帕克利塔塞尔涂层与未涂层的器件用于间歇性关节病患者的内血管回血 (SWEDEPAD 2):多中心,参与者掩盖,基于注册的随机对照试验
Joakim Nordanstig1, Stefan James2, Manne Andersson3
1Department of Molecular and Clinical Medicine, Institute of Medicine, University of Gothenburg, Gothenburg, Sweden.
Lancet (London, England)
|September 3, 2025
概括
用帕克利塔塞尔涂层的设备没有改善经过重血管化的外周动脉疾病患者的生活质量. 虽然整体死亡率相似,但涂层设备的5年死亡率更高,质疑它们的常规使用.
科学领域:
- 血管外科
- 干预心脏病学
- 医疗器械
背景情况:
- 周围动脉疾病 (PAD) 影响下肢的血液循环,通常需要重新血管.
- 药物涂层的装置用于防止静脉缩,但它们对患者的结果的影响仍有争议.
- 间歇性是PAD的常见症状,影响生活质量.
研究的目的:
- 评估帕克利塔塞尔涂层设备与未涂层设备对以患者为中心的PAD结果的影响.
- 评估经过内内血管再循环治疗的患者对生活质量 (QoL) 和死亡率的影响.
- 为了确定药物释放技术是否能提供除了预防缩之外的好处.
主要方法:
- 在瑞典进行实用性的全国性基于注册的随机对照试验 (SWEDEPAD 2).
- 随机分配1155名患有间歇性硬化 (Rutherford 1- 3) 的成年患者使用包甲或不包甲的装置.
- 主要终点是使用血管生活质量问卷 (VascuQoL-6) 的1年后的QOL.
主要成果:
- 包利塔塞尔涂层和未涂层组在1年后的VascuQoL-6得分没有显著差异 (p=0. 96).
- 在平均7. 1年的随访期间,所有原因的总死亡率都没有显著差异 (HR 1. 18; p=0. 16).
- 帕克利塔塞尔涂层器件组的5年死亡率明显较高 (每100人/ 年4. 57对3. 28; p=0. 010).
结论:
- 在经过内内血管再循环的PAD患者中,包利塔塞尔涂层器件在1年内没有改善疾病特异性生活质量.
- 虽然整体死亡率相似,但帕克利塔塞尔涂层器件的5年死亡率出现了令人担忧的趋势.
- 这些发现不支持在该患者群体中常规使用包利塔塞尔涂层设备.
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