and multidisciplinary care requirements.</p>","PeriodicalId":23528,"journal":{"name":"Vasa-european Journal of Vascular Medicine","volume":" ","pages":""},"PeriodicalIF":2.4000,"publicationDate":"2025-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Vasa-european Journal of Vascular Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1024/0301-1526/a001217","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PERIPHERAL VASCULAR DISEASE","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Infrapopliteal lesions account for one-third of peripheral artery disease (PAD) cases; however, its endovascular treatment data are insufficient. Although paclitaxel-coated drug-coated-balloons (DCBs) reduce restenosis and the need for re-interventions in femoropopliteal arteries, their effectiveness in below-the-knee (BTK) vessels is uncertain. This study evaluated the real-world effectiveness and safety of paclitaxel-coated DCBs in BTK vessels. Patients and methods: This retrospective single-centre study included consecutive patients treated with paclitaxel-coated Luminor™ DCB in BTK arteries between August 2017 and March 2022. The follow-up extended to 60 months. Data were retrieved from archives, phone interviews and physician inquiries. Results: Seventy-nine patients (65.5% male; mean age 74.9±9.2 years) underwent 84 interventions with 114 DCBs. The overall and treated lesion lengths averaged 102.1±80.3 and 117.2±75.5 mm, respectively. The median preoperative Rutherford score was 5 [interquartile range (IQR), 5-5; n=80]. The ankle-brachial index (ABI, 0.8±0.4-1.0±0.2, P=.002) and toe-brachial index (TBI, 0.3±0.3-0.6±0.2, P=.039) significantly improved post-intervention. The wound, ischaemia and foot infection score components showed median value reductions from the pre- to the postinterventional assessment: wound, from 1 (IQR, 1-2) to 1 (0-1); ischaemia, from 1 (IQR, 0-2) to 0 (0-1); and foot infection, from 1 (IQR, 0-2) to 0 (0-1). Kaplan-Meier analysis revealed 25 major adverse limb events, 17 re-interventions, 15 major adverse cardiac events, and 8 major amputation events over 5 years. Re-intervention-free survival was lower in men than in women (P=.036). Diabetic status or renal function was not significantly different. The 3-year mortality was 46.4%. Conclusions: This study highlights the clinical benefit of infrapopliteal paclitaxel-coated DCBs in real-world patients. ABI and TBI improvements reflect ischaemia relief. Wound-healing trends suggest reduced ischaemia and infection within 3 days, but requires longer follow-up. High mortality rates emphasise the effect of comorbidities and multidisciplinary care requirements.
期刊介绍:
Vasa is the European journal of vascular medicine. It is the official organ of the German, Swiss, and Slovenian Societies of Angiology.
The journal publishes original research articles, case reports and reviews on vascular biology, epidemiology, prevention, diagnosis, medical treatment and interventions for diseases of the arterial circulation, in the field of phlebology and lymphology including the microcirculation, except the cardiac circulation.
Vasa combines basic science with clinical medicine making it relevant to all physicians interested in the whole vascular field.