North Bristol NHS Trust, Bristol, UK; Bristol Centre for Surgical Research, Bristol Medical School, University of Bristol, Bristol, UK.
Bristol Centre for Surgical Research, Bristol Medical School, University of Bristol, Bristol, UK.
Eur J Vasc Endovasc Surg. 2020 Jul;60(1):77-87. doi: 10.1016/j.ejvs.2020.03.010. Epub 2020 Apr 4.
Randomised trials of new devices for peripheral arterial endovascular intervention are published regularly. The evidence for which antiplatelet and/or anticoagulant (antithrombotic) therapy to use after an intervention is lacking. The aim of this systematic review was to examine the antithrombotic regimens in randomised trials for peripheral arterial endovascular intervention to understand choices made and trends with time or type of device.
Data sources were the Medline, Embase, and Cochrane Library databases. Randomised trials including participants with peripheral arterial disease undergoing any endovascular arterial intervention were included. Trial methods were assessed to determine whether an antithrombotic protocol had been specified, its completeness, and the agent(s) prescribed. Antithrombotic therapy protocols were classed as peri-procedural (preceding and during intervention), immediate post-procedural (up to 30 days following intervention), and maintenance post-procedural (therapy continuing beyond 30 days).
Ninety-four trials were included in narrative synthesis. Study quality was low. None of the trials justified their antithrombotic therapy protocol. Only 29% of trials had complete peri-procedural antithrombotic protocols, and 34% had complete post-procedural protocols. In total, 64 different peri-procedural protocols, and 51 separate post-procedural protocols were specified. Antiplatelet monotherapy and unfractionated heparin were the most common regimen choices in the peri-procedural setting, and dual antiplatelet therapy (55%) was most commonly utilised post procedure. Over time there has been an increasing tendency to use dual therapy (p < .001). This corresponds with the introduction of newer technologies and trials focussed on below knee intervention.
Randomised trials comparing different types of peripheral endovascular arterial intervention have a high level of heterogeneity in their antithrombotic regimens. Antiplatelet therapy needs to be standardised in trials comparing endovascular technologies to reduce potential confounding. To do this, an independent randomised trial specifically examining antiplatelet therapy following peripheral arterial endovascular intervention is needed.
新的外周动脉血管腔内介入治疗设备的随机试验定期公布。缺乏介入治疗后使用何种抗血小板和/或抗凝（抗血栓形成）治疗的证据。本系统评价的目的是检查外周动脉血管腔内介入随机试验中的抗血栓形成方案，以了解选择的方案以及随时间推移或器械类型的趋势。
资料来源为 Medline、Embase 和 Cochrane 图书馆数据库。纳入了患有外周动脉疾病并接受任何血管腔内动脉介入治疗的参与者的随机试验。评估试验方法以确定是否规定了抗血栓形成方案、其完整性以及规定的药物。抗血栓形成治疗方案被归类为围手术期（介入前和介入期间）、即刻术后（介入后 30 天内）和维持术后（超过 30 天的治疗）。
94 项试验被纳入叙述性综合分析。研究质量较低。没有一项试验证明其抗血栓形成治疗方案的合理性。只有 29%的试验有完整的围手术期抗血栓形成方案，34%的试验有完整的术后方案。总共规定了 64 种不同的围手术期方案和 51 种单独的术后方案。抗血小板单药治疗和普通肝素是围手术期最常见的方案选择，术后最常使用双联抗血小板治疗（55%）。随着时间的推移，使用双联治疗的趋势有所增加（p<.001）。这与较新技术的引入以及专注于膝下血管介入的试验相对应。
比较不同类型的外周血管腔内动脉介入治疗的随机试验在其抗血栓形成方案中存在高度异质性。在比较血管腔内技术的试验中，需要标准化抗血小板治疗以减少潜在的混杂因素。为此，需要进行一项专门研究外周动脉血管腔内介入后抗血小板治疗的独立随机试验。
