{"title":"Outcomes After Paclitaxel Coated Device Use in Patients with Peripheral Artery Disease: A Nationwide Population Based Study.","authors":"Chen-Yu Huang, Jen-Kuang Lee, Hsu-Ping Wu, Wen-Jung Chung, Shu-Kai Hsueh, Po-Chao Hsu, Chun-Chi Chen, Chi-Hung Huang, Hsuan-Li Huang","doi":"10.1016/j.ejvs.2025.02.002","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>A summary level meta-analysis showed increased mortality beyond the first year following revascularisation with paclitaxel coated devices (PCDs) in patients with peripheral artery disease. However, these findings remain controversial. This study aimed to provide a real world analysis on the safety of PCDs.</p><p><strong>Methods: </strong>A nationwide, exhaustive retrospective cohort study was conducted using administrative medical data from the National Health Insurance Research Database in Taiwan. A total of 19 612 patients receiving lower limb endovascular revascularisation from May 2016 to December 2019 were analysed. All cause death, limb outcome, and cardiovascular (CV) outcome in the propensity matched cohort were assessed. Limb outcome was the composite of new onset chronic limb threatening ischaemia or amputation. Cardiovascular outcomes included CV death, non-fatal ischaemic stroke, non-fatal myocardial infarction, or heart failure (HF) hospitalisation.</p><p><strong>Results: </strong>Over a median of 14.2 months, all cause death occurred in 535 of 2 205 patients (24.3%) receiving PCDs and 1 398 of 4 410 (31.7%) receiving non-PCDs (subdistribution hazard ratio [sHR] 0.71; 95% confidence interval [CI] 0.64 - 0.78). Composite limb outcome occurred in 622 patients (28.2%) in the PCD group and in 1 174 patients (26.6%) in the non-PCD group (sHR 0.98; 95% CI 0.89 - 1.08). Composite CV outcome was less frequent in patients receiving PCD (20.1%) vs. control (23.3 %) (sHR 0.79; 95% CI 0.71 - 0.88).</p><p><strong>Conclusion: </strong>In patients receiving endovascular revascularisation, exposure to a PCD was associated with lower risk of all cause death and composite CV outcome. No difference in composite limb outcome was found.</p>","PeriodicalId":55160,"journal":{"name":"European Journal of Vascular and Endovascular Surgery","volume":" ","pages":""},"PeriodicalIF":5.7000,"publicationDate":"2025-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Journal of Vascular and Endovascular Surgery","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.ejvs.2025.02.002","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PERIPHERAL VASCULAR DISEASE","Score":null,"Total":0}
引用次数: 0
Abstract
Objective: A summary level meta-analysis showed increased mortality beyond the first year following revascularisation with paclitaxel coated devices (PCDs) in patients with peripheral artery disease. However, these findings remain controversial. This study aimed to provide a real world analysis on the safety of PCDs.
Methods: A nationwide, exhaustive retrospective cohort study was conducted using administrative medical data from the National Health Insurance Research Database in Taiwan. A total of 19 612 patients receiving lower limb endovascular revascularisation from May 2016 to December 2019 were analysed. All cause death, limb outcome, and cardiovascular (CV) outcome in the propensity matched cohort were assessed. Limb outcome was the composite of new onset chronic limb threatening ischaemia or amputation. Cardiovascular outcomes included CV death, non-fatal ischaemic stroke, non-fatal myocardial infarction, or heart failure (HF) hospitalisation.
Results: Over a median of 14.2 months, all cause death occurred in 535 of 2 205 patients (24.3%) receiving PCDs and 1 398 of 4 410 (31.7%) receiving non-PCDs (subdistribution hazard ratio [sHR] 0.71; 95% confidence interval [CI] 0.64 - 0.78). Composite limb outcome occurred in 622 patients (28.2%) in the PCD group and in 1 174 patients (26.6%) in the non-PCD group (sHR 0.98; 95% CI 0.89 - 1.08). Composite CV outcome was less frequent in patients receiving PCD (20.1%) vs. control (23.3 %) (sHR 0.79; 95% CI 0.71 - 0.88).
Conclusion: In patients receiving endovascular revascularisation, exposure to a PCD was associated with lower risk of all cause death and composite CV outcome. No difference in composite limb outcome was found.
期刊介绍:
The European Journal of Vascular and Endovascular Surgery is aimed primarily at vascular surgeons dealing with patients with arterial, venous and lymphatic diseases. Contributions are included on the diagnosis, investigation and management of these vascular disorders. Papers that consider the technical aspects of vascular surgery are encouraged, and the journal includes invited state-of-the-art articles.
Reflecting the increasing importance of endovascular techniques in the management of vascular diseases and the value of closer collaboration between the vascular surgeon and the vascular radiologist, the journal has now extended its scope to encompass the growing number of contributions from this exciting field. Articles describing endovascular method and their critical evaluation are included, as well as reports on the emerging technology associated with this field.