{"title":"在现实世界实践中，Zilver PTX与Eluvia治疗股腘动脉疾病的一年结果:REALDES研究。","authors":"Tsuyoshi Shibata, Yutaka Iba, Masami Shingaki, Osamu Yamashita, Yoshinori Tsubakimoto, Fumiaki Kimura, Atsutoshi Hatada, Fuminori Kasashima, Kyohei Ueno, Keitaro Nakanishi, Kiyofumi Morishita, Tomohiro Nakajima, Junji Nakazawa, Akihito Ohkawa, Itaru Hosaka, Ayaka Arihara, Shingo Tsushima, Nobuyoshi Kawaharada","doi":"10.1177/15266028231179861","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>This multicenter, prospective, observational study aimed to compare Zilver PTX and Eluvia stents in real-world settings for treating femoropopliteal lesions as the differences in the 1-year outcomes of these stents have not been elucidated.</p><p><strong>Materials and methods: </strong>Overall, 200 limbs with native femoropopliteal artery disease were treated with Zilver PTX (96 limbs) or Eluvia (104 limbs) at 8 Japanese hospitals between February 2019 and September 2020. The primary outcome measure of this study was primary patency at 12 months, defined as a peak systolic velocity ratio of ≤2.4, without clinically-driven target lesion revascularization (TLR) or stenosis ≤50% based on angiographic findings.</p><p><strong>Results: </strong>The baseline clinical and lesion characteristics of Zilver PTX and Eluvia groups were roughly comparable (of all limbs analyzed, approximately 30% presented with critical limb-threatening ischemia, approximately 60% presented with Trans-Atlantic Inter-Society Consensus II C-D, and approximately half had total occlusion), except for the longer lesion lengths in the Zilver PTX group (185.7±92.0 mm vs 160.0±98.5 mm, p=0.030). The Kaplan-Meier estimates of primary patency at 12 months were 84.9% and 88.1% for Zilver PTX and Eluvia, respectively (log-rank p=0.417). Freedom from clinically-driven TLR rates were 88.8% and 90.9% for Zilver PTX and Eluvia, respectively (log-rank p=0.812).</p><p><strong>Conclusions: </strong>The results of the Zilver PTX and Eluvia stents were not different regarding primary patency and freedom from clinically-driven TLR at 12 months after treating patients with femoropopliteal peripheral artery disease in real-world settings.Clinical ImpactThis is the first study to reveal that the Zilver PTX and Eluvia have similar results in real-world practice when the proper vessel preparation is performed. However, the type of restenosis in the Eluvia stent may differ from that in the Zilver PTX stent. Therefore, the results of this study may influence the selection of DES for femoropopliteal lesions in routine clinical practice.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"490-497"},"PeriodicalIF":1.7000,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"One Year Outcomes of Zilver PTX Versus Eluvia for Femoropopliteal Disease in Real-World Practice: REALDES Study.\",\"authors\":\"Tsuyoshi Shibata, Yutaka Iba, Masami Shingaki, Osamu Yamashita, Yoshinori Tsubakimoto, Fumiaki Kimura, Atsutoshi Hatada, Fuminori Kasashima, Kyohei Ueno, Keitaro Nakanishi, Kiyofumi Morishita, Tomohiro Nakajima, Junji Nakazawa, Akihito Ohkawa, Itaru Hosaka, Ayaka Arihara, Shingo Tsushima, Nobuyoshi Kawaharada\",\"doi\":\"10.1177/15266028231179861\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>This multicenter, prospective, observational study aimed to compare Zilver PTX and Eluvia stents in real-world settings for treating femoropopliteal lesions as the differences in the 1-year outcomes of these stents have not been elucidated.</p><p><strong>Materials and methods: </strong>Overall, 200 limbs with native femoropopliteal artery disease were treated with Zilver PTX (96 limbs) or Eluvia (104 limbs) at 8 Japanese hospitals between February 2019 and September 2020. The primary outcome measure of this study was primary patency at 12 months, defined as a peak systolic velocity ratio of ≤2.4, without clinically-driven target lesion revascularization (TLR) or stenosis ≤50% based on angiographic findings.</p><p><strong>Results: </strong>The baseline clinical and lesion characteristics of Zilver PTX and Eluvia groups were roughly comparable (of all limbs analyzed, approximately 30% presented with critical limb-threatening ischemia, approximately 60% presented with Trans-Atlantic Inter-Society Consensus II C-D, and approximately half had total occlusion), except for the longer lesion lengths in the Zilver PTX group (185.7±92.0 mm vs 160.0±98.5 mm, p=0.030). The Kaplan-Meier estimates of primary patency at 12 months were 84.9% and 88.1% for Zilver PTX and Eluvia, respectively (log-rank p=0.417). Freedom from clinically-driven TLR rates were 88.8% and 90.9% for Zilver PTX and Eluvia, respectively (log-rank p=0.812).