Division of Vascular and Endovascular Surgery, Ottawa Civic Hospital, Ottawa, Ontario, Canada
Department of Epidemiology, University of Ottawa, Ottawa, Ontario, Canada.
BMJ Open. 2021 May 18;11(5):e042980. doi: 10.1136/bmjopen-2020-042980.
Patients with peripheral arterial disease (PAD) are at increased risk for systemic arterial thromboembolic events. Females represent a unique subset of patients with PAD, who differ from males in important ways: they have smaller diameter vessels, undergo lower extremity bypass less frequently and experience higher rates of graft occlusion, amputation and mortality than males. Females also trend towards higher rates of major coronary events and cardiovascular mortality. Current guidelines recommend monoantiplatelet therapy (MAPT) for secondary prevention in patients with symptomatic PAD. However, indications for more intensive antithrombotic therapy in this cohort-especially among females who are frequently under-represented in randomised controlled trials (RCTs)-remain unclear. As newer antithrombotic therapies emerge, some RCTs have demonstrated differential effects in females versus males. A systematic review is needed to quantify the rates of arterial thromboembolic and bleeding events with different antithrombotic regimens in females with symptomatic PAD.
We will search MEDLINE, Embase and the Cochrane Central Register of Controlled trials for published RCTs that include females with symptomatic PAD and compare full dose anticoagulation±antiplatelet therapy, dual pathway inhibition or dual antiplatelet therapy with MAPT. Title, abstract and full-text screening will be conducted in duplicate by three reviewers. Authors will be contacted to obtain sex-stratified outcomes as needed. Risk of bias will be assessed using the Cochrane Risk of Bias tool. Data will be extracted by independent reviewers and confirmed by a second reviewer. Quantitative synthesis will be conducted using Review Manager (RevMan) V.5 for applicable outcomes data. Planned subgroup analysis by PAD severity, vascular intervention and indication for antithrombotics will be conducted where data permits.
Ethics approval is waived as the study does not involve primary data collection. This review will be submitted for publication in a peer-reviewed journal and for presentation at national and international scientific meetings.
This protocol was registered with the PROSPERO International Prospective Register of Systematic Reviews (ID# CRD42020196933).
患有外周动脉疾病 (PAD) 的患者发生全身动脉血栓栓塞事件的风险增加。女性是 PAD 患者的一个独特亚组，与男性在重要方面存在差异：她们的血管直径较小，下肢旁路手术的频率较低，并且比男性更容易发生移植物闭塞、截肢和死亡率。女性也倾向于发生更高的主要冠状动脉事件和心血管死亡率。目前的指南建议对有症状的 PAD 患者进行二级预防使用单一抗血小板治疗 (MAPT)。然而，在这一人群中，更强化的抗血栓治疗的指征——尤其是在经常在随机对照试验 (RCT) 中代表性不足的女性中——仍不清楚。随着新的抗血栓治疗方法的出现，一些 RCT 已经证明了女性与男性之间的不同效果。需要进行系统评价来量化不同抗血栓治疗方案在有症状的 PAD 女性中的动脉血栓栓塞和出血事件的发生率。
我们将在 MEDLINE、Embase 和 Cochrane 对照试验中心注册库中搜索包含有症状的 PAD 女性的已发表 RCT，比较全剂量抗凝治疗±抗血小板治疗、双重途径抑制或双重抗血小板治疗与 MAPT。将由三位评审员对标题、摘要和全文进行重复筛选。如有需要，将联系作者获取按性别分层的结果。使用 Cochrane 偏倚风险工具评估偏倚风险。数据将由独立评审员提取，并由第二位评审员确认。将使用 Review Manager (RevMan) V.5 对适用的结局数据进行定量合成。在数据允许的情况下，将按 PAD 严重程度、血管介入和抗血栓治疗指征进行计划的亚组分析。
由于该研究不涉及原始数据收集，因此豁免伦理批准。本综述将提交给同行评审期刊发表，并在国内外科学会议上报告。
本方案已在 PROSPERO 国际前瞻性系统评价登记册（ID# CRD42020196933）中注册。
