國家衛生研究院 NHRI:Item 3990099045/15011
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    题名: A randomised trial comparing drug-coated balloons and conventional balloons for the treatment of stent-graft stenosis in dialysis vascular access
    作者: Hsieh, MY;Lin, PS;Liao, MT;Lin, L;Chen, TY;Boon, JC;Yang, TF;Wu, CC
    贡献者: Institute of Cellular and Systems Medicine
    摘要: OBJECTIVE: Previous studies on arteriovenous fistulas have demonstrated the potential benefit of drug-coated balloons (DCBs) in maintaining the patency of dialysis access. However, stenoses involving stent-grafts were excluded from these studies. Therefore, we aimed to evaluate the effectiveness of DCBs in treating stent-graft stenosis. METHODS: This was a prospective, single-blinded, randomised controlled study. From March 2017 to April 2021, 40 patients with dysfunctional vascular access owing to stent-graft stenosis were randomised to treatment with a DCB or a conventional balloon. Clinical follow up was scheduled at 1, 3, and 6 months, and angiographic follow up was performed 6 months after the intervention. The primary outcome was angiographic late luminal loss at 6 months, and secondary outcomes included target lesion and access circuit primary patency at 6 months. RESULTS: Thirty-six participants completed follow up angiography. The DCB group had a superior mean late luminal loss at 6 months compared with the control group (1.82 mm ± 1.83 mm vs. 3.63 mm ± 1.08 mm, respectively, p = .001). All 40 patients completed clinical follow up. The DCB group had a superior 6-month target lesion primary patency compared with the control group [hazard ratio (HR) 0.23, 95% confidence interval (CI) 0.07 - 0.71; p = .005). Additionally, the DCB group had a numerically higher 6-month access circuit primary patency rate than the control group, although the difference was not statistically significant (HR 0.54, 95% CI 0.26 - 1.11, p = .095). CONCLUSION: Conventional balloon angioplasty is not durable in stent-graft stenosis treatment. Treatment with DCBs provides less angiographic late luminal loss and potentially superior primary patency of the target lesion than treatment with conventional balloons. [ClinicalTrials ID: NCT03360279.].
    日期: 2023-08
    關聯: European Journal of Vascular and Endovascular Surgery. 2023 Aug;66(2):253-260.
    Link to: http://dx.doi.org/10.1016/j.ejvs.2023.05.028
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=1078-5884&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:001059000900001
    Cited Times(Scopus): https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85164376608
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