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血栓形成后综合征静脉支架置入的临床试验:现状及与大流行相关的变化

A Clinical Trial of Venous Stent Placement for Post-thrombotic Syndrome: Current Status and Pandemic-related Changes.

作者信息

Vedantham Suresh, Parpia Sameer, Kahn Susan R

机构信息

Mallinckrodt Institute of Radiology, Washington University School of Medicine, St Louis, MO, US.

Departments of Oncology, and Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.

出版信息

Vasc Endovasc Rev. 2022 Feb;5. doi: 10.15420/ver.2021.19. Epub 2022 Jun 21.

Abstract

Patients with post-thrombotic syndrome (PTS) and iliac vein obstruction have lower extremity symptoms, activity limitation and impairment of health-related quality of life. Preliminary studies suggest that iliac vein stent placement, which eliminates venous outflow obstruction, may reduce the clinical severity of PTS. However, stent placement is associated with patient risk, inconvenience and cost. Therefore, the Chronic Venous Thrombosis - Relief with Adjunctive Catheter-directed Therapy (C-TRACT) trial was launched to rigorously assess the risk-benefit ratio of stent placement for the treatment of moderate or severe PTS. In the trial, patients in both treatment groups receive a high quality of multimodality PTS care that includes medical, compressive, and ulcer therapies. Due to the COVID-19 pandemic, the trial protocol and practices were modified to enhance the study feasibility while preserving its ability to answer its primary question. This review summarises the current status of the trial and the potential impact of the pandemic-related adaptations to future venous clinical practice and research.

摘要

患有血栓后综合征(PTS)和髂静脉阻塞的患者存在下肢症状、活动受限以及健康相关生活质量受损的情况。初步研究表明,消除静脉流出道阻塞的髂静脉支架置入术可能会降低PTS的临床严重程度。然而,支架置入术与患者风险、不便和成本相关。因此,开展了慢性静脉血栓形成——辅助导管定向治疗缓解(C-TRACT)试验,以严格评估支架置入术治疗中度或重度PTS的风险效益比。在该试验中,两个治疗组的患者都接受高质量的多模式PTS护理,包括药物治疗、压迫治疗和溃疡治疗。由于新冠疫情,试验方案和做法进行了修改,以提高研究的可行性,同时保持其回答主要问题的能力。本综述总结了该试验的现状以及与疫情相关的调整对未来静脉临床实践和研究的潜在影响。

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