</p><p><strong>Conclusions: </strong>The results of the Zilver PTX and Eluvia stents were not different regarding primary patency and freedom from clinically-driven TLR at 12 months after treating patients with femoropopliteal peripheral artery disease in real-world settings.Clinical ImpactThis is the first study to reveal that the Zilver PTX and Eluvia have similar results in real-world practice when the proper vessel preparation is performed. However, the type of restenosis in the Eluvia stent may differ from that in the Zilver PTX stent. Therefore, the results of this study may influence the selection of DES for femoropopliteal lesions in routine clinical practice.</p>\",\"PeriodicalId\":50210,\"journal\":{\"name\":\"Journal of Endovascular Therapy\",\"volume\":\" \",\"pages\":\"490-497\"},\"PeriodicalIF\":1.7000,\"publicationDate\":\"2025-04-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Endovascular Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/15266028231179861\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/6/8 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"PERIPHERAL VASCULAR DISEASE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Endovascular Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/15266028231179861","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/6/8 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"PERIPHERAL VASCULAR DISEASE","Score":null,"Total":0}
引用次数: 0
摘要
目的:这项多中心、前瞻性、观察性研究旨在比较Zilver PTX和Eluvia支架在现实环境中治疗股腘动脉病变的效果，因为这两种支架1年预后的差异尚未得到阐明。材料和方法:2019年2月至2020年9月，在日本8家医院接受Zilver PTX(96条肢体)或Eluvia(104条肢体)治疗的200条肢体患有先天性股腘动脉疾病。本研究的主要结局指标是12个月时的原发性通畅，定义为峰值收缩速度比≤2.4，无临床驱动的靶病变血运重建术(TLR)或根据血管造影结果狭窄≤50%。结果:Zilver PTX组和Eluvia组的基线临床和病变特征大致相当(在分析的所有肢体中，约30%出现严重肢体威胁缺血，约60%出现跨大西洋社会共识II C-D，约一半出现全闭塞)，除了Zilver PTX组的病变长度较长(185.7±92.0 mm vs 160.0±98.5 mm, p=0.030)。Kaplan-Meier估计Zilver PTX和Eluvia的12个月原发性通畅率分别为84.9%和88.1% (log-rank p=0.417)。Zilver PTX和Eluvia的临床驱动TLR发生率分别为88.8%和90.9% (log-rank p=0.812)。结论:在现实环境中，在治疗股腘外周动脉疾病患者12个月后，Zilver PTX和Eluvia支架在原发性通畅和免于临床驱动的TLR方面没有差异。临床影响:这是第一次研究表明，当进行适当的血管准备时，Zilver PTX和Eluvia在现实世界的实践中具有相似的结果。然而，Eluvia支架中的再狭窄类型可能与Zilver PTX支架中的再狭窄类型不同。因此，本研究结果可能会影响常规临床中DES治疗股腘动脉病变的选择。
One Year Outcomes of Zilver PTX Versus Eluvia for Femoropopliteal Disease in Real-World Practice: REALDES Study.
Purpose: This multicenter, prospective, observational study aimed to compare Zilver PTX and Eluvia stents in real-world settings for treating femoropopliteal lesions as the differences in the 1-year outcomes of these stents have not been elucidated.
Materials and methods: Overall, 200 limbs with native femoropopliteal artery disease were treated with Zilver PTX (96 limbs) or Eluvia (104 limbs) at 8 Japanese hospitals between February 2019 and September 2020. The primary outcome measure of this study was primary patency at 12 months, defined as a peak systolic velocity ratio of ≤2.4, without clinically-driven target lesion revascularization (TLR) or stenosis ≤50% based on angiographic findings.
Results: The baseline clinical and lesion characteristics of Zilver PTX and Eluvia groups were roughly comparable (of all limbs analyzed, approximately 30% presented with critical limb-threatening ischemia, approximately 60% presented with Trans-Atlantic Inter-Society Consensus II C-D, and approximately half had total occlusion), except for the longer lesion lengths in the Zilver PTX group (185.7±92.0 mm vs 160.0±98.5 mm, p=0.030). The Kaplan-Meier estimates of primary patency at 12 months were 84.9% and 88.1% for Zilver PTX and Eluvia, respectively (log-rank p=0.417). Freedom from clinically-driven TLR rates were 88.8% and 90.9% for Zilver PTX and Eluvia, respectively (log-rank p=0.812).
Conclusions: The results of the Zilver PTX and Eluvia stents were not different regarding primary patency and freedom from clinically-driven TLR at 12 months after treating patients with femoropopliteal peripheral artery disease in real-world settings.Clinical ImpactThis is the first study to reveal that the Zilver PTX and Eluvia have similar results in real-world practice when the proper vessel preparation is performed. However, the type of restenosis in the Eluvia stent may differ from that in the Zilver PTX stent. Therefore, the results of this study may influence the selection of DES for femoropopliteal lesions in routine clinical practice.
期刊介绍：
The Journal of Endovascular Therapy (formerly the Journal of Endovascular Surgery) was established in 1994 as a forum for all physicians, scientists, and allied healthcare professionals who are engaged or interested in peripheral endovascular techniques and technology. An official publication of the International Society of Endovascular Specialists (ISEVS), the Journal of Endovascular Therapy publishes peer-reviewed articles of interest to clinicians and researchers in the field of peripheral endovascular interventions.
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